SARS-CoV-2/Human Influenza Virus A&B (Flu A&B)

SARS-CoV-2/Human Influenza Virus A&B (Flu A&B)

Antigen Test Kit( Colloidal Gold)

FEATURES

l Fast result in 15 minute.

l Easy to operate.

l Highly sensitive via visual inspection.

l For SARS-CoV-2, Influenza A, Influenza B virus high-performance pairing.

l Immunoassay is more practical than PCR.

PACKING SPECIFICATION

1Test/Kit, 20 Tests/Kit

REAGENTS PROVIDED

INTENDED USE

This kit is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2,influenza type A and influenza type B in the same time directly from nasal/ nasopharyngeal (NS/NP) swab, oropharyngeal(OP) swab.

TESTING PROCEDURE

1. Open the pouch,Take the Test cassette out from the pouch and place on a well-lit, flat surface.locate the Result window and Specimen well on the cassette.

2.Gently squeeze the tube and dispense 3 drops of solution at a 90o angle to the Sample Well(S) on the test card.

Note: 1).Add the solution drop by drop,and in a vertical manner.

2).A false negative or invalid result may occur if less than 3 drops of fluid are added to the Sample Well.

3.Immediately star timing 15 minutes and wait.

                                                                                                                  Three Drops in the sample wells.                                                        Read result within 15 min.

SPECIMEN COLLECTION 

1. Nasal swab: 

To collect a nasal swab sample, carefully insert the swab into the nostril that presents the most secretion under visual inspection. Using gentle rotation, rotate the swab against the wall of the nostril into the patient's nostril to the nasal palate, and then slowly remove it while wiping.

2. Nasopharyngeal swab:

To collect a nasopharyngeal swab sample, carefully insert the swab into the nostril that presents the most secretion under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times then remove it from the nasopharynx.

3. Oropharyngeal swab:

To collect an oropharyngeal swab sample, tilt the head back slightly, open the mouth wide to expose the tonsils and back of the throat. Carefully insert the swab into the nasal condyle inside the nasal passage, stay for a while (no less than 10 seconds), and slowly turn it out.

SPECIMEN PREPARATION PROCEDURE

1.When the specimen was collected, Immediately place the swab into the tube and swirl for 30 seconds.

Note: A false negative result may occur if the swab is not swirled at least 30 seconds.

2..Rotate the swab 5 times while squeezing the tube.

Note: A false negative result may occur if the swab is not rotated five times

3.Hold the Tube firmly with one hand. Lift the Swab and locate the break line.

4.Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube.

INTERPRETATION OF TEST RESULTS

Positive（+）

1. The presence of ALL T (A or B on Flu) and C lines within the reaction window, regardless of whether which line appears first, indicates a positive result on SARS-CoV-2 or Flu A and/or B infection or co-infection.

Negative（-）

The presence of “C” line (control line) only within the reaction window, no T line and A and/or B line is present, the test result is negative on SARS-CoV-2 and Flu A and/or B.

Invalid

1. If the control(C) line is not displayed in 15 min, regardless of whether T and/or A/B line is present, the test result is invalid. It is recommended that the specimen should be re- tested.

2.The test result is invalid after 15 min.