The COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in human serum, plasma or whole blood.
SUMMARY AND PRINCIPLE OF THE ASSAY
Coronavirus (CoV) belongs to order Nidovirales, family Coronavirus, and is divided into α、β、γ three genera. The α、β genera is only pathogenic to mammals, while the γ genus mainly causes infection in birds. CoV is mainly transmitted by direct contact with secretions, by aerosol or droplet, and there is also evidence that it can be transmitted by fecal-oral route.
So far, there have been seven types of human coronavirus (HCoV) that cause respiratory diseases in humans: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV-2 is an important pathogen of human respiratory tract infection. Among them, the SARS-CoV-2 by wuhan viral pneumonia cases were found, the clinical manifestation of systemic symptoms such as fever, fatigue, dry cough, dyspnea, etc., can rapidly develop severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock and multiple organ failure, severe alkali metabolic disorders, etc., and even life threatening.
1) Pouch contents:Test cassette, desiccant.
2) Sample buffer (5ml) per bottle for 25 tests
3) Test instruction.
2) Alcohol wipe
1) Suitable for human serum, plasma or whole blood samples, including those prepared by clinical anticoagulants (EDTA, heparin, sodium citrate).
2)Test specimens as soon as possible after collecting. Store specimens at 2°C to 8°C if not tested immediately. Store serum and plasma specimens at 2°C to 8°C up to 5 days. The specimens should be frozen at -20°C for longer storage. Avoid multiple freeze-thaw cycles. Whole blood specimens should be stored in refrigeration (2°C-8°C) if not tested immediately. The specimens must be tested within 24 hours of collection.
3)Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
4)Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.
1) Bring the specimen and test components to room temperature（15～30 ℃） if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
2) When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
3) Be sure to label the device with specimen’s ID number.
4) Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 10 µL of specimen into the sample well making sure that there are no air bubbles.
5) Then add 2 drops (about 70-100 µL) of Sample Diluent immediately.
6) Set up timer.Results can be read in 15 minutes.
Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result.