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Vstrip COVID-19 Antigen Rapid Test

For Emergency Use Authorization only
For in vitro diagnostic use only
For prescription use only

Approved by Taiwan Ministry of Health and Welfare in response to emergency public health circumstances.
Approval Number: Case-Speci­c Approval of Disease Control for Manufacture No. 1096813815
 

INTENDED USE

Vstrip COVID-19 Antigen Rapid Test is a rapid in vitro immunochromatographic assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.
The Vstrip COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.


 

WARNINGS AND PRECAUTIONS

  1. For in vitro diagnostic use.
  2. This test has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens.
  3. Directions should be read and followed carefully.
  4. Do not use the kit contents beyond the expiration date printed on the outside of the box.
  5. Do not interchange or mix different lots of Vstrip COVID-19 Antigen Rapid Test.
  6. Do not insert the test dipstick directly into the sampling area (mouth, nasal).
  7. Disregard test results beyond specified time (10 min).
  8. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.4
  9. Use of protective tools are recommended when handling patient samples.4
  10. When collecting a nasopharyngeal swab sample, use the nasopharyngeal swab supplied in the kit. Use of alternative swabs may result in incorrect results.
  11. Dispose of containers and used contents in accordance with local requirements.
  12. Do not reuse kit components.
  13. The test dipsticks must remain sealed in the protective foil pouch until use.
  14. To obtain accurate results, you must follow the Package Insert.
  15. Inadequate or inappropriate specimen collection, storage, and transport may yield false test results. Negative results do not rule out SARS-CoV-2 infection.
  16. The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals.
  17. Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
  18. Seek specific training or guidance if you are not experienced with specimen collection and handling procedures.5,6
  19. Reagents contain sodium azide, which is harmful if inhaled, swallowed or exposed to skin. Contact with acids produces very toxic gas. If there is contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.
  20. Test devices used in a laminar flow hood or in areas with high air flow should be covered during test development to ensure proper sample flow.
  21. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Material Safety Data Sheet (MSDS) located at Vstip com.
 

LIMITATIONS OF THE PROCEDURE

  1. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 viral antigen from the nasopharyngeal swab.
  2. Failure to follow the test procedure may adversely affect test performance and/or invalidate the test result.
  3. Users should test specimens as quickly as possible after specimen collection.
  4. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5 of illness are more likely to be negative compared to a RT-PCR assay.
  5. Results from the Vstrip COVID-19 Antigen Rapid Test should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
  6. Positive test results do not rule out co-infections with other pathogens.
  7. Negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
  8. Negative test result do not rule out SARS-CoV-2 viral infections. Negative results should be confirmed by molecular diagnostics.
  9. Antibodies may fail to detect, or detect with less sensitivity, when SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region.
 

STORAGE INSTRUCTION

  1. The product should be stored at 15-30℃, away from direct sunlight. Reagents and devices must be at room temperature (15–30 °C) when used for testing.
  2. Kit contents are stable until the expiration date printed on the outer box.
  3. The test dipsticks must be kept in the sealed pouch until use.
  4. Do not freeze or overheat the test kit or kit reagents.

Product Specifications

CLINICAL PERFORMANCE




ANALTICAL SENSITIVITY (LIMIT OF DETECTION)




 

CROSS REACTIVITY




INTERFERING SUBSTANCES

Product Documentation