General Description:
For the rapid qualitative determination of Malaria lactate dehydrogenase
(pLDH) in human blood as an aid in the diagnosis of Malaria infection
(CareStart® Malaria pLDH pan test)
Technical Specifications:
The CareStart (TM) Malaria Antigen Test contains a membrane strip, which
is pre-coated with a monoclonal antibody as single lines across a test
strip. The monoclonal antibody is specific to the lactate dehydrogenase
of Plasmodium species (P. falciparum, vivax, malariae, ovale). The
conjugate pad is dispensed with the monoclonal antibody, which is pan
specific to the lactate dehydrogenase of Plasmodium species
Supplied with:
CareStart (TM) Malaria Antigen Test Kit contains following items to
perform the assay:
Test Device
Package Insert
Assay Buffer
Sample Pipette (Optional)
Lancet (Optional)
Alcohol Swab (Optional)
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:
4ºC - 30ºC
Performance characteristics:
Sensitivity: P. vivax 96%; P. falciparum 97%
Specificity: 98.5 %
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: G0111 (CareStart® Malaria pLDH pan test).
to top
|