INTRODUCTION
Vstrip® COVID-19 Antigen Rapid Test is a rapid immunochromatographic assay that utilizes specific monoclonal antibodies to detect the nucelocapsid protein (NP) of SARS-CoV-2 virus in nasopharyngeal swab specimens, producing results in 10 minutes and at approximately 10% the cost of a PCR.
This product comes from the AEP alliance of three biotech companies in Taiwan: AnTaimmu BioMed; EirGenix; Panion & BF Biotech. AnTaimmu BioMed discovered and developed novel monoclonal antibodies against SARS-CoV-2 NP, EirGenix mass-produced GMP certificated antibodies, and Panion & BF Biotech developed and produced the rapid test through their GMP facility.
Taiwan FDA announced its approval of Vstrip® COVID-19 Antigen Rapid Test under Emergency Use Authorization (EUA) on August 27th and this is the FIRST antigen rapid test product approved by Taiwan FDA. Furthermore, the Indian Council for Medical Research (ICMR) announced that it has validated and approved Vstrip® COVID-19 Antigen Rapid Test as satisfactory on September 25th (https://www.icmr.gov.in/ckitevaluation.html). Only 5 antigen rapid tests are approved by ICMR so far and Vstrip® is the first Taiwanese-made antigen rapid test. The CERTIFICATIONs were approved as following: ISO 13485:2016, HSA, CE-IVD, TFDA_Case-Specific Approval of Disease Control for Manufacture No.1096813815.
CLINICAL PERFORMANCE and LIMIT OF DETECTION
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. Test results were compared to FDA Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2. The overall sensitivity and specificity is 90.62% and 98.21%.(PPV: 96.67% NPV: 94.83%)
The limit of detection (LoD) of this Vstrip® is 3.13×102 TCID50/ml for the CGMH virus strain (conducted at Chang Gung Memorial Hospital, Linkou, Taiwan). The cross-reactivity of this Vstrip® was evaluated with 12 bacteria (at a concentration of over 108 CFU/ml) and 15 viruses (at a concentration of over 104 TCID50 /ml) 1, and none of the microorganisms tested gave a positive result.
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 |
PRODUCT DOCUMENTATION
- Material Safety Data Sheet
- ISO 13485 Certificate
- Approval Letter (Taiwan)
- Free Sale Certificate (Taiwan)
- CE Certificate of IVD Notification
- Instruction for Use (CE)
- Instruction for Use (Singapore)
EXTERNAL LINK
Other details about Vstrip could be found here (Provided by Panion & BF Biotech) .
For further inquiries and questions, please contact us by E-mail or phone: +886-3-5797779 Fax:118