General Description:
First ResponseŽ Malaria Ag test is a rapid test for the detection of
Malaria lactate dehydrogenase (LDH) in human blood as an aid in the
diagnosis of Malaria infection. It is designed for the differential
diagnosis between Plasmodium falciparum and the other Plasmodium species
Technical Specifications:
The First ResponseŽ Malaria Antigen Test contains a membrane strip,
which is pre-coated with two monoclonal antibodies as two separate lines
across a test strip. One monoclonal antibody (test line 1) is specific
to the lactate dehydrogenase of P. falciparum and another monoclonal
antibody (test line 2) is pan specific to the lactate dehydrogenase of
Plasmodium species (P. falciparum, vivax, malariae, ovale). Conjugate
pad is dispensed with monoclonal antibody, which is pan specific to the
lactate dehydrogenase of Plasmodium species.
Supplied with:
First ResponseŽ Malaria Antigen Test Kit contains the following items to
perform the assay:
30 Test Devices
Assay Buffer
Sample Pipette
30 lancets
30 alcohol swabs
Package insert
Dessicant
Accessories/Spare parts/Consumables (not provided): N/A
Precautions:
In order to obtain reproducible results, the following rules must be
observed:
For in vitro diagnostic use only;
Use disposable gloves while handling potentially infectious material and
performing the assay. Wash hands thoroughly afterwards;
Do not use it beyond the expiration date;
Do not eat or smoke while handling specimens;
Clean up spills thoroughly using an appropriate disinfectant.
Storage conditions:
4ēC - 30ēC. Do not freeze.
Performance characteristics:
Sensitivity: P. falciparum 95%; P. vivax 92%
Specificity: 99.5 %
Considerations for choosing a malaria rapid diagnostic test (RDT)
product include:
The plasmodium species to be detected (P. Falciparum only, or
pan-specific and non-falciparum species);
Shelf-life and temperature stability in intended conditions of storage
and use;
Ease of use, including format of the test (e.g. cassette, dipstick, and
card);
Sensitivity and specificity;
Cost.
The following WHO document provides guidance for national malaria
control programmes to select the appropriate RDT: http://www.wpro.who.in
t/NR/rdonlyres/CF152D7C-25BA-49E7-86D2-DBEE4E5B5974/0/INTERIMNOTESONMALA
RIARDTS_RBM_final2_rev3.pdf
Instructions for use:
Instructions for use are included with the test kit but can also be
provided on request.
Supplier Reference number: 106FRC30 (First ResponseŽ Malaria Ag (pLDH)
Card Test).
to top
|