SARS-CoV-2 Antibody Fast Test Kit

FromWuhan HealthCare Biotechnology Co., Ltd.

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.

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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# RP-319

[Sample Type]: Whole blood /Plasma/Serum

[Sample Volume]: 20µL /10µL/10µL

[Detection Method]: Colloidal Gold

[Reaction Time]: 10-15min

[Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL.

[Storage Conditions]: 2^oC ~ 30^oC

[Shelf Life]: 12 months

[CE Mark Registration No.]: RPS/499/2021.

[EC REP.]: CMC MEDICAL DEVICES & DRUGS S.L. C/ Horacio Lengo n18, C.P 29006, Málaga, Spain.

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.

SARS-CoV-2 Antibody Fast Test Kit

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