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  • POCT series
    instrument
    Dry immunofluorescence analyzer(DFIA300)

    Dry immunofluorescence analyzer(DFIA300)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Cooperate with special single reagent strips to realize the quantitative detection of a series of immunoassay items.



    Supports single or multiple biomarkers for simultaneous detection and quantitative detection of a series of immunoassays


    Product Model:DFIA300


    Detection channel: 3 channels


    Detection principle: dry fluorescence immunoassay


    Sample type and blood volume requirements: serum, plasma, whole blood; ≤100µl


    Display: 8-inch touch screen


    Result transmission: support LIS transmission results



    Dry immunofluorescence analyzer(DFIA200)

    Dry immunofluorescence analyzer(DFIA200)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Cooperate with special single reagent strips to realize the quantitative detection of a series of immunoassay items.



    Product modelDFIA200
    Detection channel12-channel
    Detection principledry fluorescence immunoassay
    Sample typeserum, plasma, whole blood
    Blood volume requirements ≤100µl
    Detection speed≤ 15 minutes
    Display8-inch color screen
    Result transmissionsupport LIS transmission result
    Detection methodsupport one card one item, one card multiple data processing






    Dry immunofluorescence analyzer(DFIA100)

    Dry immunofluorescence analyzer(DFIA100)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Cooperate with special single reagent strips to realize the quantitative detection of a series of immunoassay items.



    Product modelDFIA100
    Detection channelsingle channel
    Detection principledry fluorescence immunoassay
    Sample typeserum, plasma, whole blood
    Blood volume requirements ≤100µl
    Detection speed≤ 15 minutes
    Display7-inch touch screen
    Result transmissionsupport LIS transmission result
    Detection methodsupport one card one item, one card multiple data processing







    1617871956542888.jpg

    Inflammatory Marker
    IL-6 Rapid Test Kit (Fluorescence immunochromatography)

    IL-6 Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Expected usage:

    The reagent is used for clinical in vitro quantitative detection of Interleukin-6 (IL-6) content in human serum, plasma, or whole blood samples, and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.



    Clinical significance:

    In the inflammatory response, IL-6 rises earlier than other indicators and lasts for a long time, so it can be used to assist in the early diagnosis of acute infection. Dynamic observation of IL-6 levels also helps to understand the progress of infectious diseases and the response to treatment.



    Applicable departments: 

    Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.




    Sample typeserum, plasma, whole blood
    Report time15min
    Reference rangeIL-6 ≤7pg/mL
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    CRP Rapid Test Kit (Fluorescence immunochromatography)

    CRP Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Expected usage:

    The reagent is used for clinical in vitro quantitative detection of C-reactive protein (CRP) content in human serum, plasma or whole blood. C-reactive protein is mainly used as a non-specific inflammation indicator.



    Clinical significance:

    Identify bacterial or viral infections and use it for dynamic observation of antibiotic efficacy. Monitor changes in the condition and postoperative infection. Disease course detection and prognosis judgment.



    Applicable departments:

    Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.


    Sample typeserum, plasma, whole blood
    Report time3min
    Reference rangehs-CRP≤1.0mg/L,CRP≤10 mg/L
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    PCT Rapid Test Kit (Fluorescence immunochromatography)

    PCT Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Expected usage:

    The reagent is used for clinical in vitro quantitative detection of procalcitonin (PCT) content in human serum, plasma, or whole blood samples, and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.


    Clinical significance: 

    Assist in the differential diagnosis of severe bacterial infections, sepsis and multiple organ failure Evaluation of the degree of infection and prognosis Instruct the rational use of antibiotics and the monitoring of efficacy.


    Applicable departments: 

    Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.



    Sample typeserum, plasma, whole blood
    Report time15min
    Reference rangePCT  0.5ng/mL
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications50 tests/box



    CRP/SAA Rapid Test Kit (Fluorescence immunochromatography)

    CRP/SAA Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Expected usage:

    The reagent is used for clinical in vitro quantitative detection of C-reactive protein and serum amyloid A content in human serum samples, mainly as non-specific inflammation indicators.

     


    Clinical significance:

    Differential diagnosis index for bacterial infection and viral infection



    Applicable departments:

    Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.



    Sample typeserum, plasma, whole blood
    Report time15min
    Reference rangeCRP≤10mg/L,SAA≤10mg/L
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications 25 tests/box, 50 tests/box


    PCT/IL-6 Rapid Test Kit (Fluorescence immunochromatography)

    PCT/IL-6 Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Expected usage:

    The reagent is used for clinical in vitro quantitative detection of procalcitonin (PCT) and Interleukin-6 (IL-6) content in human serum, plasma, or whole blood samples, PCT is mainly used in clinical diagnosis of bacterial infections. IL-6 is mainly used to monitor the immune status and inflammation of the body.



    Clinical significance

    Increasing the rate of early diagnosis of infection is a necessary test item for early warning and rapid diagnosis of sepsis and to guide the correct use of antibiotics.



    Applicable departments:

    Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.




    Sample typeserum, plasma, whole blood
    Report time15min
    Reference rangePCT  0.5ng/mLIL-6≤7pg/mL
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box





    SAA Rapid Test Kit (Fluorescence immunochromatography)

    SAA Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Expected usage:

    The reagent is used for clinical in vitro quantitative detection of SAA content in human serum, mainly as a non-specific inflammation indicator.



    Clinical significance: 

    Sensitive indicators to identify viral infections, combined with CRP and blood routine testing, can be used for early differential diagnosis, dynamic observation of curative effects and guidance of medication. Differential diagnosis of infectious diseases in children.



    Applicable departments:

    Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.



    Sample typeserum
    Report time10min
    Reference rangeSAA≤10mg/L
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    Cardiac marker
    Lp-PLA2 Rapid Test (Fluorescence immunochromatography)

    Lp-PLA2 Rapid Test (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Lp-PLA2: an emerging biomarker of coronary heart disease

    - Intravascular highly specific inflammatory factors

    - Independent risk predictors of cardiovascular and cerebrovascular diseases

    Lp-PLA2 induces an increase in plaque instability, making the plaque fragile and ruptured, leading to thrombosis and ischemic stroke. In addition, high levels of Lp-PLA2 predict increased instability of atherosclerotic plaques, more prone to rupture, and increased risk of cardiovascular and cerebrovascular malignant events.Schematic diagram of Lp-PLA2 is shown in Figure 1.

    Schematic diagram of Lp-PLA2 and plaque stability 1.png

    Figure 1

    Schematic diagram of Lp-PLA2 and plaque stability

    References:

    The international recognition and importance of Lp-PLA2 is gradually increasing, and it is recommended that Lp-PLA2 be used in various aspects of cardiovascular and cerebrovascular diseases such as screening, differential diagnosis, risk assessment, treatment and prognosis.Guideline Recommendation Table is shown in Figure 2.

    Lp-PLA2 guideline recommendations .png

    Figure 2

    Lp-PLA2 Guideline Recommendation Table


    Clinical significance: 

    -Dynamic monitor of the degree of inflammation in the vascular endothelium and atherosclerotic plaques

    -Risk estimation for coronary heart disease and stroke

    -Estimated risk of recurrence for various cardiovascular embolisms (stroke)

    -Efficacy assessment , the decreased level of Lp-PLA2 is positively correlated with the lipid-lowering effect of statins


    Applicable departments: 

    Cardiology, cardiac surgery, neurology, veteran department, endocrinology, laboratory department, physical examination center


    Sample typeserum, plasma, whole blood
    Report time15min
    Reference range
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    H-FABP Rapid Test (Fluorescence immunochromatography)

    H-FABP Rapid Test (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Acute coronary syndrome (ACS) is a major cause of morbidity and mortality worldwide, and it incurs huge healthcare expenditures [1-4]. In the United States alone, 683,000 discharge occurrences resulting from ACS were reported in 2009 [5,6]. Remarkably, 1,190,000 secondary discharges were associated with ACS, of which 829,000 were attributed to myocardial infarction (MI) alone [5,6]. ACS is caused by the sudden obstruction of a coronary artery. Early diagnosis and prompt treatment of ACS continues to be a diagnostic challenge in medicine, The highest risk of fatality occurs within the initial hours of onset of AMI. Thus, early diagnosis of cardiac ischemia is critical for the effective management of patients with AMI. Improper diagnosis of patients with chest pain often leads to inappropriate admission of patients without AMI and vice versa. In addition to clinical history, physical examination, accurate electrocardiogram findings and assessment of cardiac biomarkers have an important role in the early diagnosis of acute ischemia. 

    A  marker of Myocardial Injury

    H-FABP: It is a small-molecule soluble protein that is abundant in the cytoplasm of myocardium, but when myocardial cells are damaged, it can be quickly released into the blood, leading to a sharp increase in the level of H-FABP in the blood high.H-FABP can be used as a predictive biomarker of mortality following acute coronary syndrome (ACS).

    QQ截图20211229155047.png


    Clinical significance: 

    Detection for the early diagnosis and risk stratification of acute myocardial infarction Myocardial infarction area estimation Differential diagnosis of chest pain Prognostic evaluation of ACS



    Applicable departments: 

    Cardiology, chest pain center, stroke center, emergency department, ICU, cardiac surgery, neurology, respiratory, etc.



    Sample typeserum, plasma, whole blood
    Report time15min
    Reference rangeH-FABP≤7ng/ml
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    cTnl/CK-MB/Myo Rapid Test Kit

    cTnl/CK-MB/Myo Rapid Test Kit

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Acute coronary syndrome (ACS) is a major cause of morbidity and mortality worldwide, and it incurs huge healthcare expenditures [1-4]. In the United States alone, 683,000 discharge occurrences resulting from ACS were reported in 2009 [5,6]. Remarkably, 1,190,000 secondary discharges were associated with ACS, of which 829,000 were attributed to myocardial infarction (MI) alone [5,6]. ACS is caused by the sudden obstruction of a coronary artery. Early diagnosis and prompt treatment of ACS continues to be a diagnostic challenge in medicine, The highest risk of fatality occurs within the initial hours of onset of AMI. Thus, early diagnosis of cardiac ischemia is critical for the effective management of patients with AMI. Improper diagnosis of patients with chest pain often leads to inappropriate admission of patients without AMI and vice versa. In addition to clinical history, physical examination, accurate electrocardiogram findings and assessment of cardiac biomarkers have an important role in the early diagnosis of acute ischemia. 

    Myocardial Injury Marker:

    H-FABP: It is a small-molecule soluble protein that is abundant in the cytoplasm of myocardium, but when myocardial cells are damaged, it can be quickly released into the blood, leading to a sharp increase in the level of H-FABP in the blood high.H-FABP can be used as a predictive biomarker of mortality following acute coronary syndrome (ACS).

    CTnI: It is a contractile protein that exists only in the myocardium. It is one of the three subunits of troponin complex (I, T, C), and combines with tropomyosin in the filaments of myofibrils to form actin.

    Myo: Mainly present in the myocardium and skeletal muscle. When skeletal muscle and myocardium are damaged (acute myocardial infarction), excessive exercise and muscle diseases, myoglobin is released into the blood.The levels of MYO can therefore not be used as a single diagnostic marker, but in conjunction with the troponins or CK-MB. Thus, serum levels of MYO can be used to rule out, rather than diagnose, myocardial infarction ().

    CK-MB: a form of creatine kinase isoenzyme, which mainly exists in the myocardium. It is one of the important markers of myocardial injury and can effectively diagnose acute myocardial infarction.

     QQ截图20211229155047.png

    Joint detection

    QQ截图20211231133717.png

    The combined detection of the three items of myocardial infarction helps distinguish AMI patients in a timely and accurate manner, minimizes the damage, avoids missed diagnosis and misdiagnosis, and can win more precious time for timely rescue of patients with myocardial infarction.

    Multi-index combined detection can improve the detection rate and accuracy of myocardial injury, reduce the missed diagnosis rate, and reduce doctor-patient disputes.


    Clinical significance:

    Combined detection for early diagnosis and risk stratification of acute myocardial infarction Myocardial infarction area estimation differential diagnosis of chest pain Prognostic evaluation of ACS



    Applicable departments:

    Cardiology, chest pain center, stroke center, emergency department, ICU, cardiac surgery, neurology, respiratory, etc.



    Sample typeserum, plasma, whole blood
    Report time15min
    Reference rangecTnI≤0.3ng/ml,Myo≤58ng/ml,CK-MB≤5ng/ml
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications 25 tests/box, 50 tests/box


    Heart failure marker
    Growth-stimulating expression gene 2 protein (ST2)

    Growth-stimulating expression gene 2 protein (ST2)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    ST2: a novel biomarker for heart failure


    ST2 is a member of the interleukin-I(IL-1)receptor family. When the heart continues to be under pressure, the expression of ST2 increases, which indirectly promotes myocardial hypertrophy and myocardial fibrosis, affects cardiac function, and greatly increases the readmission and mortality of patients with heart failure.


    ST2 is released when cardiomyocytes stretch, neutralizing its ligand IL-33 (). It is also associated with inflammation during the MI and HF (3). As a decoy receptor of IL-33 receptor (ST2L), an appropriate amount of sST2 can prevent uncontrolled inflammation. However, redundant sST2 could also block the advantageous biological effect of IL-33 due to its competitive role against ST2L, which will eventually cause HF (). Recently, sST2 is frequently reported to be associated with CVDs, especially HF (). The ST2 pathway in CVD is shown in Figure 1.


    fcvm-08-697837-g0001.jpg




    Figure 1

    ST2 pathway in CVD

      


     













       

    Biomarkers have made a significant contribution to the diagnosis and prognosis of disease. Although strongly associated with inflammatory and autoimmune diseases, ST2 has also been found to play a role in the diagnosis and prognosis of CVD (47). As one of the isoforms of ST2, sST2 has recently become a promising prognostic indicator for patients diagnosed with HF and a useful tool for risk stratification (8). Due to its prognostic value, sST2 was recommended by the American College of Cardiology Foundation (ACC)/American Heart Association (AHA) as an important biomarker for monitoring HF patients in 2013 (9).


    ST2 yielded strong, independent predictive value for all-cause and cardiovascular mortality, and HF hospitalization in chronic HF, and deserves consideration to be part of a multimarker panel together with NT-proBNP and hs-TnT.




    Clinical significance: 














    • Auxiliary diagnosis of heart failure

    • For monitoring the efficacy of heart failure 

    • For risk stratification and prognostic risk assessment of heart failure 



    Applicable departments: 

    Emergency department, cardiac surgery, cardiology, chest pain center, Clinical Laboratory, ICU, CCU.


    References:

    1. Weinberg EO, Shimpo M, De Keulenaer GW, MacGillivray C, Tominaga S, Solomon SD, et al. Circulation. (2002) 

    2. Parikh RH, Seliger SL, Christenson R, Gottdiener JS, Psaty BM, deFilippi CR. J Am Heart Assoc. (2016) 

    3. Marino R, Magrini L, Orsini F, Russo V, Cardelli P, Salerno G, et al. Ann Lab Med. (2017) 

    4. Oshikawa K, Kuroiwa K, Tago K, Iwahana H, Yanagisawa K, Ohno S, et al. Am J Respir Crit Care Med. (2001) 

    5. Dudek M, Kałuzna-Oleksy M, Migaj J, Straburzyńska-Migaj E. Adv Clin Exp Med. (2020)

    6. McCarthy CP, Januzzi JL, Jr. Soluble ST2 in Heart Failure. Heart Fail Clin. (2018) 

    7. AbouEzzeddine OF, McKie PM, Dunlay SM, Stevens SR, Felker GM, Borlaug BA. Circulation. (2015) 
    8. Boisot S, Beede J, Isakson S, Chiu A, Clopton P, Januzzi J, et al. J Card Fail. (2008) 
    9. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Jr., Drazner MH, et al. . 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. (2013) 


    Sample type

    serum, plasma

    Report time15min
    Storage4-30℃, sealed and kept away from light and dry, the validity period is 18 months
    Specifications50 tests/box



    NT-proBNP Rapid Test Kit (Fluorescence immunochromatography)

    NT-proBNP Rapid Test Kit (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Heart failure (HF) biomarkers have dramatically impacted the way HF patients are evaluated and managed. B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are the gold standard biomarkers in determining the diagnosis and prognosis of HF, and studies on natriuretic peptide-guided HF management look promising. 


    NT-proBNP: A gold standard for Heart Failure


    International guidelines recommend the use of B-type natriuretic peptide testing in the diagnostic workup of Heart Failure (HF) in both acute and non-acute patient presentation(2).

    In the emergency department (ED), NT-proBNP is particularly useful for the triage of patients with acute dyspnea and suspected acute HF. It is highly sensitive and specific for exclusion (single rule-out cut-off value of 300 pg/mL) or confirmation of acute HF (age-adjusted rule-in cut-off values) (3).

    20220105英文彩页素材-NT-proBNP.jpg


    *The area between the rule-out (<300pg/mL) and the rule-in (age-ajusted) cut-off values is designated as the "gray zone".

    NT-proBNP in the evaluation and triage of ED patients with acute dyspnea (4) 


    In primary care, NT-proBNP is particularly useful to guide referral of symptomatic chronic HF to specialist care because it excludes suspected left ventricular systolic dysfunction. Compared with NT-proBNP values in patients with acute HF, lower values are expected in ambulatory chronic HF patients. International guidelines recommend a single low cut-off of 125pg/mL to rule out HF for patients presenting with non-acute symptoms. However peer-reviewed literature supports the use of age-dependent cut-offs to adjust for loss of specificity in such settings(5).

    QQ截图20220105135414.png

    NT-proBNP in the primary care setting 

    Clinical significance:

    Early elimination/diagnosis of heart failure, identification of causes of acute and chronic dyspnea Risk classification of patients with heart failure, prediction of adverse outcomes Efficacy monitoring, treatment guidance and prognosis evaluation for patients with heart failure


    Applicable departments:

    Cardiology, chest pain center, stroke center, emergency department, ICU, cardiac surgery, neurology, respiratory, etc.


    References:

    1. Moe G.W, Howlett J, Januzzi JL, et al.  Primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation 2007;115: 3103-3110.
    2. McMurray JJ, Adamopoulos S, Anker SD, et al.; ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: Eur Heart J. 2012;33:1787-847
    3. Januzzi JL, van Kimmenade R, et al. the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 ;27:330-7.
    4. Januzzi JL, Chen-Tournoux AA, Moe G. Am J Cardiol. 2008;101 (Suppl.):29A-38A.
    5. Hildebrandt P, Collinson PO, et al. Eur Heart J. 2010;31:1881-9.


    Sample typeserum, plasma, whole blood
    Report time15min
    Reference range<75 years old, NT-proBNP≤300 pg/ml,   ≥75 years old, NT-proBNP≤450 pg/ml
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications 25 tests/box, 50 tests/box


    Hormone
    Anti-Mullerian Hormone Detection Kit (AMH)

    Anti-Mullerian Hormone Detection Kit (AMH)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    AMH: a marker for ovarian reserve


    AMH is secreted by preantral follicles and small antral follicles in the ovary, and its level is directly related to the number of follicles in the ovary. Schematic model of AMH actions in the ovary that is shown in Figure 1

    Schematic model of AMH actions in the ovary.png

    Figure 1

    Schematic model of AMH actions in the ovary

      









      

    AMH is an indicator familiar to experts in gynecological endocrinology and assisted reproductive technology and is commonly used in ovarian reserve, ovarian responsiveness prediction, and PCOS disease diagnosis. AMH is the earliest hormone to change with age and is therefore a more accurate predictor of ovarian reserve in women at an earlier stage.


    ESHRE consensus on the definition of‘poor response’to ovarian stimulation for in vitro fertilization.

    AMH had the best sensitivity and specificity for predicting ovarian response.(Figure 2)

    QQ截图20220107165613.png

    Figure 2






    Clinical significance: 














    • Evaluation of ovarian reserve

    • Prediction of reproductive ovarian reactivity

    • Predicting menopause

    • Auxiliary diagnosis of ovarian related diseases in women (PCOS/POI)



    Applicable departments: 

    Physical examination center, reproductive center, gynecology, oncology, pediatrics



    References:

    1.NICE Clinical Guideline 156, 2013

    2.Visser JA.et,al. Nat Rev Endocrinol. 2012 Jan 10;8(6):331-41.

    3.Fleming R.et,al.Reprod Biomed Online. 2015 Oct;31(4):486-96.

    4.Dumont A.et,al. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):377-384.



    Sample type

    Serum, plasma ,whole blood


    Report time15min
    Storage4-30℃, sealed and kept away from light and dry, the validity period is 18 months
    Specifications25 tests/box ,50 tests/box



    Inhibin B Detection Kit (INH-B)

    Inhibin B Detection Kit (INH-B)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

     Female reproduction

    Inhibin B is secreted by the granulosa cells of small antral follicles in women and directly reflect ovarian reserve.

    → Male reproduction

    Inhibin B is produced by Sertoli cells in males, and its level reflects the function of the entire testicular tissue . Inhibin B is the best and most direct marker for evaluating male spermatogenesis.


    INH-B:a novel marker of spermatogenesis

    Subfertility affects about 15% of all couples. Assessment of spermatogenesis has a central role in the evaluation of the subfertile couple. Recently, the serum inhibin B level has emerged as a sensitive endocrine marker of spermatogenesis. The serum inhibin B level has been shown to be associated with classical markers of spermatogenesis, particularly testicular histology, and to be the most accurate endocrine marker of spermatogenesis. Schematic representation of the hypothala-mic-pituitary-testis axis in adulthood that is shown in Figure 1

    QQ截图20220119140833.png

    Figure 1

    Schematic representation of the hypothala-mic-pituitary-testis axis in adulthood

      









      

    Hypothalamic GnRH stimulates the pituitary secretion of FSH and LH. LH stimulates Leydig cells to produce testosterone (T). FSH and testosterone directly stimulate Sertoli cells, which in turn, regulate germ cell development. GnRH is under negative feedback control by testosterone, while pituitary secretion of LH and FSH is under feedback control by testosterone, and inhibin B causes selective inhibition of FSH production. Inhibin B is produced by Sertoli cells in interaction with specific germ cell types. GnRH = gonadotrophin-releasing hormone; FSH = follicle-stimulating hormone; LH = luteinising hormone. 


    Clinical significance:


     














    • Analysis of male infertility

    • Application of Testicular Sperm Aspiration (TESE) in Assisted Reproductive Technology

    • Auxiliary diagnosis of childhood precocious puberty



    Applicable departments: 

    Physical examination center, reproductive center, gynecology, oncology, pediatrics



    References:

    1.NICE Clinical Guideline 156, 2013.

    2.Visser JA.et,al. Nat Rev Endocrinol. 2012 Jan 10;8(6):331-41.

    3.Fleming R.et,al.Reprod Biomed Online. 2015 Oct;31(4):486-96.

    4.Dumont A.et,al. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):377-384.

    5.Pierik FH.et,al.Ann Med. 2003;35(1):12-20.



    Sample type

    Serum, plasma ,whole blood


    Report time15min
    Storage4-30℃, sealed and kept away from light and dry, the validity period is 18 months
    Specifications25 tests/box ,50 tests/box



    Gastric function
    G17/PGI/PGII Rapid Test (Fluorescence immunochromatography)

    G17/PGI/PGII Rapid Test (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification


    PG and G17 serum levels in combination with gastroscopy was a powerful approach to diagnosing early-stage GC.


    Gastroscopy followed by examinations of biopsy specimens is the gold standard for diagnosing gastric cancer (GC). A disadvantage of this method is that it is invasive and causes discomfort and pain, making it an undesirable procedure for diagnostics.  Several attempts have been made to detect precancerous lesions and early-stage GC in high incidence areas by examining serum levels of pepsinogen (PG) and gastrin-17 (G17), which could offer an effective and non-invasive alternative to traditional gastroscopy for diagnosing GC.13 . Three Introductions to Stomach Function is shown in Figure 1.


    2345截图20220413141225.png

    Figure 1

    Three Introductions to Stomach Function


    PGI   Mainly secreted by chief cells and mucous neck cells of fundic glands. PGI was negatively correlated with atrophic gastritis in the fundus and corpus, and positively correlated with peptic ulcer.

    PGII  It is secreted by all gastric glands and duodenum. PGII is positively correlated with gastric ulcer, duodenal ulcer and Hp infection.

    PGR (PGI/PGII)  Decreased PGI and normal PGII: The progressive decrease of PGR is related to the progress of gastric mucosal atrophy and gastric fundus.

    G17  is secreted by G cells in the gastric antrum, and there is a strict negative feedback mechanism with gastric acid level, which is negatively correlated with atrophic gastritis of the gastric antrum.


    Clinical significance: 

    - Screening for gastric ulcer, atrophic gastritis, and early gastric cancer

    - Determination index of recurrence after gastric cancer resection

    Determination index for recurrence and cure of peptic ulcer

    Dynamic monitoring of individual gastric mucosal function

    Stomach Health Checkup for Physical Examination People


    Applicable departments: 

    Gastroenterology, oncology, physical examination center, surgery


    Sample typeserum, plasma, whole blood
    Report time15min
    Reference range
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    Renal Marker
    MAU (Fluorescence immunochromatography)

    MAU (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

    In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

    NGAL        The best index for early diagnosis of acute kidney injury

    CYS-C     The best endogenous index of glomerular filtration rate

    β2-MG      Monitoring indicators of proximal tubule function

    MAU         Sensitive indicator of early or mild kidney injury

    Microalbuminuria (MAU)

    MAU is the most sensitive and reliable diagnostic indicator for early detection of renal disease. When the kidney is damaged, the urinary albumin excretion rate exceeds the normal range, which reflects the damage of glomerular filtration function and renal tubular reabsorption function. Combined with the incidence, symptoms and medical history statement, it can be more accurate to diagnose the condition.


    Clinical significance: 

    - Important indicators for early diagnosis of hypertension and diabetic nephropathy

    - Early indications of changes in the kidneys and cardiovascular system

    - Auxiliary diagnosis for glomerular injury

    - Surveillance of pregnancy-induced hypertensive kidney injury


    Applicable departments: 

    Nephrology, emergency, interventional, ICU, cardiology, surgery


    Sample typeurine
    Report time10 min
    Reference range
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    β2-MG Rapid Test (Fluorescence immunochromatography)

    β2-MG Rapid Test (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

    In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

    NGAL        The best index for early diagnosis of acute kidney injury

    CYS-C     The best endogenous index of glomerular filtration rate

    β2-MG      Monitoring indicators of proximal tubule function

    MAU         Sensitive indicator of early or mild kidney injury

    β2 Microglobulin (β2-MG)


    The synthesis rate of β2-MG in healthy people is very stable, and it is only decomposed and excreted by the kidneys, and is not affected by factors such as age, gender, and muscle. The increase of β2-MG in plasma reflects the impairment of glomerular filtration function or the increase of filtration load; the increase of β2-MG in urine indicates the increase of renal tubular damage or load.


    Clinical application of blood β2-MG:


    For estimation of renal function disorders

     a. Assessment of renal impairment in hypertension and  diabetes

     b. Dynamic observation and diagnosis of renal transplant rejection

    Prognosis and therapeutic effect evaluation of malignant tumor diseases

    - Autoimmune disease assessment and efficacy monitoring


    Clinical application value of urinary β2-MG


    - Sensitive and specific method for the diagnosis of proximal convoluted tubule damage

    - For the identification of upper and lower urinary tract infections

    Used to determine rejection of kidney transplantation, and a marked increase is seen several days before rejection  


    Applicable departments: 

    Nephrology, emergency, interventional, ICU, cardiology, surgery


    Sample typeserum, plasma, whole blood,urine
    Report time10min
    Reference range
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    CYS-C Rapid Test (Fluorescence immunochromatography)

    CYS-C Rapid Test (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

    In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

    NGAL        The best index for early diagnosis of acute kidney injury

    CYS-C     The best endogenous index of glomerular filtration rate

    β2-MG      Monitoring indicators of proximal tubule function

    MAU         Sensitive indicator of early or mild kidney injury

    Cystatin C (CYS-C)

    CYS-C is produced at a constant rate in the body and is almost completely filtered by the glomerulus. CYS-C in the blood is not affected by changes in inflammation, sex, muscle, and age, but its concentration varies with the glomerular filtration rate (GFR) changes.


    Clinical significance: 

    Reflects the functional level of glomerular filtration

    - Early diagnosis and condition monitoring of kidney disease

    - Renal function monitoring in patients with kidney transplantation and chemotherapy

    Early prevention and diagnosis of early renal damage in AKI high-risk population

    Renal function assessment in patients with cirrhosis


    Applicable departments: 

    Nephrology, emergency, interventional, ICU, cardiology, surgery


    Sample typeserum, plasma, whole blood
    Report time5min
    Reference range
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


    NGAL Rapid Test (Fluorescence immunochromatography)

    NGAL Rapid Test (Fluorescence immunochromatography)

    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

    In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

    NGAL        The best index for early diagnosis of acute kidney injury

    CYS-C     The best endogenous index of glomerular filtration rate

    β2-MG      Monitoring indicators of proximal tubule function

    MAU         Sensitive indicator of early or mild kidney injury

    Neutrophil Gelatinase-Associated  Lipocalin (NGAL)

    NGAL is a member of the lipocalin family and normally maintains low levels in urine and blood. In the early stage (2h) of acute kidney injury (AKI), the level of NGAL in urine and blood increased significantly, and NGAL appeared before other indicators. Therefore, NGAL is one of the most effective biomarkers for the diagnosis of AKI, and its changes are earlier and more significant than traditional AKI diagnostic indicators.

    Clinical significance: 

    - The best index for early diagnosis of AKI

    - Chronic kidney disease, early detection of diabetic nephropathy

    - Early detection and prognostic evaluation of AKI complicated by various operations

    - Prognostic evaluation of kidney injury complicated by renal transplantation

    Early diagnosis of cardiovascular disease patients and ICU patients complicated with renal disease


    Applicable departments: 

    Nephrology, emergency, interventional, ICU, cardiology, surgery


    Sample typeserum, plasma, whole blood,urine
    Report time15min
    Reference range
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications25 tests/box, 50 tests/box


  • Molecular diagnostic series
    Human BRAF gene mutation detection kit (Fluorescence PCR method)

    Human BRAF gene mutation detection kit (Fluorescence PCR method)

    Features

    For qualitatively detect BRAF gene V600E mutation (ie 1799T>A)

    Evaluate gene mutation status by detecting DNA samples, assist in the diagnosis of thyroid cancer, and select tumor-targeted drugs for clinicians in patients with melanoma, colorectal cancer, thyroid cancer or lung cancer Provide reference for treatment. 

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Auxiliary diagnosis of thyroid cancer and select tumor-targeted drugs for clinicians in patients with melanoma, colorectal cancer, thyroid cancer or lung cancer Provide reference for treatment.


    Various sample types paraffin-embedded pathological tissue, sectioned tissue, fresh tissue, frozen tissue
    Easy to operatewithout special equipment, 90min completion detection, detection closed tube, without subsequent processing
    Reliable test resultsintuitive and easy to interpret; high precision, CV≤5%; high sensitivity, can detect 1% of B-raf gene mutations




    Conventional fluorescence quantitative PCR instrument


    Hepatitis B virus (HBV) nucleic acid detection kit (fluorescence PCR method)

    Hepatitis B virus (HBV) nucleic acid detection kit (fluorescence PCR method)

    Features

    - For in vitro quantitative detection of HBV DNA in human serum or plasma  

    - Response and treatment monitoring for antiviral therapy

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    For in vitro quantitative detection of HBV DNA in human serum or plasma


    High sensitivitythe lowest detection limit is 10 IU/ml;
    Wide linear range20-2×109 IU/ml
    Wide gene coverageA, B, C, D, E, F, G, H
    Set internal standardcan prevent false negatives from appearing
    Set up dUTP+UNG enzyme anti-pollution systemprevent product contamination
    Good repeatability

    the precision between batches and batches are ≤5%

    Good specificityno cross-reaction in detection of multiple pathogens
    Strong anti-interference abilitythe detection will not be affected under the peak concentration of a variety of antiviral drugs

    Conventional fluorescence quantitative PCR instrument

    Nucleic acid extraction reagent

    Nucleic acid extraction reagent

    Features

    It is suitable for the nucleic acid extraction of whole blood, serum, plasma, tissue, bone marrow, paraffin-embedded tissue or section, urine, culture medium supernatant, cell-free body fluid, swab, tissue homogenate supernatant, cell culture medium, etc,enrichment and purification.

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    It is suitable for the nucleic acid extraction of whole blood, serum, plasma, tissue, bone marrow, paraffin-embedded tissue or section, urine, culture medium supernatant, cell-free body fluid, swab, tissue homogenate supernatant, cell culture medium, etc. Enrichment and purification.


    The processed product is used for clinical in vitro testing.



     High-quality nucleic acidPurified nucleic acid has the characteristics of high concentration, high purity, and good integrity
    Wide application range can handle various types of samples
    Wide range of applications to meet various downstream applications, such as PCR, quantitative PCR, restriction enzyme digestion, blot hybridization, etc.



    1617957797130252.jpg

  • MPA method
    * HPV DNA 15/31 Type

    * HPV DNA 15/31 Type

    Features

    International Patent Technology

    Easy to operate (Nucleic acid extraction, PCR amplification, Interpretation of results < 3 hours)

    One 96-throughput thermal cycler can detect 94 samples in a single batch, more efficient

    Fully automatic data analysis software, result interpretation is smarter and faster

    High sensitivity, strong specificity

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Cervical cancer is the fourth most frequently occurring cancer in women around the world, also affecting young women during their reproductive years, and estimated to kill 250,000 women annually.  Since the development of the Papanicolaou (Pap) test, screening has been essential in identifying cervical cancer at a treatable stage. With the identification of the human papillomavirus (HPV) as the causative agent of essentially all cervical cancer cases, HPV molecular screening tests and HPV vaccines for primary prevention against the virus have been developed. HPV is however the most commonly acquired sexually transmitted virus, with around four out of five people (80%) contracting this infection at some point during their lifetime.

    Currently available HPV tests are unable to discriminate HPV infections regressing spontaneously from those turning into cancer.  Screening refusal is also an important problem in several European countries, mainly as a result of social, economic and/or racial/ethnic barriers, hindering cervical cancer prevention in these women. This, together with current failure to implement gender-neutral HPV vaccination with high coverage in the great majority of countries,  have resulted in IARC’s projections showing that, unless innovative preventive measures are implemented promptly, the burden of cervical cancer is expected to increase to almost 460.000 deaths per year by 2040, an increase of nearly 50% over the estimated number of deaths in 2018.

     

    Recommendation

    WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, 2021.

     HPV DNA testing as preferred method for cervical cancer screening


    Clinical significance: 





    • Expanded testing for HPV types that cause cervical cancer

    In addition to the 14 high-risk HPV types announced by WHO, the detection of intermediate-risk HPV types that may cause cancerous cells is added.


    Aids in the diagnosis of skin warts and genital related disorders

    Includes testing for types 6 and 11 for HPV vaccine prophylaxis and testing for many other low-risk HPV types that cause skin warts.


    Prognosis of oropharyngeal carcinoma and establishment of individualized treatment plan

    Patients with HPV-positive oropharyngeal cancer have better treatment effect and prognosis than HPV-negative 


    patients, and de-escalation of treatment is an option.

    HPV E6/E7 mRNA Genotype

    HPV E6/E7 mRNA Genotype

    Features

    International Patent Technology

    Easy to operate (Nucleic acid extraction, PCR amplification, Interpretation of results < 3 hours)

    One 96-throughput thermal cycler can detect 94 samples in a single batch, more efficient

    Fully automatic data analysis software, result interpretation is smarter and faster

    High sensitivity, strong specificity


    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Cervical cancer is the fourth most frequently occurring cancer in women around the world, also affecting young women during their reproductive years, and estimated to kill 250,000 women annually.  Since the development of the Papanicolaou (Pap) test, screening has been essential in identifying cervical cancer at a treatable stage. With the identification of the human papillomavirus (HPV) as the causative agent of essentially all cervical cancer cases, HPV molecular screening tests and HPV vaccines for primary prevention against the virus have been developed. HPV is however the most commonly acquired sexually transmitted virus, with around four out of five people (80%) contracting this infection at some point during their lifetime.

    Currently available HPV tests are unable to discriminate HPV infections regressing spontaneously from those turning into cancer.  Screening refusal is also an important problem in several European countries, mainly as a result of social, economic and/or racial/ethnic barriers, hindering cervical cancer prevention in these women. This, together with current failure to implement gender-neutral HPV vaccination with high coverage in the great majority of countries,  have resulted in IARC’s projections showing that, unless innovative preventive measures are implemented promptly, the burden of cervical cancer is expected to increase to almost 460.000 deaths per year by 2040, an increase of nearly 50% over the estimated number of deaths in 2018.

     

     

    Recommendation

    WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, 2021.

     HPV DNA testing as preferred method for cervical cancer screening


    Clinical significance: 





    • Expanded testing for HPV types that cause cervical cancer

    In addition to the 14 high-risk HPV types announced by WHO, the detection of intermediate-risk HPV types that may cause cancerous cells is added.


    Aids in the diagnosis of skin warts and genital related disorders

    Includes testing for types 6 and 11 for HPV vaccine prophylaxis and testing for many other low-risk HPV types that cause skin warts.


    Prognosis of oropharyngeal carcinoma and establishment of individualized treatment plan

    Patients with HPV-positive oropharyngeal cancer have better treatment effect and prognosis than HPV-negative 


    patients, and de-escalation of treatment is an option

    * Respiratory 12/15-item Pathogen Nucleic Acid Detection Kit

    * Respiratory 12/15-item Pathogen Nucleic Acid Detection Kit

    Features

    Avoid missed tests for multiple infections/combinations multiple/combined infections effective information

    Analysis software: realizing automatic interpretation 

    The minimum detection limit is not higher than 1000 copies/ml, with high accuracy and specificity. 

    Melting curve analysis method: detecting 12  pathogens respectively. 

    Fast reaction (5-10 minutes)

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Respiratory tract infections are divided into upper respiratory tract infections and lower respiratory tract infections. Upper respiratory tract infections mainly manifest as fever, headache, tinnitus, cough, runny nose, nasal congestion, etc., and are dominated by viruses, accounting for 70% to 80%. Lower respiratory tract infections include pneumonia, tracheitis, bronchitis, capillary bronchitis, etc. Usually, lower respiratory tract infections are much more serious than upper respiratory tract infections, and the pathogens are more complex.

    Acute upper respiratory infections occur in most people every year, 2 to 4 times per year in adults and in children at a higher rate of 6 to 8 times per year



    Clinical significance: 






    • Early Identification

    Direct detection of pathogens, shorten pathogen reporting time, improve the pathogen detection rate, and improve detection of mixed infections


    • Precise treatment

    Timely and accurate pathogenic results can promote the rational use of antibacterial drugs, facilitate infection control, and improve patient prognosis


    • Conserve medical resources

    Optimize the treatment process, shorten hospital stays, and reduce treatment costs, resulting in clinical and economic benefits


    • Epidemic prevention and control

    Screening and early warning of respiratory diseases, helping to normalize epidemic prevention and control, reducing the spread of respiratory diseases and infections in groups


  • STH-PAS method
    Five-term Sexually Transmitted Diseases Pathogens Test Kit

    Five-term Sexually Transmitted Diseases Pathogens Test Kit

    Features

    Five-term Respiratory Pathogens Test Kit

    Seven-term Respiratory Pathogens Test Kit

    Four-term Sexually Transmitted Diseases Pathogens Test Kit

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification


    PCR amplification reagent

    The PCR amplification reaction uses the patented technology STH-PAS (Single Tag Hybridization-Printed Array Strip), 

    through a pair of 5'-end specially modified specific primers, with PCR reaction solution, hot-start Taq enzyme and other components for specificity PCR amplification.


    Detection device 

    Followed by reconstitution and release of the PCR amplification product and blue latex microspheres in the detection device, 

    and the released amplification product hybridizes with the probe on the membrane strip and fixes it. Make a qualitative interpretation by the presence or absence of blue bands.



    Advantage:

    - Disposable anti-pollution detection device with the principle of physical isolation, does not need to open the cover to process PCR amplification products, which can effectively avoid false positives caused by aerosol diffusion of PCR amplification products. 


    - Adopts the dUTP-UNG enzyme anti-pollution system,eliminating the existing U-DNA pollutants in the reaction system or the environment.


    - Equipped with internal standard system, negative control and positive control,participates in the parallel extraction and detection of sample nucleic acid.


    Operate video: 

    Product name: 

    QQ截图20220623142034.png


    Seven-term Respiratory Pathogens Test Kit

    Seven-term Respiratory Pathogens Test Kit

    Features

    Five-term Respiratory Pathogens Test Kit

    Seven-term Respiratory Pathogens Test Kit

    Four-term Sexually Transmitted Diseases Pathogens Test Kit

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification


    PCR amplification reagent

    The PCR amplification reaction uses the patented technology STH-PAS (Single Tag Hybridization-Printed Array Strip), 

    through a pair of 5'-end specially modified specific primers, with PCR reaction solution, hot-start Taq enzyme and other components for specificity PCR amplification.


    Detection device 

    Followed by reconstitution and release of the PCR amplification product and blue latex microspheres in the detection device, 

    and the released amplification product hybridizes with the probe on the membrane strip and fixes it. Make a qualitative interpretation by the presence or absence of blue bands.



    Advantage:

    - Disposable anti-pollution detection device with the principle of physical isolation, does not need to open the cover to process PCR amplification products, which can effectively avoid false positives caused by aerosol diffusion of PCR amplification products. 


    - Adopts the dUTP-UNG enzyme anti-pollution system,eliminating the existing U-DNA pollutants in the reaction system or the environment.


    - Equipped with internal standard system, negative control and positive control,participates in the parallel extraction and detection of sample nucleic acid.


    Operate video: 

    Product name: 

    QQ截图20220623142034.png


    Five-term Respiratory Pathogens Test Kit

    Five-term Respiratory Pathogens Test Kit

    Features

    Five-term Respiratory Pathogens Test Kit

    Seven-term Respiratory Pathogens Test Kit

    Four-term Sexually Transmitted Diseases Pathogens Test Kit

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification


    PCR amplification reagent

    The PCR amplification reaction uses the patented technology STH-PAS (Single Tag Hybridization-Printed Array Strip), 

    through a pair of 5'-end specially modified specific primers, with PCR reaction solution, hot-start Taq enzyme and other components for specificity PCR amplification.


    Detection device 

    Followed by reconstitution and release of the PCR amplification product and blue latex microspheres in the detection device, 

    and the released amplification product hybridizes with the probe on the membrane strip and fixes it. Make a qualitative interpretation by the presence or absence of blue bands.



    Advantage:

    - Disposable anti-pollution detection device with the principle of physical isolation, does not need to open the cover to process PCR amplification products, which can effectively avoid false positives caused by aerosol diffusion of PCR amplification products. 


    - Adopts the dUTP-UNG enzyme anti-pollution system,eliminating the existing U-DNA pollutants in the reaction system or the environment.


    - Equipped with internal standard system, negative control and positive control,participates in the parallel extraction and detection of sample nucleic acid.


    Operate video: 

    Product name: 

    QQ截图20220623142034.png


  • Novel coronavirus (COVID-19) series
    COVID-19 Ag Rapid Test Kit (Immuno-Chromatography)

    COVID-19 Ag Rapid Test Kit (Immuno-Chromatography)

    Features

    Flexible samples: nasopharyngeal swabs, oropharyngeal swabs, deep sputum, etc

    Quick screening: results can be interpreted in 15 minutes

    Manual interpretation: no equipment is needed, easy for general medical institutions to develop

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    The reagent is used for clinical in vitro qualitative detection of novel coronavirus antigens in human throat swabs and other in vitro samples. This kit uses the principle of immuno-chromatography technology to detect the novel coronavirus (COVID-19) antigen in human throat swab samples using the double antibody sandwich method. 


    Product advantage

    产品优势.png

    TEST PROCEDURE

    操作过程.png


    Sample typenasopharyngeal swab, oropharyngeal swab, deep sputum
    Report time15min
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications50 tests/box






    COVID-19 IgM/IgG Rapid Test Kit (colloidal Gold Chromatography)

    COVID-19 IgM/IgG Rapid Test Kit (colloidal Gold Chromatography)

    Features

    Flexible samples: fingertip whole blood (no need for centrifugation), serum, plasma

    Quick screening: results can be interpreted in 15 minutes

    Differentiating types: combined detection and distinguishing IgM/IgG antibodies

    Manual interpretation: no equipment is needed, easy for general medical institutions to carry out a wide range

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    The reagent is used for the clinical in vitro qualitative detection of new coronavirus (2019-nCoV) antibodies in human serum, plasma or whole blood. 

    It is only used as a supplementary test indicator for suspected cases with a negative nucleic acid test of the new coronavirus or used in conjunction with nucleic acid testing in the diagnosis of suspected cases. 

    It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by new coronavirus infection, and is not suitable for screening of the general population. Only for medical institutions. 


    Product advantage

    1639463481980177.png


    Sample typeserum, plasma, whole blood,fingertip blood
    Report time15min
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications 50 tests/box




    Virus Transfer Medium

    Virus Transfer Medium

    Features

    VTM tube with different types of swabs, easy to use

    After sampling, it can be used for subsequent PCR detection or virus culture   

    Multiple configurations for different needs

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Viral Transport Medium (VTM) is ideal for diagnosis of viral infection.  Ocular, respiratory and tissue swabs can be submitted in this medium.  Fluid samples such as tracheal wash specimens or peritoneal fluid should be submitted as is, in sterile vials which prevent desiccation.  Cotton, plastic, wood-handled, and Dacron and other synthetic swabs are all acceptable.

    Product advantage

    1639465435115742.png

    Instruction manual

    1639465306411943.png


    1617939602628264.png

    The Novel Coronavirus(2019-nCoV) Nucleic Acid test kit (RT-PCR)

    The Novel Coronavirus(2019-nCoV) Nucleic Acid test kit (RT-PCR)

    Features

    Reliable one-step real-time PCR detection results

    High sensitivity and good specificity

    Including IC, PC, NC to monitor the sampling and reaction process

    Easy to use, compatible with most RT-PCR instruments (4 channels)

    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    The 2019 novel coronavirus (2019-nCoV), is a contagious virus that causes respiratory infection and has shown evidence of human-to-human transmission, first identified by authorities, as the cause of coronavirus outbreak all over the world.  Genomic sequencing has shown that it is a positive-sense, single-stranded RNA coronavirus.  Rapid and accurate screening methods are highly desirable so that the correct treatment can be provided and to prevent further spread of such contagious infections.

    The new coronavirus (2019 nCoV) nucleic acid detection kit is a single-closed test tube detection method for detecting coronavirus based on in vitro real-time PCR.


    Product advantage

    1639468550712175.png

    Test procedure

    1639468635569353.png


    Performance parameter

    QQ截图20211214155150.png


    Sample typenasopharyngeal swab, oropharyngeal swab, deep sputum
    Report time15h
    Storage -15°C
    Validity period12 months
    Specifications48 tests/box






  • MORE
    more

    more

    Features
    contact us
    • Usage
    • Specification
    • Applicable Instrument
    • Product Information

    1656060034509711.jpg

  • Growth-stimulating expression gene 2 protein (ST2)

    Growth-stimulating expression gene 2 protein (ST2)

    Features

    Rapid detection of single reagent (15 minutes)

    Convenient storage and transportation at room temperature

    contact us
    • Intended use
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    ST2: a novel biomarker for heart failure


    ST2 is a member of the interleukin-I(IL-1)receptor family. When the heart continues to be under pressure, the expression of ST2 increases, which indirectly promotes myocardial hypertrophy and myocardial fibrosis, affects cardiac function, and greatly increases the readmission and mortality of patients with heart failure.


    ST2 is released when cardiomyocytes stretch, neutralizing its ligand IL-33 (). It is also associated with inflammation during the MI and HF (3). As a decoy receptor of IL-33 receptor (ST2L), an appropriate amount of sST2 can prevent uncontrolled inflammation. However, redundant sST2 could also block the advantageous biological effect of IL-33 due to its competitive role against ST2L, which will eventually cause HF (). Recently, sST2 is frequently reported to be associated with CVDs, especially HF (). The ST2 pathway in CVD is shown in Figure 1.


    fcvm-08-697837-g0001.jpg




    Figure 1

    ST2 pathway in CVD

      


     













       

    Biomarkers have made a significant contribution to the diagnosis and prognosis of disease. Although strongly associated with inflammatory and autoimmune diseases, ST2 has also been found to play a role in the diagnosis and prognosis of CVD (47). As one of the isoforms of ST2, sST2 has recently become a promising prognostic indicator for patients diagnosed with HF and a useful tool for risk stratification (8). Due to its prognostic value, sST2 was recommended by the American College of Cardiology Foundation (ACC)/American Heart Association (AHA) as an important biomarker for monitoring HF patients in 2013 (9).


    ST2 yielded strong, independent predictive value for all-cause and cardiovascular mortality, and HF hospitalization in chronic HF, and deserves consideration to be part of a multimarker panel together with NT-proBNP and hs-TnT.




    Clinical significance: 














    • Auxiliary diagnosis of heart failure

    • For monitoring the efficacy of heart failure 

    • For risk stratification and prognostic risk assessment of heart failure 



    Applicable departments: 

    Emergency department, cardiac surgery, cardiology, chest pain center, Clinical Laboratory, ICU, CCU.


    References:

    1. Weinberg EO, Shimpo M, De Keulenaer GW, MacGillivray C, Tominaga S, Solomon SD, et al. Circulation. (2002) 

    2. Parikh RH, Seliger SL, Christenson R, Gottdiener JS, Psaty BM, deFilippi CR. J Am Heart Assoc. (2016) 

    3. Marino R, Magrini L, Orsini F, Russo V, Cardelli P, Salerno G, et al. Ann Lab Med. (2017) 

    4. Oshikawa K, Kuroiwa K, Tago K, Iwahana H, Yanagisawa K, Ohno S, et al. Am J Respir Crit Care Med. (2001) 

    5. Dudek M, Kałuzna-Oleksy M, Migaj J, Straburzyńska-Migaj E. Adv Clin Exp Med. (2020)

    6. McCarthy CP, Januzzi JL, Jr. Soluble ST2 in Heart Failure. Heart Fail Clin. (2018) 

    7. AbouEzzeddine OF, McKie PM, Dunlay SM, Stevens SR, Felker GM, Borlaug BA. Circulation. (2015) 
    8. Boisot S, Beede J, Isakson S, Chiu A, Clopton P, Januzzi J, et al. J Card Fail. (2008) 
    9. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Jr., Drazner MH, et al. . 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. (2013) 


    Sample type

    serum, plasma

    Report time15min
    Storage4-30℃, sealed and kept away from light and dry, the validity period is 18 months
    Specifications50 tests/box



  • NT-proBNP Rapid Test Kit (Fluorescence immunochromatography)

    NT-proBNP Rapid Test Kit (Fluorescence immunochromatography)

    Features

    Applicable to various sample types of serum, plasma and whole blood

    Rapid detection of single reagent (15 minutes)

    Convenient storage and transportation at room temperature

    contact us
    • Intended use
    • Specification
    • Applicable Instrument
    • Product Information

    Successfully obtained in the EU CE access certification

    Passed ISO13485 certification

    Heart failure (HF) biomarkers have dramatically impacted the way HF patients are evaluated and managed. B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are the gold standard biomarkers in determining the diagnosis and prognosis of HF, and studies on natriuretic peptide-guided HF management look promising. 


    NT-proBNP: A gold standard for Heart Failure


    International guidelines recommend the use of B-type natriuretic peptide testing in the diagnostic workup of Heart Failure (HF) in both acute and non-acute patient presentation(2).

    In the emergency department (ED), NT-proBNP is particularly useful for the triage of patients with acute dyspnea and suspected acute HF. It is highly sensitive and specific for exclusion (single rule-out cut-off value of 300 pg/mL) or confirmation of acute HF (age-adjusted rule-in cut-off values) (3).

    20220105英文彩页素材-NT-proBNP.jpg


    *The area between the rule-out (<300pg/mL) and the rule-in (age-ajusted) cut-off values is designated as the "gray zone".

    NT-proBNP in the evaluation and triage of ED patients with acute dyspnea (4) 


    In primary care, NT-proBNP is particularly useful to guide referral of symptomatic chronic HF to specialist care because it excludes suspected left ventricular systolic dysfunction. Compared with NT-proBNP values in patients with acute HF, lower values are expected in ambulatory chronic HF patients. International guidelines recommend a single low cut-off of 125pg/mL to rule out HF for patients presenting with non-acute symptoms. However peer-reviewed literature supports the use of age-dependent cut-offs to adjust for loss of specificity in such settings(5).

    QQ截图20220105135414.png

    NT-proBNP in the primary care setting 

    Clinical significance:

    Early elimination/diagnosis of heart failure, identification of causes of acute and chronic dyspnea Risk classification of patients with heart failure, prediction of adverse outcomes Efficacy monitoring, treatment guidance and prognosis evaluation for patients with heart failure


    Applicable departments:

    Cardiology, chest pain center, stroke center, emergency department, ICU, cardiac surgery, neurology, respiratory, etc.


    References:

    1. Moe G.W, Howlett J, Januzzi JL, et al.  Primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation 2007;115: 3103-3110.
    2. McMurray JJ, Adamopoulos S, Anker SD, et al.; ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: Eur Heart J. 2012;33:1787-847
    3. Januzzi JL, van Kimmenade R, et al. the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 ;27:330-7.
    4. Januzzi JL, Chen-Tournoux AA, Moe G. Am J Cardiol. 2008;101 (Suppl.):29A-38A.
    5. Hildebrandt P, Collinson PO, et al. Eur Heart J. 2010;31:1881-9.


    Sample typeserum, plasma, whole blood
    Report time15min
    Reference range<75 years old, NT-proBNP≤300 pg/ml,   ≥75 years old, NT-proBNP≤450 pg/ml
    Storage4-30℃, sealed and kept away from light and dry
    Validity period18 months
    Specifications 25 tests/box, 50 tests/box