Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
INTENDED USE
PRINCIPLE
WARNINGS AND PRECAUTIONS
SPECIMEN COLLECTION
TEST PROCEDURE
INTERPRETATION OF RESULTS
PERFORMANCE CHARACTERISTICS
LIMITATIONS
BIBLIOGRAPHY
CATALOG
Catalog No. Product Name Note
ABT-IDT-A85 Malaria P.f. Whole Blood Strip CE
ABT-IDT-B85 Malaria P.f. Whole Blood Cassette CE
INTENDED USE
Accu-Tell ® Rapid Malaria(p.f.) Test is A Colloidal Gold Enhanced, Rapid Immunochromatographic Assay for testing, in vitro , the presence of Plasmodium falciparum malaria in blood. The test is an antigen-capture assay detecting presence of a specific soluble protein, histidine-rich protein II (PfHRP-II), which is present in, and released from, infected red blood cells. The assay is intended for use with whole blood and does not require additional instruments.
PRINCIPLE
A capture monoclonal antibody is immobilized on the nitrocellulose strip. The red blood cells are lysed releasing HRP-II which binds Selectively to this antibody as the blood is wicked up the strip. 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 procedural control line) demonstrates the test has been performed correctly.
WARNINGS AND PRECAUTIONS
1. All positive results must be confirmed by an alternative method.
2. Treat all specimens as though potentially infectious.
3. Wear gloves and protective clothing when handling specimens.
4. Standard safety precautions in the handling of bioharzardous material.
5. Should be observed in specimen handling. Dispose of used lancets.
6. Capillary tubes and cassettes in designated biohazard disposal containers.
7. Devices used for testing should be autoclaved before disposal.
8. Do not use kit materials beyond their expiration dates.
9. Do not interchange reagents from different lot of kit.
SPECIMEN COLLECTION
1. Collect whole blood specimens following regular clinical laboratory procedures.
2. Storage: A specimen should be refrigerated if not used the same day of collection. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.
TEST PROCEDURE
1. Dispense 1 drop (10μl) of whole blood to the “S” well of the test cassette using the plastic dropper provided according to the figure.
2. Add three drops of Sample Diluent to the “D” well after the specimen is added.
3. Interpret test results at 15 minutes.
Notes:
1. Applying sufficient amount of sample diluent is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of diluent to sample well.
2. The positive results could appear as soon as 1 minute for a sample with high levels of Malaria.
3. Do not interpret result after 30 minutes.
INTERPRETATION OF RESULTS
Positive: Both black test band and black control band appear on the membrane. The lower the HRP-II concentration, the weaker the test band.
Negative: Only the black control band appears on the membrane. The absence of a test band indicates a negative result.
Invalid: There should always be a black control band in the control region regardless of test result. If control band is not seen, the test is considered invalid. Repeat the test using a new test device.
Note: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible.
PERFORMANCE CHARACTERISTICS
The following data was generated by from previously frozen whole blood samples, and was determined by correlation to standard thick and thin smear microscopic examination with discrepants evaluated via PCR. Retrospective study results are summarized below:
The Malaria Test did not cross-react with any of the following species of malaria: P.malariae, P.ovale, and P.vivax
LIMITATIONS
1. The assay should be performed in normal room temperature.
2. Test cards should be used immediately after being taken from the package. Avoid exposing the test strips in the air for too long before use.
3. The test cards may be stored under room temperature and dry condition. If refrigerated, the strips should be brought to room temperature before testing.
4. Although the test is very accurate, a low incidence of false results may occur.
5. If questionable results are obtained, the test should be repeated on a fresh whole blood specimen using a new device.
BIBLIOGRAPHY
1. WHO. World malaria situation in 1994 .Part I. Population at risk[J].Wkly Epidemiol Rec, 1997, 72(36):269-74
2. Quintana M, Piper R, Boling HL, et al. Malaria diagnosis by dipstick assay in Honduran population with coendemic Plasmodium falciparum and Plasmodium vivax[J]. Am J Trop Med Hyg, 1998, 59(6): 868-871
3. Tjitra E, Suprianto S, Dyer M, et al. Field evaluation of the ICT malaria P.f/P.v immunochromatographic test for detection of Plasmodium falciparum and Plasmodium vivax in patients with malaria in eastern Indonesia [ J ].Clin a presumptive clinical diagnosis of Microbiol. 1999, 37 ( 8 ):2412—2417.
4. Palmer CJ, Validum L, Lindo J, et al.rapid malaria TrancR Sne diagnostic test during anti Mrd Hve.1999.93(5) Field evaluation of the OptiMAl —alaria therapy in Guyana}J}:517—518.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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