ES CN EN
Current location:Home Product Center POCT Respiratory Disease
Introduction
Product Features
Specification
Q&A
Video
SARS-CoV-2 Antigen Test Cassette
Detection of SARS-COV-2 Virus in Nasal Swab or Saliva Specimens
The SARS-CoV-2 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens in nasal swab and saliva specimens from human. The test is intended to aid in the rapid differential diagnosis of SARS-CoV-2 viral infection.
Product manual
Download Browse
Introduction
Product Features
Specification
Q&A
Video
Introduction

The SARS-COV-2 Antigen Rapid Test is a qualitative detection of SARS-COV-2 virus in nasal swab or saliva specimens, the virus can be detected within the first week of the onset of symptoms. The test strip is composed of the following parts: sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2. The reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device.


Introduction More
Product Features
Specification
Product Name
SARS-CoV-2 Antigen Test Cassette
Package Specification
1Test/Pack 20Test/Pack
Storage Condition

Store at 4-30°C in the sealed pouch until the expiration date printed on the package. Do not freeze.


Performance

1. Sensitivity, Specificity and accuracy

The SARS-CoV-2 Antigen Test Cassette was compared with a commercially available gold standard reagent (PCR), the results showed that the clinical sensitivity and specificity.

Nasopharyngeal Swab:

Clinical Sensitivity (Positive coincidence rate):98.31% (95% CI: 94.00% ~99.50%)

Clinical Specificity (Negative coincidence rate):99.17% (95% CI: 95.50%~99.90%)

Nasal Swab:

Clinical Sensitivity (Positive coincidence rate):97.30% (95% CI: 93.30% ~99.90%)

Clinical Specificity (Negative coincidence rate):99.19% (95% CI: 96.00%~99.90%)

Saliva Specimen:

Clinical sensitivity (Positive coincidence rate):94.31% (95%CI: 88.72%~97.22%)

Clinical specificity (Negative coincidence rate):100.00% (95%CI: 96.90%~100.00%)


German Instruction for use link:

DE_R220_BMA5680501_IFU_SARS-CoV-2 Antigen Test Cassette_Ver1.0_For Professional Use_20211208.pdf

Performance and stability report:

SARS-Cov-2 Antigen Test Cassette_Stability Report.pdf

SARS-Cov-2 Performance Study Report.pdf


Q & A
Video
You may be interested in: