The kit can be stored at room temperature or refrigerated (2-30°C). The Test Strip is stable through the expiration date printed on the sealed pouch. The Test Strip must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. The stability of the kit under these storage conditions is 18 months

SPECIMEN COLLECTION AND PREPARATION

The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) (Whole Blood/Serum/Plasma) can be performed using whole blood. Both Fingerstick Whole Blood and Venipuncture Whole Blood can be used.

To collect Fingerstick Whole Blood specimens:

•Wash the patient’s hand with soap and warm water or cleanwith an alcohol swab. Allow to dry.

•Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle orring finger.

•Puncture the skin with a sterile lancet. Wipe away the firstsign of blood.

•Gently rub the hand from wrist to palm to finger to form arounded drop of blood over the puncture site.

•Add the specimen to the test device by using a dropper ormicropipette measuring 10-100uL range.

Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.

Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. For long term storage, specimens should be kept below -20°C.Whole blood collected by Fingerstick should be testedimmediately.

Bring specimens to room temperature prior to testing. Frozenspecimens must be completely thawed and mixed well prior totesting. Specimens should not be frozen and thawed repeatedly formore than three times.

If specimens are to be shipped, they should be packed incompliance with local regulations covering the transportation ofetiologic agents.

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.Bring the pouch to room temperature before opening.Remove the test device from the sealed pouch and use it assoon as possible.

2.Place the test device on a clean and horizontal surface.

A.For Serum or Plasma Specimens:

Use a capillary dropper or a pipette to collect the serum orplasma. Use the capillary dropper to transfer 10 drops(approximately 100 μL) of the specimen into the specimenwell (S) of the test device. Start the timer. Avoid trapping airbubbles in the specimen well (S).

B.For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a capillary dropper: Hold the dropper vertically ontothe puncture site, and transfer 5 drops of whole blood(approximately 50 μL) into the specimen well (S) of the testdevice, then add 3 drops of buffer (approximately 90 uL) andstart the timer. See illustration below.

To use a micropipette: Pipet and dispense 50 μL of wholeblood to the specimen well (S) of the test device, then add 3drops of buffer (approximately 90 μL) and start the timer. Seeillustration below.

*The serum/plasma way is the best way to detect theneutralizing antibodies in blood. But in this kit, we providedalso the materials to carry the whole blood way. It is stronglysuggested to use the serum or plasma to repeat the assay ifthere is doubt with the result obtained by whole blood.

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

INTERPRETATION OF RESULTS

-Positive (+): Only C line appears, or T line is equal to C line orweaker than C line. It indicates that there are SARS-CoV-2neutralizing antibodies in the specimen.

-Negative (-): Both the T line and C line appear, when theintensity of T line is stronger than C line. It indicates that thereis no SARS-CoV-2 neutralizing antibodies in the specimen, orelse the titer of SARS-CoV-2 neutralizing antibodies are of very low level.

-Invalid: Control line fails to appear. Insufficient specimenvolume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure andrepeat the test with a new test. If the problem persists,discontinue using the test kit immediately and contact your local distributor.

Expected Results For Vaccination Reference.

The results if carrying COVID-19 vaccination are expected to be like below.

-Before first dose: Negative by rapid test

-3 weeks after first dose: weak or middle positive

-1 week after second dose: middle or high positive

-2 weeks after second dose: middle or high positive

LIMITATIONS

1.The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19Ab) is for in vitro diagnostic use only. This test should be usedfor the detection of neutralizing antibodies to SARS-CoV-2 or itsvaccines in whole blood, serum, or plasma.

2.The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19Ab) will only indicate the presence of neutralizing SARS-CoV-2antibodies in the specimen and should not be used as the solecriterion for the antibody titer detection method.

3.In the recovered patients, the titer of SARS-CoV-2 neutralantibodies concentrations may be above detectable levels. Thepositive of this assay could not be considered as a successfulvaccination program.

4.The continued presence or absence of antibodies cannot be usedto determine the success or failure of therapy.

5.Results from immunosuppressed patients should be interpretedwith caution.

6.As with all diagnostic tests, all results must be interpretedtogether with other clinical information available to the physician.