CorDx

COVID-19 Saliva Ag Test

COVID-19 Saliva Ag Test is used for qualitative detection of the antigen of COVID-19 in human saliva sample.

INTENDED USE

COVID-19 Saliva Ag Test is used for qualitative detection of the antigen of COVID-19 in human saliva sample.

 

INTRODUCTION

CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. Evidence suggests transmission via fecal-saliva route. 7 kinds of HCoVs caused human’s respiratory diseases are found by now: HCoV-229E, HCoV-OC43, SARS -CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and 2019-nCoV which are the serious pathogens for human’s respiratory diseases. Its clinical manifestation are fever, enervate and systemic symptom, with dry cough, difficult breathing etc. and it may aggravate to severe pneumonia, respiratory failure, acute respiratory distress syndrome ,septic shock, multiple organ failure, severe acid-base metabolic disorders etc and even life threatening rapidly.

 

SPECIMEN PREPARATION

Collect the saliva sample using the saliva collector and extraction tube provided. Do not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.

  1. Insert the sponge of saliva collector into the mouth, actively swab the inside of the mouth and tongue to collect oral fluid for approximately 1-2 minutes until the sponge becomes soft and fully saturated.The sponge will be free from hard spots when fully saturated.
  2. Unscrew the top of sample processing solution bottle.
  3. Add 0.2mL (all solutions in the buffer bottle) of the sample processing solution into the extraction tube.
  4. Squeeze the wall of the extraction tube against the sponge by hand, so that the saliva in the sponge of the saliva collector flows into the extraction tube, twist close the whole cap of saliva collector.
  5. Gently shake the extraction tube vertically for about 5 seconds to allow saliva mix well with processing solution.
  6. After 1 minute, the sample can be used for testing.

NOTE: 

  1. Sample size requirements: the correct sample size is within the dotted line, too little sample size or too much sample size is wrong.
  2. Under normal temperature, samples should be processed within 1 hour after collection. If the sample cannot be tested in time after treatment, the processed sample should be refrigerated at 2-8 ℃ and the test should be completed within 12 hours after treatment.
  3. Freezing and thawing of samples is strictly prohibited.

 

TEST PROCEDURE

  1. Remove the test from the sealed pouch. Lay it on a flat, clean and dry surface.
  2. Reverse the sample collection tube, and add 2-3 drops (about 75~100 μL) of test sample by squeezing the collection solution tube into the sample well.
  3. Read results within 10-15 minutes.

 

INTERPRETATION OF RESULTS

Positive: Control line and Test line appear in the show window.

Negative: Only one line appears in Control area, No line appears in T area. Invalid: If no line appears in the control area, the test results are invalid regardless of the presence or absence of line in the test area. The direction may not been followed correctly or the test may be deteriorated. It is recommended that repeat the test using a new device. If the problem persist, please stop to use the product and contact local distributor.