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Diagnostic Kit for Hepatitis A Virus Antibody (Colloidal Gold)
Diagnostic Kit for Hepatitis A Virus Antibody (Colloidal Gold)
Place of Origin:
China
Brand:
SPAN
Model:
HAV
Supplier:
Span Biotech Ltd
Price:
Negotiated
Hits:
275 
Updated:
4/25/2025
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    Diagnostic Kit for Hepatitis A Virus Antibody (Colloidal Gold)
                                                                                                                                
    INTENDED USE
    The HAV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis A type virus (HAV) in human serum/ plasma.
     
    PRINCIPLE
    HAV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HAV in human serum/plasma. Mouse anti human-IgM µ strands are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HAV recombinant antigens. If antibodies to HAV are present, a pink colored band will develop on the membrane in proportion to the amount of HAV antibodies present in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of antibodies to HAV.
     
    REAGENTS AND MATERIALS PROVIDED
    1.One sealed pouched cassette with desiccant & disposable pipettet.
    2.Blood diluent in a dropper bottle. Store at 4-30°C.
    3.One piece of operating instruction with 40 test pouches.  

    WARNING AND PRECAUTIONS
    1.For in vitro diagnostic uses only.
    2.All patient samples should be treated as if capable of transmitting diseases.
    3.Do not interchange reagents from different lots. Do not use test kit beyond expiration date.
    4.Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.  

    STORAGE AND STABILITY
    Store HAV Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.
     
    SAMPLE COLLECTION AND PREPARATION
    Plasma
    1.Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
    2.Separate the plasma by centrifugation.
    3.Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.  
    Serum
    1.Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
    2.Allow the blood to clot.
    3.Separate the serum by centrifugation.
    4.Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.  

    ASSAY PROCEDURE
    1. Carefully apply 3µl sample into a centrifuge tube with 1.5ml dilution, oscillate and mix them to diluted sample.
    2. Remove the test cassette from pouch by tearing.
    3. Add 50-80 ul or 2-3 drops of mixture into sample well.
    4. Observe the result in 20 minutes.
     
    INTERPRETATION OF RESULTS
    1.Negative: No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HAV antibody has been detected.
    2.Positive: In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains HAV antibodies.
    3.Invalid: If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.  

    PERFORMANCE CHARACTERISTICS
    850 HAV diagnostic samples were tested with the HAV Rapid Screen Test. The results are summarized in the table below.
     
    Diagnostic Sample type Number of sample tested HAV Rapid Screen Test
    negative Positive
    Positive 116 4 112
    Negative 734 728 6
     
    Sensitivity=96.6; Specificity=99.2%; Total accuracy=98.9%
     
    Precision
    Intra-assay
    In the study, 30 replicate assays were performed with one positive and one negative specimen. Correct negative and positive results were registered in 100% of the assays.
    Inter-assay
    The study involved the same specimens containing one positive and one negative. The samples were analyzed in 30 independent assays  with HAV Rapid Screen Test. Originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
     
    LIMITATION OF THE PROCEDURE
    1.The test is to be used for the qualitative detection of antibodies to HAV.
    2.A negative result does not rule out infection by HAV because the antibodies to HAV may be absent or may not be present in sufficient quantity to be detected at early stage of infection.  

    Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
     
    Our mission:
    • Always best of all and always pay attention to innovation.
    • Special customized service tightly following customers’ requests.
    • Integrated excellent quality, competitive prices and super service together.
     
    Packaging Details:
    Pouch+Box+Carton packaging
    (1) With our company’s Logo
    (2) With the natural package
    (3) With OEM package
    (4) ODM

    Rebecca Yan
     
    Product Manager                               
    Span Biotech Ltd.
    Tel:  +86(755)89589611
    Cell Phone:+8618823462100(WhatsApp)
    Web:
    bio-equip.cn
    Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
    Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
    Rapid Tests for Human Use :
    1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
    2) Infectious diseases: Hepatitis B, HCV, HIV
    3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
    4) Tumor markers: CEA, PSA, AFP, FOB
    5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
    6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
    Rapid Tests for Veterinary :
    1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
    2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
    3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
    Rapid Tests for Food Safety :
    1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
    2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol
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