Coronavirus (COVID-19) Test
Qualified coronavirus (COVID-19) Tests is affordable, high sensitivity, high specificity, user friendly, equipment free, with CE mark, used in labs, hospitals, examination center for fighting again Coronavirus.
Note: Products not for sale or use in the United States. For export only.
Products Type 1:
2019-nCoV Antigen Rapid Test (Colloidal Gold)
Intended Use
This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human throat swabs or nasal swabs or Saliva.
Specification
★ High Sensitivity and Specificity, suitable for early stage detection
★ Fast Reaction: 20 minutes
★ CE mark
Performance
| 2019-nCoV Antigen Rapid Test | PCR Test | Total | ||
| Positive | Negative | |||
| Positive | 74 | 2 | 76 | |
| Negative | 6 | 238 | 244 | |
| Total | 80 | 240 | 320 | |
Analysis of coincidence rate of 2019- nCoV Antigen rapid test and PCR Test in nasal samples:
Positive coincidence rate (Sensitivity):
74/ (74+6) × 100% = 92.5%
Negative coincidence rate (Specificity):
238 / (2+238) × 100% = 99.16%
Total coincidence rate (Accuracy):
(74+238) / (74+6+2+238) × 100% = 97.5%
Ordering Information
| Products | Specimen | Format | Cat. No. | Tests/ kit | Files download |
| 2019- nCoV Antigen Rapid Test (Colloidal Gold) | Swab | Card * | VC012104 | 25 | 1. Inserts 2. EC DOC |
| 2019- nCoV Antigen Rapid Test (Colloidal Gold) | Swab or Saliva | Card * | VC012104-S | 25 | 1(a). Inserts(EN) 1(b). inserts(GE) 2. EC DOC |
*CE marked
Products Type 2:
2019-nCoV antigen and Flu A/B combo Rapid Test
Intended Use
The 2019- nCoV Antigen rapid test is used for in vitro qualitative detection of the antigen of novel coronavirus in human throat swabs or nasal swabs.
The Flu A/B rapid Test is a colloidal gold enhanced, rapid immunoassay for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens. The test is intended for healthcare professional use only.
Specification
★ High Sensitivity and Specificity, suitable for early stage detection
★ Fast Reaction
★ CE Marked
Performance
For 2019- nCoV Antigen rapid test
| 2019-nCoV Antigen Rapid Test | PCR Test | Total | ||
| Positive | Negative | |||
| Positive | 74 | 2 | 76 | |
| Negative | 6 | 238 | 244 | |
| Total | 80 | 240 | 320 | |
Analysis of coincidence rate of 2019- nCoV Antigen rapid test and PCR Test in nasal samples:
Positive coincidence rate (Sensitivity): 74/ (74+6) × 100% = 92.5%
Negative coincidence rate (Specificity): 238 / (2+238) × 100% = 99.16%
Total coincidence rate (Accuracy):
(74+238) / (74+6+2+238) × 100% = 97.5%
For Flu A/B rapid Test
Flu A Sensitivity and Specificity
| Flu A Rapid Test | PCR Test | Total | ||
| Positive | Negative | |||
| Positive | 163 | 16 | 179 | |
| Negative | 12 | 990 | 1002 | |
| Total | 175 | 1006 | 1181 | |
Positive coincidence rate (Sensitivity): 163/ (163+12) × 100% = 93.14%
Negative coincidence rate (Specificity): 990/ (16+990) × 100% = 98.41%
Total coincidence rate (Accuracy):
(163+990) / (163+12+16+990) × 100% = 97.63%
Flu B Sensitivity and Specificity
| Flu B Rapid Test | PCR Test | Total | ||
| Positive | Negative | |||
| Positive | 195 | 15 | 210 | |
| Negative | 12 | 1050 | 1062 | |
| Total | 207 | 1065 | 1272 | |
Positive coincidence rate (Sensitivity): 195/ (195+12) × 100% = 94.20%
Negative coincidence rate (Specificity): 1050/ (15+1050) × 100% = 98.59%
Total coincidence rate (Accuracy):
(195+1050) / (195+12+15+1050) × 100% = 97.87%
Ordering Information
| Products | Specimen | Format | Cat. No. | Tests/ kit |
| 2019-nCoV antigen and Flu A/B combo Rapid Test | swab | Card | VC012106 | 25 |
| * CE marked | ||||
Products Type 3:
Diagnostic Kit for SARS-CoV-2 Ag
(Fluorescence Immunochromatographic Assay)
Intended Use
The kit is used for in vitro qualitative detection of SARS-CoV-2 antigenin human nasopharyngeal swabs and oropharyngeal swabs samples..
Specification
★ High Sensitivity and Specificity, suitable for early stage detection
★ Fast Reaction
★ CE Mark
Performance
- Site 1 (Oropharyngeal swab eluted with matched sample extraction solution)
| CT values | Number of samples | 2019 nCoV RT-PCR Results | Sure Biotech SARS-CoV-2 antigen test result as compared to RT-PCR |
| ≤30 | 57 | pos | 57/57=100% |
| ≤33 | 82 | pos | 82/82=100% |
| ≤34 | 91 | pos | 90/91=98.90% |
| ≤36 | 149 | pos | 136/149=91.28% |
| ≥40 | 45 | neg | 44/45=97.78% |
- Site 2 (Nasopharyngeal swab/Oropharyngeal swab kept in UTM)
| CT values | Number of samples | 2019 nCoV RT-PCR Results | Sure Biotech SARS-CoV-2 antigen test result as compared to RT-PCR |
| ≤25.1 | 52 | pos | 52/52=100% |
| ≤34.8 | 82 | pos | 77/82=93.9% |
| >40 | 45 | neg | 45/45=100% |
Due to sampling deviations, differences in the infection progress for patients, and operational deviations, these data are only responsible for the results of respective clinical trials.
A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly.
Ordering Information
| Products | Specimen | Format | Cat. No. | Tests/ kit |
| Diagnostic Kit for SARS-CoV-2 Ag * (Fluorescence Immunochromatographic Assay) | WB/S/P | Card | VC012105 | 25 |
| Immunofluorescence Analyzer) * | VC050101 | |||
| * CE marked |
Products Type 4:
SARS-CoV-2 IgM/IgG Antibody Rapid Test
(Immunochromatography)
Intended Use
Used for the qualitative detection of the antibody IgM/IgG to novel Coronavirus (COVID-19) in human whole blood/serum/plasma.
Specification
★ Sample Volume: 10 μL
★ Fast Reaction: 15 minutes
★ CE certified
Performance
Ordering Information
| Products | Specimen | Format | Cat. No. | Tests/ kit |
| SARS-CoV-2 IgM/IgG Ab Rapid Test | WB/S/P | Panel * | VC012103 | 25 |
| * CE marked |