Tri - Line Home Medical Test Kits 95% Accuracy Detecting Malaria PF/PV Antigen

Product Specification

Tri-line Malaria pf/pv antigen Home Testing kits, personal use, 4mm cassette full kit, remote area use

Product Name: Malaria P.f & P.v Home Testing kits

INTENDED USE: The One Step Malaria (p.f/p.v) Cassette Test is a two site sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2 (Pf. HRP-2) and P. vivax specific pLDH. The test can also be used for specific detection and differentiation of P. falciparum and P. vivax malaria.

SUMMARY:

Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P. ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P. falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution1.

Traditionally, malaria is diagnosed by the demonstration of the organisms on Giemsa stained smears of peripheral blood, and the different species of plasmodium are distinguished by their appearance in infected erythrocytes1. The technique is capable of accurate and reliable diagnosis, but only when performed by skilled microscopists using defined protocols2, which presents major obstacles for the remote and poor areas of the world.

TEST PRINCIPLE

A capture monoclonal antibody is immobilized on the membrane within the cassette. The red blood cells are lysed releasing Pf. HRP11 and P. vivax specific pLDH which binds selectively to this antibody as the blood flows along the strip inside the cassette. The signal reagent is coated with specific antibodies, which bind with the antibody-antigen complex, producing a black line. The presence of an upper black line (the control line) demonstrates the test has been performed correctly.

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.Dispense 1 drop (10µl) of whole blood to the “S” well of the test cassette using the plastic pipette provided, according to the illustrations below.

4. Add three drops of Sample Diluent to the “D” well after the specimen is added and absorbed.

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

Malaria P.f Positive
The control line and Malaria P.f line (T1) are visible in the result window. The test is positive for Malaria P.f.

Malaria P.v Positive
The control line and Malaria P.v line (T2) are visible in the result window. The test is positive for Malaria P.v.

Malaria P.f and Malaria P.v Positive

The control line, Malaria P.f (T1) and Malaria P.v (T2) lines are visible in the result window. The test is positive for Malaria P.f and Malaria P.v.

Negative

The control line is the only line visible in the result window. No Malaria P.f or Malaria P.v has been detected.

Invalid
If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Performance Study

The following data was generated from previously frozen whole blood samples and was determined by correlation to standard thick and thin smear microscopic examination with discrepancies evaluated via PCR. Retrospective study results are summarized below: