Rapid Malaria Self Home Testing Kits Strip Format Detect Plasmodium Falciparum

Personal use Malaria pf Home Testing kits, individual package, detecting antigen of Plasmodium falciparum in remote

Product Name: Malaria pf Home Testing kits


INTENDED USE: The Malaria P.f. Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum in whole blood.

Summary

Malaria is caused by a protozoan which invades human red blood cells. Malaria is one of the world's most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants, young children. Over half of the world's population lives in malarious areas. Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century. The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology. The Malaria P.f. Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P.f. antigen.

TEST PRINCIPLE

The Malaria P.f. Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f. antigen in whole blood. The membrane is precoated with P.f. antibody. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated in the Test Device. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with P.f. antibody on the membrane on the test line. If the specimen contains P.f. antigen, a colored line will appear in the test region. The absence of the colored line in test region indicates that the specimen does not contain P.f. antigen. To serve as a procedure control, a colored line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on room temperature range of 15 - 30°C. If your room temperature is significantly lower than15 °C, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the test region (T).

*NOTE: The intensity of the color in the test line region (T) may vary depending on the concentration of P.f. present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new Test Device. If the problem persists, discontinue using the test kit immediately and contact your local distributor. QUALITY

Performance Study

Sensitivity

The Malaria P.f. Rapid Test Device (Whole Blood) has been tested with thin or thick blood smears on clinical specimens. The results show that the sensitivity of the Malaria P.f. Rapid Test Device (Whole Blood) is >99.0% relative to blood smears.

Specificity

The Malaria P.f. Rapid Test Device (Whole Blood) uses an antibody that is highly specific for Malaria P.f. antigen in whole blood. The results show that the specificity of the Malaria P.f. Rapid Test Device (Whole Blood) is 99.7% relative to blood smears.

Relative Sensitivity: >99.0% (91.8%-100.0%)*

Relative Specificity: 99.7% (98.3%-100.0%)*

Accuracy: 99.7% (98.5%-100.0%)*

* 95% Confidence Interval