Test ID: MALAG
CPT code:
LOINC: 76772-3
Specimen Type: EDTA – venous 1 ml min or full EDTA capillary tube from kit
Frequency: Setup: Daily; TAT 24 hrs; pos results called
Instructions: Performed at VCSF. Lavender top tube or fingerstick into EDTA capillary tube provided in test kit
Text: Detects P. falciparum unique antigen and/or pan-malarial antigen
1. A negative test does not exclude infection with malaria, particularly at low levels of parasitemia. Results should be used in conjunction withother lab and clinical findings to make an accurate diagnosis. Another sample can be collected and retested.
2.The test detects antigen from both viable and non-viable malaria organisms, including gametocytes and sequestered P. falciparum parasites.Test performance depends on antigen load in the specimen and may not directly correlate with microscopy.
3. Performance has not been established for monitoring treatment of malaria. Residual antigen may persist after elimination of the parasite by anti-malarial treatment.
4. Samples with positive rheumatoid factor (Rf) titers may produce false positive results.
5. Analytical reactivity testing demonstrates that the pan malaria test line (T2) on the test is capable of detecting all four malaria species (falciparum, vivax, ovale, or malariae). During clinical trials, insufficient data was tenerated to support clinical performance claims for the detection of P. malariae or P. ovale. Clinical performance claims for this test are made for P. falciparum and P. ovale detection only.
6. The test is not intended for use in screening asymptomatic populations.
Methodology: Immunochromatographic membrane assay.