Ordering Information

Product Name                                                    Pack Size                                    Catalog No.

Advantage Malaria PAN+Pf Card                       50 Tests                                         IR231050

Brand                                                                                          J MITRA & CO PVT LTD

Test Kit Type:                                                                             Rapid Test Kit

Detects:                                                                                       P.f. (HRP-2) and PAN(pLDH)

Sensitivity:                                                                                  100%

Specificity:                                                                                  99.80%

Intended Use

Advantage Malaria PAN+Pf Card is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of infection with P.falciparum and other Plasmodium species (P.falciparum/P.vivax/P.malariae/P.ovale) in human whole blood only.

Salient Features

Detects P.f. (HRP-2) and PAN(pLDH)

Individually pouched Single tests- Practical & Safe

Infection free- See through Device

Easy to perform test

Easy to interpret Colour bands

Results within 20 minutes

Sensitivity of 100% & Specificity of 99.80%

Longer shelf life -30 months, storage at 4-30° C

Principle

Advantage Malaria PAN+Pf Card is an immunoassay based on the “Sandwich” principle. The conjugate contains colloidal gold conjugated to Pf specific monoclonal anti- HRP-2 antibody and monoclonal anti-pan specific pLDH antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) & monoclonal anti-pan specific pLDH antibody (test line P) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed. If the sample contains P.falciparum or P.vivax/P.malariae/P.ovale, the colloidal gold conjugate complexes the Pf specific HRP-2/ Pan specific pLDH in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.

Evaluations

(i) WHO Evaluation:

The Advantage Malaria PAN+Pf Card test kit has been evaluated by WHO, Geneva using a panel of wild & cultured malaria positive sample and the results obtained are as follows:

                                               Panel Detection Score*                          Specificity*

200 Parasites                         84.0%(P.f) and 100.0%(P.v)                       –

2000 Parasites                       100.0%(P.f) and 100.0%(P.v)                     –

Negative Samples                                      –                                             100 %*

*Reference : Malaria Rapid Diagnostic Test Performance: Results of WHO product testing of malaria RDTs: Round 5 (2013), Page:38

Note : The above information is provided for the scientific community, It is not for commercial or promotional purpose

(ii) In-house Evaluation

Analytical Sensitivity: The test can detect parasitemia levels of >50 parasites per µl of blood for P. falciparum (HRP-2), > 100 parasites per µl of blood for P. falciparum (pLDH) & P. vivax . The Advantage Malaria PAN+Pf Card has been evaluated in-house with malaria positive and negative clinical whole blood samples and compared with microscopic examination. The evaluation also included cross-reacting samples; Dengue, Rheumatoid factor, Leptospira, HIV, HCV, HBV, M. tuberculosis, Syphilis, Brucella, Scrub typhus positive samples. The results obtained are as follows:

Sample                                             No. Of Samples tested                                Advantage Malaria PAN+Pf Card               Sensitivity                            Specificity

                                                                                                                                                                 Positive                    Negative

Malaria Negative                                       2010                                                                1                                 2009                              –                                 99.95%

Cross-reacting sample                               64                                                                   0                                   64                               –                                    100

P.falciparum Positive                                 58                                                                  58                                    0                               100                                  –

P.vivax Positive                                         105                                                                  105                                    0                                  –                                  100

Precision : Within-run and between-run precisions have been determined by testing 10 replicates of six specimens : two negative, two weak positive and two moderate positive. The C.V (%) of negative, weak positive and moderate positive samples were within 10% of the time.