STANDARD™ Q COVID-19 IgM/IgG Plus Test
Intended Use
STANDARD Q COVID-19 IgM/IgG Plus Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies(anti-SARS-CoV-2 nucleocapsid(N) protein antibodies and anti-SARS-CoV-2 Spike RBD antibodies) to SARS-CoV-2 present in human serum, plasma or whole blood.
This test is for in vitro professional diagnostic use and intended as an aid to diagnosis of SARS-CoV-2 infection in convalescent phase of patient with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2 infection.
Advantage
- Getting a fast result in 10 ~ 15 minutes
- Easy handling which does not require specific training
- Suitable for Point Of Care Testing
- No follow-ups or equipments required
- Video guide provided (soon)
- External quality control available(option)
Additional information
| Test time | 10 ~ 15 minutes |
|---|---|
| Specimen | Whole blood, Serum, Plasma |
| Specimen volume | Whole blood(20μl), Serum(10μl), Plasma(10μl) |
| Sensitivity | 99.03%(102/103) |
| Specificity | 98.65%(219/222) |
| Storage temperature | 2-30℃/36-86℉ |
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