CorDx

Covid Ag Nasopharyngeal swab test

COVID-19 Ag Test is the chromatographic immunoassay test used for qualitative detection of the COVID-19 antigen in human nasopha- ryngeal swab specimens.

INTENDED USE

COVID-19 Ag Test is the chromatographic immunoassay test used for qualitative detection of the COVID-19 antigen in human nasopha- ryngeal swab specimens.

INTRODUCTION

CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. Evidence suggests transmission via fecal-oral route. 7 kinds of HCoVs caused human,s respiratory diseases are found by now: HCoV-229E, CoV-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. The target antigen detected by the Coretests® COVID-19 Ag Test is N protein with high maintenance. The Spike protein is the main mutation site of the UK mutant strain (B.1.1.7) , South African mutant (501.V2) and Brazil mutant (P.1). It has been verified that the virus antigens of these three mutants can be detected by the Coretests® COVID-19 Ag Test.

SPECIMEN PREPARATION

  1. The collection method of nasopharyngeal swab is shown in Figure 4 to 7.
  2. Sample processing: Figure 1.Insert the sample collection tube into the hole of provid- ed box. Make sure that the tube is standing firm and reaches the bottom of the workstation. Figure 2. Unscrew the top of sample processing solution bottle. Figure 3. Add 0.3 mL (all solutions in the buffer bottle) of the sample processing solution into the collection tube. Figure 8. Insert the swab in collection tube to the bottom, rotate and squeeze the swab 10 times while pressing the head against the bottom and side of the collection tube. Figure 9. Leave the swab in the collection tube for 1 minute. Figure 10. Rotate and squeeze the tube several times with fingers from outside of the tube to unwater the swab. Remove the swab. Figure 11. Screw the cap of collection tube. Figure 12. Shake and mix the retained solution well. The retained solution will be tested with COVID-19 Ag test.

NOTE: 

  1. Please use swab for specimen colletion.
  2. It is highly recommended to collect specimen with wearing a pair of safety gloves to avoid contamination.
  3. Do not touch the tip(specimen collection area) of the swab.
  4. Collect sample as soon as after onset of symptoms.
  5. It is recommended to treat the sample immediately after collec- tion.The sample can be stored at 2℃~8℃ for 72 hours, and it needs to be frozen at -20℃ for long-term storage, avoiding repeated freezing and thawing.

TEST PROCEDURE

Read the instruction first prior to testing. Bring the pouched test to room temperature prior to testing. Do not open the pouch until ready to begin testing.

  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 T 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.