SARS-CoV-2 Antibody Fast Test Kit.
SARS-CoV-2 IgM/IgG Duo Test Fast Test Kit. CE Marked
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
Ø Coated with carefully selected specific Nucleocapsid and Spike protein antigen.
Ø Detection for IgM and IgG antibodies simultaneously.
Ø Simple operation, easy result interpreted.
Ø Rapid test within 15 minutes.
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]: 2oC ~ 30oC
[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.
Ordering Information
E-mail: cs@healthcare-bio.com; bd@healthcare-bio.com
Tel: +86 027 655 22 983; Mob: +86 18707 111804