VTRUST COVID-19 Antigen Rapid Test Model: TD-4531 is one of the Covid-19 rapid tests with the highest sensitivity and specificity today:
Sensitivity (PPA): 93.1%, 95% CI: 83% to 97.2%
Specificity (NPA): 99.6%, 95% CI: 97.7% to 99.9%
FAST – ACCURACY – HIGH SENSITIVITY – MEDICAL MINISTRY LICENSED FOR TRADE
|Test Principle||Lateral Flow Chromatographic Immunoassay|
|Target Antigen||SARS-CoV-2 Nucleocapsid Protein|
|Sample Type||Fresh Naspharyngeal Swab Specimen|
|Limit of Detection (LoD)||1.26 x10^2TCID50 per mL|
|Cross-Reactivity & Interferences||Viruses, Bacteria and Interferences tested do not cross-react or interfere|
|Reaction Time||15 minutes|
- Sterile Nasopharyngeal Swabs ×20
- Test Cassette ×20
- Extraction Tube ×20
- Extraction Tube Dripper ×20
- Extraction Buffer ×2
Interpretation of Results
- Test principle: Immunochromatographic say
- Target antigen: SARS-CoV-2 Protein Nucleocapsid
- Sampling type: Nasopharyngeal fluid sample
- Test time: 15 minutes
- Packing: Box of 20 test kits.
- Storage: 2 – 30 degrees C
1. 20 test trays individually packaged.
2. 20 tubes of sample extraction buffer for single use.
3. 20 Sterile cotton swabs to collect samples for testing.
4. 01 copy of the detailed user manual
5. 01 copy of the Quick Start Guide.
Quality control method: In vitro diagnostic biologicals1. Method of sampling oropharyngeal fluid testing.
Sampling should be done by staff of medical facilities. Use the sterile cotton swab provided in the kit to collect a nasopharyngeal sample. Carefully insert the cotton swab into the nostril where the discharge is most abundant under visual inspection. Hold the swab near the septum of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab a few times then remove it from the nasopharynx.
For details on COVID-19 specimen collection, please refer to interim guidance issued by the CDC:
Guidelines for Collection, Handling, and Testing – Clinical Specimens for COVID.
2. Implementation process:
Nasopharyngeal fluid samples should be tested as quickly as possible after sampling
STEP 1. Read the instruction manual carefully before use.
STEP 2. Check the expiration date on each individual test pack or outer box before use. Do not use any test product beyond the expiration date indicated on the label.
STEP 3. Follow the instructions in the IFU of the VTRUST COVID-19 Antigen Rapid Test (Sample: TD-4531) to perform the nasopharyngeal sample step-by-step.
STEP 4. Show results after 15 minutes. In some cases results may be earlier. Do not read results after 20 minutes .