One Step strip Style ANTI-HP in Whole Blood Test

INTRODUCTION

One Step ANTI-HPin Whole Blood Rapid ScreenTest is a chromatographic immunoassay for the qualitative detection of antibodies to HP in human whole blood. Two Purified recombinantantigens of HPare used in test band as capture materials and gold conjugates. If the antibodyof Anti-HP is present in the sample inconcentration above the labeled,complex willbe formed. This complex is then captured by antigens immobilized in the Test Zone of the membrane,producing a visible pink-rose color band on the membrane. The color intensity will depend on theconcentration of the anti-HP present in the sample. This one step test is very sensitive and only takesabout 15 minutes. Test results are read visually without any instrument.

SPECIMEN COLLECTION

For whole blood, collect blood into a container with anticoagulant(EDTA or heparin ).

Use the specimen inside an hour.If the specimen can not be tested inside an hour, store the specimen in 4℃cold closet or refrigerator,but Don’t freeze. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

TEST PROCEDURE

  1. To begin testing; open the sealed pouch by tearing

along the notch. Remove the test from the pouch.

  1. lay the strip flat on a clean, dry, nonabsorbent surface ,draw 30ul whole blood into the sample pad.
  2. Then draw one drop of buffer into the sample pad as well.

4.Wait for colored bands to appear.Read resultswithin 15 minutes. Do notread results after 20 minutes.

INTERPRETATION OF RESULTS

  1. Negative: Only one color band appears on the control region. No band appears on the test region. This indicates that there isno detectable anti-HP inthe sample.

2.Positive: Distinct color bands appears on the controland regionstest. Both test line and control line indicatethat the specimen contains detectable amount ofanti-HP.

3.Invalid: No visible bang at all or only one colored band appears on test region, this is an indication of a possible error in performing the test. The testshould be repeated using a new device.

PRECAUTION:

1、Must use fresh specimen, the specimen is only valid for three days after collection.

2、Use it before expiry date.

3、The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.

LIMITATIONS

1、The test is for in-vitro diagnostic use only.

2、The test is qualitative filter detection，it can not be used as the final test for blood donor

STORAGE AND STABILITY

The test kit can be stored at room temperature (2 to 30C) in the sealed pouch to the date of expiration.The test kit should be kept away from direct sunlight, moisture and heat.