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Vstrip Antigen Rapid Test Kit
$89,999.00 – $17,200,000.00
Vstrip – 180 USD FOB – MOQ – 500 box Wholesale
Antigen Rapid Test Kit – COVID-19 – READY TO EXPORT
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 SENSITIVITY
Inactivated SARS-CoV-2 (USA-WA1/2020), gamma-Irradiated: 3.13×102 TICD50/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
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
Quantity | 500 box, 5000 box, 10,000 box |
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