Sars-CoV-2 Antigen Rapid Test (POCT)

INTENDED USE

The SARS-CoV-2 Antigen Rapid Test (POCT) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human nasopharyngeal, oropharyngeal and nasal specimen.

MATERIALS

Materials Provided

• Foil pouches, each contains one test cassettes, and one desiccant bag
• Assay buffer tubes (0.5ml each)with tips
• Disposable Samplingswabs
• Instruction for use
• Positive control swab and negative control swab

Materials Required But Not Provided

• Specimen collection container
• Timer

• TEST PROCEDURE

  Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing. Run a quality control testing before using the kit (if necessary) according to the quality control protocols.

  1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
  2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.

  See illustration below.

   

  3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

  INTERPRETATION OF RESULTS

   

  • Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.

  *NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.

  • Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
  • Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
  • 1. Sensitivity, Specificity and Accuracy

    The SARS-CoV-2 Antigen Rapid Test (POCT) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

    • Nasopharyngeal swab

    Method		Gold standard reagent (PCR)		Total Results
    SARS-CoV-2 Antigen Rapid Test (POCT)	Results	Positive	Negative
    	Positive	115	0	115
    	Negative	2	200	202
    Total Result		117	200	317

    Relative Sensitivity: 98.29% （95%CI: 93.60%～99.91%）  

    Relative Specificity: 100% （95%CI：97.73%～100.00%） 

    Accuracy: 99.37% （95%CI：97.58%～99.98%）

    • Oropharyngealswab

    Method		Gold standard reagent (PCR)		Total Results
    SARS-CoV-2 Antigen Rapid Test (POCT)	Results	Positive	Negative
    	Positive	124	0	124
    	Negative	7	200	207
    Total Result		131	200	331

    Relative Sensitivity: 94.66% （95%CI: 89.19%～97.58%）  

    Relative Specificity: 100% （95%CI：97.73%～100.00%） 

    Accuracy: 97.89% （95%CI：95.61%～99.06%）