Malaria Pf Pv Rapid Diagnostic Test Kit

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 three 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℃. 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 shown 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 20 to 30 minutes. It may take more than 20 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

1. NEGATIVE RESULT: If only the C band is present, the absence of any burgundy color in the both test bands (Pv and Pf) indicates that no anti-plasmodium antigens are detected.  The result is negative.

2. POSITIVE RESULT:

2.1In addition to the presence of C band, if only Pv band is developed, the test indicates for the presence of Pv-LDH antigen. The result is Pv positive.

2.2 In addition to the presence of C band, if only Pf band is developed, the test indicates for the presence of pHRP-II antigen. The result is Pf positive.

2.3In addition to the presence of C band, both Pv and Pv bands are developed, the test indicates for the presence of both Pv-LDH and pHRP-II antigens. The result is both Pv and Pf positive.

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