Home > Products > Detail
RESPIRATORY DISEASES

Vstrip® COVID-19 Antigen Rapid Test

Rapid qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal specimens for in vitro diagnostic use.

Product Specifications

FEATURES

Method: Monoclonal immunochromatographic assay

Specimen: Nasopharyngeal swab

Detection device: Dipstick

Time to Result: 10 minutes

Storage temperature: 15-30℃

 

CLINICAL PERFORMANCE

The performance of the Vstrip COVID-19 Antigen Rapid Test for detection of SARS-CoV-2 was established with 88 individual symptomatic patients who were suspected of COVID-19

  • Sensitivity: 90.62%  (PPA) (95%CI: 74.98% - 98.02%)
  • Specificity: 98.21%  (NPA) (95%CI: 90.45% - 99.95%)
  • Accuracy: 95.45%    (95%CI: 88.77% - 98.75%)
  • Positive predictive value: 96.67%    (95%CI: 80.56% - 99.51%)
  • Negative predictive value: 94.83%   (95%CI: 86.19% - 98.18%)
  

ANALYTICAL SENSITIVITY

Inactivated SARS-CoV-2, gamma-Irradiated: 3.13x102 TICD50/ml

SARS-CoV-2 recombinant nucleocapsid protein:  30 ng/ml

  

ANALYTICAL SPECIFICITY

The cross reactivity study was evaluated with a total of 12 bacteria strains and 15 viruses strains. None of these tested microorganisms gave a positive result

  

CERTIFICATION

ISO 13485:2016

CE-IVD

TFDA_Case-Specific Approval of Disease Control for Manufacture No.1096813815
 

Features & Benefits

Feature Benefit
Dipstick Have less operation steps
Results in 10 minutes Enable immediate treatment within minutes
Differential color results Offer easier interpretation and accurate reading
Built-in internal controls Verify proper procedure and test device function
Room temperature storage Save space, time and cost : No need for refrigeration and warming up