Basic Info.
Model NO.
HCOV017G
Breathing Pattern
None
Animal Anesthesia Machine Control Method
None
Assay Time
5-10 Minutes
Delivery Time
3~5days After Get Payment
Payment
T/T, Western Union, Paypal
Customized
Accpet
Transport Package
Carton
Specification
10Tests/Kit
Trademark
PETX
Origin
Hangzhou
HS Code
38220010
Production Capacity
5000000PCS/Year
Product Description
INTENDED USE
The SARS-CoV2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV2 in human nasal swab specimen.
MATERIALS
Materials Provided - Foil pouches, each contains one test cassettes, and one desiccant bag
- Assay buffer tubes (0.5ml each) with tips
- Disposable Sampling swabs
- Instruction for use
- Positive control swab and negative control swab
- Specimen collection container
- Timer
INTERPRETATION OF RESULTS
- Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.
- *NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
- Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
PERFORMANCE CHARACTERISTICS
1. Sensitivity, Specificity and AccuracyThe SARS-CoV2 Antigen Rapid Test (Nasal Swab) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity
| Method | Gold standard reagent (PCR) | Total Results | ||
| SARS-CoV2 Antigen Rapid Test | Results | Positive | Negative | |
| Positive | 103 | 0 | 103 | |
| Negative | 7 | 100 | 107 | |
| Total Result | 110 | 100 | 210 | |
Relative Specificity: 100% (95%CI:95.56%~100.00%)
Accuracy: 96.67% (95%CI:93.15%~98.51%)
2. Limit of Detection (LOD)
The limit of detection of the SARS-CoV2 Antigen Rapid Test (Nasal Swab) has been studied. The LOD of the test to the SARS-CoV2 N protein is around 100Pg/mL. The LOD of the test to the SARS-CoV2 virus (inactivated) is about 1.4X102 TCID50/mL.
3. Cross-reactivity:
No cross reaction was observed to the SARS-CoV2 Antigen Rapid Test (Nasal Swab) when samples enriched with the following respiratory symptoms relative pathogens.
| Substance | Concentration | Result |
| Coronavirus HCoV-229E | 1X106TCID50/mL | positive |
| Coronavirus HCoV-HKU1 | 1X106TCID50/mL | negative |
| Coronavirus HCoV-OC43 | 1X106TCID50/mL | negative |
| Coronavirus HCoV-NL63 | 1X106TCID50/mL | negative |
| Parainfluenza virus | 1X105TCID50/mL | negative |
| H1N1 Influenza A virus | 1X105TCID50/mL | negative |
| H3N2 influenza A virus | 1X105TCID50/mL | negative |
| H7N9 influenza A virus | 1X105TCID50/mL | negative |
| Influenza B virus | 1X106TCID50/mL | negative |
| Mycoplasma pneumoniae | 1X106CFU/mL | negative |
| Adenovirus | 1X105TCID50/mL | negative |
| Respiratory syncytial virus | 1X105TCID50/mL | negative |
| Enterovirus 71 | 1X105TCID50/mL | negative |
| Mumps virus | 1X105TCID50/mL | negative |
| Measles virus | 1X105TCID50/mL | negative |
| Streptococcus pneumoniae | 1X106CFU/mL | negative |
| Bordetella parapertussis | 1X106CFU/mL | negative |
| Mycobacterium tuberculosis | 1X106CFU/mL | negative |
The following compounds and other respiratory symptoms relative virus have been tested using the SARS-CoV2 Antigen Rapid Test (Nasal Swab) and no interference was observed.
| substance | concentration | result |
| alpha-interferon | 3millionIU | No interference |
| Purified Mucin | 1000ng/mL | No interference |
| Whole Blood | 20μg/mL | negative |
| Budesonide Nasal Spray | 200μL/mL | negative |
| 1.0mg/mL | negative | |
| Oxymetazoline | 1.0mg/mL | negative |
| HAMA | 1.0mg/mL | negative |
| Fluticasone propionate | 0.5mg/mL | negative |
