(HRP II) For the quantitative detection of Plasmodium falciparum (P.f.) antigens in whole blood. In-vitro diagnostic test in immunogromatographic strip format ML01 (25 Tests) |
| [TEST PRINCIPLE] [INTENDED USE] For diagnostic use with human whole blood. |
| [INTENDED USER] The test is intended to be performed by a trained user. The ICT Malaria P.f. cassette is a rapid, in vitro diagnostic test for the detection of circulating Plasmodium falciparum antigens. The test uses one antibody specific to histidine-rich protein II antigen of P.f. HRPII that has been immobilized across the test strip. A procedural control line is also immobilized across the test strip and will always appear if the test has been performed correctly. 5µl of whole blood is applied to the sample well. Running buffer is then added to the large base well which lyses the whole blood and allows migrations across the membrane. The conjugate pad contains colloidal gold conjugated antibodies that are directed against HPRII. When a positive sample is applied P.f. antigens bind to the gold conjugated antibodies. The antibody/antigen complex continues migration along the test strip where they are captured by immobilized antibodies. When capture occurs a pink-purple control line will form in the window. When a negative sample is applied only the control line will appear. |
| [SPECIMEN COLLECTION] Use the sampling device provided to collect 5µl of capillary blood, or venous blood collected into EDTA tubes. |
| * | To obtain capillary blood via puncture of a finger, heel or other appropriate site, cleanse the area with a sterile swab and dry with a sterile pad. Use a lancet to puncture the skin and collect the blood directly into the pipette . Use the blood immediately. |
| * | Collect venous blood, by the standard venipuncture procedure, into an EDTA tube. If the test cannot be performed immediately, the blood may be stored for up to three days at 2°C - 8°C. |
| [PRECAUTIONS AND WARNINGS] | |
| • | Optimal results will be obtained by strict adherence to this protocol. Reagents must be added carefully to maintain precision and accuracy. Treat used cassettes as biohazardous. Do not reuse cassettes. |
| • | Biological contamination of dispensing equipment, containers or reagents can lead to false results. Observe established precautions against micorbiological and serological hazards in specimen handling, disposal and throughout all procedures. |
| • | Store kits at 4°C - 40°C. DO NOT FREEZE. |
| • | Running buffer contains sodium azide as a preservative. Sodium azide is toxic and should, therefore, be handled carefully, avoiding ingestion or skin contact. It may react with lead or copper plumbing to form explosive metal azides. Flush with a liberal volume of water when disposing of unwanted reagent. |
| • | Do not mix reagents from different kit lots, or use kits beyond expiry date. |
| • | Do not use if damaged. |
| • | Do not use if devices colour has reached saturation. |
| [LIMITATIONS OF PROCEDURE] | |
| • | The test is able to identify an infection caused by Plasmodium falciparum (P.f.) |
| • | Diagnosis should be made using results of this test together with other clinical and laboratory findings. |
| • | A negative test result does not exclude infection with malaria, particulary at low levels of parasitemia. When indicated, perform the reference method (microscopical examination of thick and thin blood films). |
| • | Certain HRPII mutations may not be picked-up (false negative result). |
| • | This test has not been evaluated for monitoring treatment of malaria. Malaria antigens can still be detected for serveral days after elimination of the parasite by antimalarial treatment. This is especially the case for HRPII. |
| • | Patients with rheumatoid factors, with chronic viral infections (such as hepatitis B or C) or parasitic infections (such as schistosomiasis and trypanosomiasis) may have false positive results. |
| • | Lipaemic and icteric samples can impair the results. |
| • | The internal control (control line) only validates the migration
of the test. It does not guarantee that the correct sample was used, that the sample was applied correctly or that the sample was correctly
stored. |
| [SENSITIVITY AND SPECIFICITY] | |
| Numerous evaluations carried out by independent laboratories showed a 100% sensitivity and specificity when tested against their 200 parasites/ml standard. | |
| [KIT CONTENTS] | |
| Materials provided • Individually packaged cassettes • 5µl collection device (for blood collection) • Buffer • Package insert • Lancets • Sterile swab (for blood collection) |
|
| Materials required but not provided | |
| • Timer • Biohazard Container • Gloves |
| [TEST PROCEDURE] |
|
| Prior to use, open the foil bag to be used, exposing the cassette. Select the finger for puncture, usually the side of the third or fourth finger. Clean with antiseptic and allow to air dry. Puncture the finger with a sterile lancet. Blood will well to the surface. Redo procedure on another finger is necessary. |
 |
||||
| 1. | Touch the sampling device supplied to the blood drop and allow the
blood to fill up the cup. |
3. | Place 5 drops of the reaction buffer into the large base well. |
|
| 2. | Transfer blood to the test cassette by gently touching the filled
cup into the small sample well. |
4. 5. |
Allow the reaction to proceed for 15 minutes. Read the result and dispose of the cassette. | |
| [SYMBOL KEY] Only the internationally recognized symbols in use:  |
|
| [RESULTS INTERPRETATION] |
|
 |
|
| Control Line: A control line will form in the window
if the test was performed correctly. Negative: For a negative sample, a pink - purple Control Line (C) will form. No other line will appear Positive: For a positive sample, a pink - purple Control Line (C) and a pink - purple coloured Sample Line (T) will appear below the Control Line (C). Invalid: If no lines are visible, or if no Control Line (C) forms, whether or not a Sample Line (T) appears, the assay is invalid and should be repeated with a new sample and cassette. |
| [ORDERING INFORMATION] Ref: ML01 25 TEST KIT |
|
| [CONTACT INFORMATION] ICT INTERNATIONAL 271 De Goede Hoop Estate Noordhoek, Cape Town South Africa PO Box 912 Noordhoek 7985 Cape Town, South Africa Technical Support Tel: + 27 82 441 1922 Email :russell@ictdiagnostics.co.za www.ictdiagnostics.co.za Manufactured under: EN ISO 13485 Effective date: 2020-04-13 |
| [REFERENCES] |
|
| 1. | M H Craig, B L Bredenkamp, C H Vaughn Williams, E J Rossouw, V J Kelly, I
Kleinschmidt, A Martineau and G F J Harry. Field and Laboratory comparative evaluation of ten rapid malaria diagnostic tests. Transactions of the Royal Society of Tropical Medicine and Hygiene (2002) 96, 1-8. |
| 2. | Gillet P, Scheirlinck A, Stokx J, De Weggeleire A, Chauque H, Canhanga O,
Tadeu B, Mosse C, Tiago A, Mabunda S, Bruggeman C, Bottieau E, Jacobs J: Prozone in malaria rapid diagnostics tests: how many cases are missed?
Malar J 2011, 10:166. http://www.malariajournal.com/content/10/1/166 |
| 3. | Gillet P, Mori M, Van Den Ende J, Jacobs J: Buffer substitution in
malaria rapid diagnostic tests causes false-positive results. Malar J 2010, 9:215 http://www.malariajournal.com/content/9/1/215 |
| 4. | Maltha J, Gillet P, Jacobs J. REVIEW: Malaria rapid diagnostic
tests in endemic settings. Clin Microbial Infect 2013; 19: 399-407. http://onlinelibrary.wiley.com/doi/10.1111/1469-0691.12151/pdf |
| Rev. Oct 2016.10.05 Code: IPI-ML01E |
|