V-CHEK SARS-COV-2 RAPID AG TEST (IFA)

This kit is used for in vitro qualitative detection of SARS-CoV-2 antigen.

SARS-COV-2 AG RAPID TEST KIT (FLUORESCENCE IMMUNOCHROMATOGRAPHIC)

This kit is used for in vitro qualitative detection of SARS-CoV-2 antigen.

This Kit is a lateral flow immunofluorescent sandwich assay that is used with the immunofluorescence analyzer intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of SARS-COV-2 by their healthcare provider. This test is only for clinical laboratory use or for immediate inspection by medical personnel, not for home testing, and cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by new coronavirus infection, and is not suitable for screening by the general population.

A positive test result needs further confirmation. A negative test result cannot rule out the possibility of infection.

The kit and test results are for clinical reference only. It is recommended to combine the patient’s clinical manifestations and other laboratory tests for a comprehensive analysis of the condition.

This Kit does not differentiate between SARS-CoV and SARS-CoV-2.

This Kit is intended for use by medical professionals or trained operators who are proficient in performing tests using an immunofluorescence analyzer.

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PRINCIPLE OF THE TEST

SARS-CoV-2 IgG/IgM Rapid Test Kit
(Fluorescence Immunochromatographic)

This reagent uses immunofluorescent double-antibody sandwich to legally detect the antigen of novel coronavirus (SARS-CoV-2) in nasopharyngeal swab and oropharyngeal swab samples. During detection, the fluorescent labeled anti-SARS-CoV-2 monoclonal antibody in the labeling pad binds to the SARS-CoV-2 antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography It is captured by the anti-SARS-CoV-2 monoclonal antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a fluorescent color reaction line is formed in the T zone. If the sample does not contain SARS-CoV-2 antigen, a fluorescent color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains SARS-CoV-2 antigen, a fluorescent reaction line will always form in the quality control area (C). The detection card is detected by the matching fluorescent

  • 1. Store at 2°C – 30°C in the sealed pouch up to the expiration date printed on the package, forbidden to store under 2°C and avoid using expired products.
  • 2. The test card is used within 15 minutes after taking out from the foil envelope. Buffer solution are re-capped in time after use.
    • 3. The buffer should be used immediately after dropping into the dropper.
    • 4. MFG date and EXP date: marked on the label. The product will be expired after 12 months.

This Test Kit is applicable to the Immunofluorescence Analyzer CHF100, CHF200, CHF300, CHF400, CHF500, CHF600, CHF800, produced by Dongguan Tronho Medical Technology Co., Ltd.

  1. Collection of nasopharyngeal secretion: Insert the sterile swab into the place where the nasopharyngeal secretions are the most, and rotate the swab close to the inner wall of the nasal cavity 3 times, remove the swab.
  2. Collection of oropharyngeal secretion: Insert the sterile swab from mouth completely into the oropharyngeal swelling, centering on the red part of the throat wall, epicondylosis, and tonsils, wipe and rotate 3 times with moderate force to avoid touching the tongue and remove the swab.
  3. The samples should be used as soon as possible after collected (within half an hour).
  4. Samples should not be inactivated.

INTERPRETATION OF TEST RESULTS

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1. POSITIVE (+):

indicates that both the detection line and the control line detect a fluorescent signal, and the detection line detection value is more than cut-off value, which is interpreted as positive.

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2. NEGATIVE (-):

indicates that the fluorescent signal is detected on the control line, and the detection value of the detection line is less than cut-off value, which is interpreted as negative.

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3. INVALID (F):

indicates that no fluorescent signal is detected or only the fluorescent signal is detected on the detection line, the interpretation is invalid, and the sample should be re-tested as required.