SARS-CoV-2 Antigen Fast Test Kit.
SARS-CoV-2 Antigen Fast Test Kit. CE Marked
INTENDED USE
For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection.
FEATURES
Ø Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2.
Ø Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva.
Ø Easy to use, easy results interpretation by naked eyes.
Ø Test result available within 15minutes.
CLINICAL PERFORMANCE
- LoD: 1.5×102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen.
- Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable.
- No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track.
- Positive Agreement (95% CI): 30/31 96.8% (83.3% - 99.9%)
- Negative Agreement (95% CI): 80/80 100.0% (95.5% - 100%).
[Product Name]: SARS-CoV-2 Antigen Test
[Product Code]: Cat# RP-318
[Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva
[Detection Method]: Colloidal Gold
[Reaction Time]: Within 15min
[Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1.
[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