Basic Info.

HS Code

3822001000

HS Code

3822001000

Product Desciption

Infectious Disease Rapid Antigen Test Kit, Diagnostic Kit


Specimen Collection
Nasopharyngeal Swab Specimen: Insert sterile sample swab 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 swab tip 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 other nostril.



Oropharyngeal Swab Specimen: Insert swab into the nosterior oharvnx and tonsillar areas. Rub swab over both tonsillar oillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.

SPECIMEN TRANSPORT AND STORAGE
Specimen should be tested as soon as possible after collection. Specimens may be stored at room temperature for up to 1 hours or at 2-8°C/ 36-46°F for up to 4 hours prior to testing.
Test Procedures
Note: Allow the test device and specimens to equilibrate to temperature(15-30ºC or 59-86°F)prior to testing.
1,Procedures for 1 Test/Kit
A. Puncture the sealing film of the extraction tube with the tip of the dripper.
B. Insert the sampling swab into the extraction tube, press the outer wall of the tube with one hand to press the sampling swab, and twist the swab at least 5- 10 times with the other hand.
C. Pull the swab head away from the dilution liquid surface, squeeze out the liquid, to make the solution in the tube as the test specimen, then cover the tube head.
D. Take out the test card from the aluminum foil bag and place it flat on the desktop. Add 2 drops of specimen from the extraction tube to the specimen hole of the test card.
E. Timing, judge the test result after 15~30 minutes.
 

Do not read test results after 30 minutes. It may give false results.

Procedures for 40 Tests/Kit
1. Open the diluent bottle and add 10 drops of diluent to the extraction tube.
2. Insert the sampling swab into the extraction tube, press the outer wall of the tube with one hand to press the sampling swab, and twist the swab at least 5-10 times with the other hand.
3. Pull the swab head away from the dilution liquid surface, squeeze out the liquid, to make the solution in the tube as the test specimen, then cover the tube head.
4. Take out the test card from the aluminum foil bag and place it flat on the desktop. Add 2 drops of specimen from the extraction tube to the specimen hole of the test card.
5. Timing, judge the test result after 15-30 minutes.
Do not read test results after 30 minutes. It may give false results.

Interpretation of Results




A total of 179 patient specimens from susceptible subjects were test by the PCR test. Comparison for all subjects is showed in the following table:

Ag	RT-PCR		Total
	Positive	Negative
Positive	53	1	54
Negative	6	119	125
Total	59	120	179

Relative Sensitivity:89.83%; Relative Specificity: 100%;
Overall agreement:96.65 %