Malaria Pf Blood Rapid Test Kit

SUMMARY AND EXPLANATION OF THE TEST

The Malaria Pf Ag Rapid Test is a lateral flow chromatographic immunoassay. The test strip components  consist of: 1) a burgundy colored conjugate pad containing monoclonal anti- pHRP-II antibody conjugated with colloid gold （pHRP II-gold conjugates), 2) a nitrocellulose membrane strip containing a test band (Pf) and a control band (C band). The Pf band is pre-coated with polyclonal anti-pHRP-II antibodies, and the C band is pre-coated with goat anti-mouse IgG.

SPECIFICATION

FEATURES AND BENEFITS

- No need instrument, get results in 15 minutes.

- High Accuracy, Specificity and Sensitivity.

- Easy to read the result,  no equipment is required to process the specimen .

REAGENTS AND MATERIALS PROVIDED

1.Each kit contains 25 test devices, each sealed in a foil pouch with two items inside:

a. One cassette device.
b. One desiccant.

2. 25 x 5 µL mini plastic droppers.

3. Blood Lysis buffer (1 bottle, 10 mL).

4.One package insert (instruction for use).

STORAGE AND SHELF-LIFE

1. Store the test device packaged in sealed foil pouch at 2-30℃(36-86F).Do not freeze.

2. Shelf-life: 24 months from manufacturing date.

ASSAY PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the

specimen well prior to assay once thawed. Blood will be hemolyzed after thawing.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on

a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: Fill in the mini plastic dropper with the blood specimen not to exceed the specimen line as showed in the following image. The volume of the specimen is around 5 µL.

Holding the dropper vertically, dispense all of the specimen into the center of the sample well

making sure that there are no air bubbles.

Then add 3 drops (about 100-150 µL) of Lysis Buffer immediately.

Step 5: Set up timer.

Step 6: Results can be read in 15 to 30 minutes.  It may take more than 15 minutes to have the background become clearer.

Don’t read results after 30 minutes.  To avoid confusion, discard the test device after interpreting the result

INTERPRETATION OF RESULTS

NEGATIVE RESULT: If only the C band is developed, the test indicates that no detectable pHRP-II antigen presents in the specimen. The result is negative.

POSITIVE RESULT: If both C and Pf bands are developed, the test indicates for the presence of pHRP-II antigen. The result is Pf positive.Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

INVALID: If no C band is developed, the assay is invalid regardless of any burgundy color in the Pf band as indicated below. Repeat the assay with a new device.