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Covid-19 Ag Cassette Uncut Sheet
Covid-19 Ag Cassette Uncut Sheet
Place of Origin:
Span Biotech Ltd.
Covid Ag
  • Product Detail
  • Company Profile


    The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigensin nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.

    Results are for the identification of SARS-CoV-2 nucleocapsid antigen.Antigen is generally detectable in nasopharyngeal swab and oropharyngeal

    swab during the acute phase of infection. Positive results indicate thepresence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

    Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

    Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions,

    including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.

    The COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro

    diagnostic procedures.


    The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible.

    Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious

    source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.


    COVID-19 Antigen Rapid Test Cassette is an immunoassay based on the principle of the double antibody-sandwich technique. The COVID-19

    Antigen Rapid Test Cassette is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal swab and oropharyngeal swab,

    from patients who are suspected of COVID-19 by their healthcare provider.

    During testing, a specimen migrates upward by capillary action. The SARS-CoV-2 antigens if present in the specimen will bind to the antibody

    conjugates. The immune complex is then captured on the membrane by the pre-coated SARS-Co-2 nuclenocapsid protein monoclonal antibody, and a visible colored line will show up in the test line region indicating a positive result. In the absence of SARS-CoV-2 antigens, a colored line will not form in the test line region indicating a negative result.

    To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been

    added and membrane wicking has occurred.


     For in vitro diagnostic use only.

     For healthcare professionals and professionals at point of care sites.

     Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19.

     Do not use after the expiration date.

     Please read all the information in this leaflet before performing the test.

     The test cassette should remain in the sealed pouch until use.

     All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

     The used test cassette should be discarded according to federal, state and local regulations.


    The test cassette contains a membrane strip coated with anti-SARS-CoV-2 nuclenocapsid protein monoclonal antibody on the T test line, and a dye pad which contains colloidal gold coupled with SARS-CoV-2 nuclenocapsid protein monoclonal antibody.

    The quantity of tests was printed on the labeling.

    Materials Provided

     Test Cassette  Extraction Tube

     Sterilized Swab  Dropper Tip

     Extraction Reagent  Work Station

     Package Insert

    Materials Required But Not Provided

     Timer



     Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.

     Once open the pouch, the test should be used within one hour.Prolonged exposure to hot and humid environment will cause product deterioration.

     The LOT and the expiration date were printed on the labeling.


    Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay.

    Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen

    collection is highly recommended due to the importance of specimen quality for generating accurate test results.


    Contact Rebecca Yan

    Email: rebecca@spanbio.com




    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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