Antigen Rapid Test Kit (ARTRON)

COVID-19 Antigen Rapid Test Kit

Product characteristics

Artron COVID-19 Antigen Test is a rapid and convenient immuno-chromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasopharyngeal swab obtained from patient with signs and symptoms of respiratory infection. The test kit is designed to aid in the rapid diagnosis of COVID-19 Virus infection. This assay is not intended to be used for screening patients or as an aid for diagnosis of patients with suspected COVID-19 Ag infection, this assay is not intended for home testing (or self-testing). The results should be confirmed by Real-Time Reverse Transcriptase (RT)-PCR Diagnostic kit; they do not preclude COVID-19 Virus infection and should not be used as the sole basis for treatment or other management decisions.

  1. Nasopharyngeal Swab
  2. Simple: Easy to perform, Solid phase (Collodial Gold) Immunochromatographic assay.
  3. Qualitative membrane-based immunoassay (Colloidal Gold). A colored line will appear in the respective line region. Test is positive if the control line and the antigene line shows up.

The test is intended for medical professional and laboratory use.

Indication for Testing

  1. To detect infection after contact with COV-2 infected persons
  2. At or before onset of symptoms in addition to PCR test.
  3. As a precaution before meeting third party
  4. If no PCR test is accessible.
  5. As a precaution in case of uncertainty if infection took place.
  6. As a follow up after being PCR positive tested, to monitor the status if potentially still infective.

Specifications

  1. Sensitivity: 91.27%
  2. Specificity: 100% (with 95% confidence interval 99.22% – 100%)

Order Number: S-CoV-2-AGRT (Kit with 25 tests)
Price:  From 3,50€ per test

1) Clinical Site 1: Ahmedabad, Gujarat, INDIA
Clinical Site 2: Santa Ana Hospitals, Manila, PHILIPPINES

NoContentQuantity
1Instructions for use1 copy
2Test cassette25 cassettes
3Reagent solution bottle1
4Reagent tube25
5Sterilized Nasopharyngeal Swab25
Product NameSample TypeStorage TemperaturePackaging Size
COVID-19 Antigen Rapid
Test Kit
Nasopharyngeal
swab sample
Store at 2°C -8°C96 Tests / Kit

Specimen Collection

1

Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.

2

Swab over the surface of the posterior nasopharynx.

3

Withdraw the sterileswab from the nasal cavity.

Test Procedure

A

Add 400ul extraction buffer (approximately 12 drops) into the reagent tube.

B

Add Nasopharyngeal swab to the tube with extraction buffer.

C

Vigorously rotate and twist the swab against the side of the tube at least 10 times.

D

Squeeze the sides of the tube to obtain as much as liquid as possible. Dispose the swab properly.

E

Apply the cap to the tube with specimen, an hold the tube verticaly, add 5 drops (about 120 µl) of the specimen without air bubbles into the sample well.

Result Interpretation

Negative:

A pink colored band appears only at the control region (C), indicating a negative result for COVID-19 Infections.

Positive:

A clear pink control band (C) and a detectable test band (T) appears, indicating a positive result for COVID-19 infections.

Invalid:

No visible band appears at the control region. Repeat with a new test kit. If the test still fails, please contact the distributor with the lot number.