INTENDED USE
For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection.
FEATURES
Coated with carefully selected specific Nucleocapsid and Spike protein antigen.
Detection for IgM and IgG antibodies simultaneously.
Simple operation, easy result interpreted.
Rapid test within 15 minutes.
RESULTS INTERPRETATION
Positive:
1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies.
2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody.
3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody.
Negative:
1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative.
Invalid:
1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested.
2. The test result is invalid after 15 min.
CLINICAL PERFORMANCE
- Positive Percent Agreement (PPA) = 91.07% (153/168) (95% CI: 85.70%-94.92%).
- Negative Percent Agreement (NPA) = 95.37% (103/108) (95% CI: 89.53%-98.48%).
- Overall Rates of Agreement (ORA) = 92.75% [(153+103)/ (168+108)] (95% CI: 89.03%-95.52%).
[Product Name]: SARS-CoV-2 IgM/IgG Duo Test
[Product Code]: Cat# FP-319
[Sample Type]: Whole blood /Plasma/Serum
[Sample Volume]: 20L /10L/10L
[Detection Method]: Colloidal Gold
[Reaction Time]: 10-15min
[Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL.
[Storage Condition]: 2oC ~ 30oC
[Shelf Life]: 12 months
[CE Mark Registration No.]: RPS/499/2021.
Supplier: Winhealth medical is an enterprise in the life and health, is a national innovation oriented enterprises, is the national health protection products designated supply production units, is china's leading integrated medical health industry company, has set research and development of science and technology, health, engineering, logistics distribution, international management as one of the major health industry chain.
winhealth medical science and technology research and development with the biotechnology center, research center of traditional chinese medicine.
Supplier: Medical, surgical, industrial and paper products & chemicals
