Dow Gene DNA Testing Company obtained export permits for three in-vitro diagnosis medical devices that help in the diagnosis of
COVID-19.
- MFDS export permit (in-vitro permit No. 20-225)
- European in-vitro diagnostic reagent (CE-IVD) certification
- Registered by Saudi Arabian FDA (SFDA) (Medical Device National Listing Number: ME0000018668SFDAA00001)
Dow QuickFinder™ 2019-nCoV Real time PCR Kitis an in-vitro medical device used to verify infection of coronavirus disease 2019 (COVID-19).
This product utilizes the real-time reverse-transcription PCR method to precisely sort out patients with trace amounts of novel coronavirus (SARS-CoV-2).
- Specification
| Item | Specification |
|---|---|
| Detection target | SARS-CoV-2 (2019-nCoV, COVID-19) |
| Target region | N gene (N1, N2, N3) |
| Detection technology | Real-time RT-PCR |
| Assay type | Singleplex PCR |
| Specimen type | Nasopharyngeal swab/ Oropharyngeal swab/ Sputum |
| PCR run time | 1hr 40min |
| Limit of Detection | 1 copies/μL |
| Clinical Test | Positive Percent Agreement (PPA) : 100% (63/63) (95% CI : 94.31%~100%) Negative Percent Agreement (NPA) : 100% (120/120) (95% CI : 96.97%~100%) |
| Storage condition | (-20 ± 5) ℃ |
| Compatible PCR device | – Applied Biosystems™ 7500 Real-Time PCR System – Applied Biosystems™ 7500 Fast Real-Time PCR System – Bio-Rad CFX96™ Real-time PCR Detection System |
- MFDS export permit (in-vitro permit No. 20-260)
- European in-vitro diagnostic reagent (CE-IVD) certification
Dow QuickFinder™-G 2019-nCoV Real time PCR Kitis an in-vitro medical device used to verify infection of coronavirus disease 2019 (COVID-19).
This product utilizes the real-time reverse-transcription PCR method to precisely sort out patients with trace amounts of novel coronavirus (SARS-CoV-2).
- Specification
| Item | Specification |
|---|---|
| Detection target | SARS-CoV-2 (2019-nCoV, COVID-19) |
| Target region | RdRp gene, E gene, N gene (N1, N2) |
| Detection technology | Real-time RT-PCR |
| Assay type | Singleplex PCR |
| Specimen type | Nasopharyngeal swab/ Oropharyngeal swab/ Sputum |
| PCR run time | 1hr 40min |
| Limit of Detection | 2 copies/μL |
| Clinical Test | Positive Percent Agreement (PPA) : 100% (13/13) (95% CI : 75.3%~100%) Negative Percent Agreement (NPA) : 100% (10/10) (95% CI : 69.2%~100%)) |
| Storage condition | (-20 ± 5) ℃ |
| Compatible PCR device | – Applied Biosystems™ 7500 Real-Time PCR System – Applied Biosystems™ 7500 Fast Real-Time PCR System – Bio-Rad CFX96™ Real-time PCR Detection System |
- MFDS export permit (in-vitro permit No. 20-1163)
- European in-vitro diagnostic reagent (CE-IVD) certification
Dow NETPlex™ SARS-CoV-2 RT-PCR Kit is an in-vitro medical device used to verify infection of coronavirus disease 2019 (COVID-19).
This product utilizes the real-time reverse-transcription PCR method to precisely sort out patients with trace amounts of novel coronavirus (SARS-CoV-2).
- Specification
| Item | Specification |
|---|---|
| Detection target | SARS-CoV-2 (2019-nCoV, COVID-19) |
| Target region | RdRp gene, ORF1ab gene, N gene |
| Detection technology | Real-time RT-PCR |
| Assay type | Multiplex PCR |
| Specimen type | Nasopharyngeal swab/ Oropharyngeal swab/ Sputum |
| PCR run time | 70min |
| Limit of Detection | 8 copies/μL (RdRp gene : 8 copies/μL, ORF1ab gene : 1 copies/μL, N gene : 1 copies/μL ) |
| Clinical Test | Positive Percent Agreement (PPA) : 100% (39/39) (95% CI: 90.97% ~ 100%) Negative Percent Agreement (NPA) : 100% (80/80) (95% CI 95.49% ~ 100%) |
| Storage condition | (-20 ± 5) ℃ |
| Compatible PCR device | – Applied Biosystems™ 7500 Real-Time PCR System – Applied Biosystems™ 7500 Fast Real-Time PCR System – Bio-Rad CFX96™ Real-time PCR Detection System |