Materials Provided

 Test Cassette Extraction Tube

 Sterilized Swab Dropper Tip

 Extraction Reagent Work Station

 Package Insert

Materials Required but Not Provided

 Timer

[STORAGE and STABILITY]

 Store as packaged in the sealed pouch at temperature (4-30℃ or 40- 86℉). the kit is stable within the expiration date printed on thelabeling.

 Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

 the LOT and the expiration date were printed on the labeling.

[SPECIMEN]

Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results.

Sample Collection

Nasopharyngeal Swab Sample

Insert minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the othernostril.

 

Oropharyngeal Swab Sample

Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.

Sample Preparation

after Swab specimens were collected, swab can be stored in extraction reagent provided with the kit. Also can be stored by immersing the swab head in a tube containing 2 to 3 mL of virus preservation solution (or isotonic saline solution, tissue culture solution, or phosphate buffer).

Sample Transport and Storage

Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Specimen collected may be stored at 2-8℃ for no more than 24 hours; Store at -70 ℃ for a long time, but avoid repeated freeze-thaw cycles.

[SPECIMEN PREPARATION]

1. Unscrew the lid of an extraction reagent. Add all of the specimen extraction reagent into an extraction tube, and put it on the work station.

2. Insert the swab sample into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube.Leave the swab in the extraction tube for one Minute.

3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. the extracted solution will be used as test specimen.

4. Insert a dropper tip into the extraction tube tightly.

  

(the picture is for references only, please refer to the material object.)

  [TEST PROCEDURE]

Allow the test device and specimens to equilibrate to temperature (15-30℃ or 59-86℉) prior to testing.

1. Remove the test cassette from the sealed pouch.

2. Reverse the specimen extraction tube, holding the specimen extraction tube upright, transfer 3 drops (approximately 100μL) to the specimen well(S) of the test cassette, then start the timer. See illustrationbelow.

3. Wait for colored lines to appear. Interpret the test resultsat 15 minutes. Do not read results after 20 minutes.

           

(the picture is for references only, please refer to the material object.)

[INTERPRETATION of RESULTS]

 

Positive:*Two lines appear.One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test region (T). Positive for the presence of SARS-CoV-2 nucleocapsid antigen. 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: One colored line appears in the control region (C). No line appears in the test region (T).Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is recommended that these results be confirmed by a molecular testing method, if necessary, for patient management.

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 using a new test cassette. If the problem persists, discontinue using the lot immediately and contact your local distributor.

[QUALITY CONTROL]

A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. however, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.