Vstrip® COVID-19 Antigen Rapid Test
Vstrip® COVID-19 Antigen Rapid Test
Rapid qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal specimens for in vitro diagnostic use.
Specifications
FEATURES
Method: Lateral Flow Immunoassay
Specimen: Posterior Nasopharynx Swab or Anterior Nasal Cavity Swab
Format: Dipstick / Cassette
Detection Time: 10 minutes
Storage Temperature: 15-30℃
ANALYTICAL SENSITIVITY
Inactivated SARS-CoV-2 (USA-WA1/2020), gamma-Irradiated: 3.13×102 TICD50/ml
CERTIFICATION
- ISO 13485:2016
- TFDA_Case-Specific Approval of Disease Control for Manufacture No.1096813815
- INDIA CDSCO Licence to Import Medical Device IMP/IVD/2021/000128
- CE-IVD
- SINGAPORE HSA Provisional Authorization
- Philippines FDA Special Certification
CLINICAL PERFORMANCE
The performance of the Vstrip COVID-19 Antigen Rapid Test for detection of SARS-CoV-2 was established with 148 individual symptomatic patients who were suspected of COVID-19
- Sensitivity: 90.6 (PPA) (95%CI: 74.98% – 98.02%)
- Specificity: 99.1% (NPA) (95%CI: 95.29% – 99.98%)
- Accuracy: 97.3% (95%CI: 93.22% – 99.26%)
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.
Features & Benefits
NO CROSS REACTIVITY
No cross-reactivity or interference was seen when tested at the 15 viruses and 12 bacteria.
NO INTERFERENCE
29 Nasal spray products and common chemicals were evaluated and no
NO HOOK EFFECT
Variant Detection
Proven and predictive for SARS-CoV-2 variants.
Virus 60 seconds Inactivation
Proven virus inactivation function of Vstrip Extraction Buffer in 60 seconds prevents contamination during assay procedure.
Validated clinical performance of anterior nasal cavity and posterior nasopharynx specimen provides flexibility for specimen collection.
Comparator nasopharyngeal Swab
Anterior nasal cavity swabbing provide an easier solution for self or home testing, which reduces loading of the first line medical personnel and cross infection when going out for testing.
The performance of the Vstrip COVID-19 Antigen Rapid Test for detection of SARS-CoV-2 was established with 162 nasopharyngeal specimens from 148 patients who were suspected of COVID-19 using a US FDA Emergency Use Authorized comparator molecular (RT-PCR) test. As with all antigen tests, performance may decrease as days since symptom onset increases.
A sensitivity of 95.2% for individuals suspected of COVID-19 within the first 5 days of the onset of symptom.
