1. APPROVED MALARIA RDTS

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1 1. APPROVED MALARIA RDTS There are many different Rapid Diagnostic Tests available in the market. To assist partners of the Three Diseases Fund in the selection of the appropriate RDT, the Fund Manager has developed this overview of qualified RDTs based on the publication from WHO describing the performance of different RDTs. Selected RDTs The Fund Manager has selected the following RDTs and partners are restricted to purchase these specific RDTs. In case a partner prefers another type of RDT they are to contact the Fund Manager, discuss the matter and seek approval. Manufacturer Product name species targeted Format Number of Test per Kit Supplied with Indicative price Price per test Access Bio CareStart Malaria HRP2 Test CareStart Malaria pldh/hrp2 Combo Pf Cassette 60 Test, buffer, swab, lancet, capillary Pf, Pan Cassette 60 Test, buffer, swab, lancet, capillary $ $ $ $ J. Mitra, India Premier Medical Corporation, USA Advantage Pf Malaria Card First Response Malaria Ag Card test (HRP2) First Response Malaria Ag Combo Card test (pldh/hrp2) Pf Card 25 Test, buffer, loop, Pf Card 30 Test, buffer, pipette, Pf, Pan Card 30 Test, buffer, pipette, $ $ $ $ Standard Diagnostics Inc, Korea SD Bioline Malaria Ag Pf SD Bioline Malaria Ag Pf/Pan Pf Cassette 25 Test, buffer, loop, Pf, Pan Cassette 25 Test, buffer, loop, $ $ $ $ The following pages provide small descriptions of the different RDTs in the above table. Considerations for choosing a malaria rapid diagnostic test (RDT) product include: 1. The plasmodium species to be detected (P. Falciparum only, or pan-specific and non-falciparum species); 2. Shelf-life and temperature stability in intended conditions of storage and use; 3. Ease of use, including format of the test (e.g. cassette, dipstick, card); 4. Sensitivity and specificity; 5. Cost of the individual tests. The following WHO document provides guidance for national malaria control programmes to select the appropriate RDT: RDTs.pdf (also available from the Fund Manager) Page 1 of 7

2 2. CARESTART MALARIA, COMBO, DEV., RDT, KIT 60 Estimated price: $41.40 General Description: For the rapid qualitative determination of Malaria Histidine-rich Protein 2 (HRP2) and lactate dehydrogenase (pldh) in human blood as aid in the diagnosis of Malaria infection. CareStart (TM) Malaria pldh/hrp2 Antigen Test is designed for the differential diagnosis between Plasmodium falciparum and other Plasmodium species (CareStart Malaria pldh/hrp2 combo test). Technical Specifications: The CareStart (TM) Malaria pldh/hrp2 combo 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 2) is pan specific to lactate dehydrogenase (pldh) of the Plasmodium species (P. falciparum, vivax, malariae, ovale) and the other line (test line 1) consists of a monoclonal antibody specific to Histidine-Rich Protein 2 (HRP2) of the Plasmodium falciparum species. The conjugate pad is dispensed with monoclonal antibodies, which are pan specific to pldh and P. falciparum specific to HRP2. Supplied with: CareStart (TM) Malaria Antigen Test Kit contains following items to perform the assay: 6. Test Device 7. Package Insert 8. Assay Buffer 9. Sample Pipette (Optional) 10. Lancet (Optional) 11. Alcohol Swab (Optional) Precautions: In order to obtain reproducible results, the following rules must be observed: 12. For in vitro diagnostic use only. 13. Use disposable gloves while handling potentially infectious material and performing the assay. Wash hands thoroughly afterwards. 14. Do not use it beyond the expiration date. 15. Do not eat or smoke while handling specimens. 16. Clean up spills thoroughly using an appropriate disinfectant Storage conditions: 4ºC - 30ºC Sensitivity: P. vivax: 96%; P. falciparum: 98% Specificity: 97.5 % Supplier Reference number: G0131 (CareStart Malaria pldh/hrp2 combo test). Page 2 of 7

3 3. CARESTART MALARIA, HRP2, PF, DEV., RDT, KIT 60 General Description: For the rapid qualitative determination of Malaria Histidine-rich Protein 2 (HRP2) in human blood as an aid in the diagnosis of Malaria infection (CareStart Malaria HRP2 test). Technical Specifications: The CareStart (TM) Malaria HRP2 Test contains a membrane strip, which is pre-coated with a monoclonal antibody across a test strip. The monoclonal antibody (test line) is specific to the Histidine-rich Protein 2 of the Plasmodium falciparum species. Conjugate pad is dispensed with monoclonal antibody, which is specific to the Histidine-rich Protein 2 of the Plasmodium falciparum species. Supplied with: CareStart (TM) Malaria Antigen Test Kit contains following items to perform the assay: 17. Test Device 18. Assay Buffer 19. Sample Pipette Precautions: In order to obtain reproducible results, the following rules must be observed: 20. For in vitro diagnostic use only. 21. Use disposable gloves while handling potentially infectious material and performing the assay. Wash hands thoroughly afterwards. 22. Do not use it beyond the expiration date. 23. Do not eat or smoke while handling specimens. 24. Clean up spills thoroughly using an appropriate disinfectant Storage conditions: 4ºC - 30ºC Sensitivity: 98% Specificity: 97.5 % Supplier reference number: G0141 (CareStart Malaria HRP2 test). Page 3 of 7

4 4. FIRSTRESPONSE, PLDH, PAN, PF, CARD, RDT, KIT30 Estimated price: $31.50 General Description: First Response 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 Response Malaria Antigen Test contains a membrane strip, which is precoated 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 Response Malaria Antigen Test Kit contains the following items to perform the assay: Test Devices 2. Assay Buffer 3. Sample Pipette lancets alcohol swabs 6. Package insert 7. Desiccant Precautions: In order to obtain reproducible results, the following rules must be observed: 8. For in vitro diagnostic use only. 9. Use disposable gloves while handling potentially infectious material and performing the assay. Wash hands thoroughly afterwards. 10. Do not use it beyond the expiration date. 11. Do not eat or smoke while handling specimens. 12. Clean up spills thoroughly using an appropriate disinfectant. Storage conditions: 4ºC - 30ºC. Do not freeze. Sensitivity: P. falciparum 95%; P. vivax 92% Specificity: 99.5 % Supplier Reference number: 106FRC30 (First Response Malaria Ag (pldh) Card Test) Page 4 of 7

5 5. SD BIOLINE, AG PF/PAN, CASSETTE, RDT, KIT 25 Estimated price: $21.25 General Description: One step differential diagnosis by detecting HRP-II antigen from Malaria Plasmodium Falciparum and pldh antigen from other species (P. vivax, P. malariae, P. ovale) in human whole blood. Supplied with: One kit contains: - 25 test devices. - Assay diluent - 1 package insert - 25 specimen - collection loops Accessories/Spare parts/consumables (not provided): - Disposable cover tips for pipette - Latex gloves Timer Optional: - Alcohol swab - Lancet Precautions: - Keep away from extreme heat and humidity - Do not freeze test kits or reagent - Full effectiveness of expiry date is under ideal storage condition - Stability of kit components is guaranteed until expiry date - Do not use any components over expiry date Storage conditions: Store between 2-30ºC at room temperature. Sensitivity: Plasmodium falciparum 99.7%; Plasmodium vivax 95.5% Specificity: 99.5% Page 5 of 7

6 6. SD BIOLINE,AGPF,HRP2,CASSETTE,RDT,KIT 25 Estimated price: $17.50 General Description: The SD BIOLINE Malaria Antigen P.f Test is a rapid, qualitative test for the detection of histidine-rich protein II (HRP-II) antigen of Malaria Plasmodium falciparum in human whole blood. It is intended for professional use, only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as microscopic examination of thin blood smear. Technical Specifications: The SD BIOLINE Malaria Antigen P.f test contains a membrane strip, which is pre-coated with mouse monoclonal antibodies specific to the histidine-rich protein II (HRP-II) on test band region. This test device has a letter of T and C as 'Test Line' and 'Control Line' on the surface of the case. Both the Test Line and Control Line in result window are not visible before applying any samples. The Control Line is used for procedural control. Control line should always appear if the test procedure is performed properly and the test reagents of control line are working. Supplied with: The SD BIOLINE Malaria Antigen P.f test kit contains following items to perform the assay. - Test device individually foil pouched with a desiccant - Assay diluent - Disposable sample applicator (5µl) - Instructions for use Accessories/Spare parts/consumables (not provided): Lancet and Alcohol swab Precautions: In order to obtain reproducible results, the following rules must be observed: Perform the test immediately after removing the test device from the foil pouch. Do not use it beyond the expiration date. The shelflife of the kit is as indicated on the outer package. Do not use the test kit if the pouch is damaged or the seal is broken. When transporting or storing the packages, avoid exposure to high temperature (over 45ºC) for a period longer than 1 week. Storage conditions: SD BIOLINE Malaria Antigen P.f Test should be stored at room temperature (1-30ºC). Do not store at refrigerator. The test device is sensitive to humidity as well as to heat. Sensitivity: 99.7 % Specificity: 99.5% Supplier Reference number: 05FK50 (SD Bioline Malaria P.f/P.v) Page 6 of 7

7 7. ADVANTAGE PF MALARIA, CARD, RDT, KIT OF 25 Estimated price: $14.41 General Description: Advantage P.f Malaria CARD is a visual, rapid and sensitive immunoassay for the qualitative diagnosis of P. falciparum specific histidine-rich protein-2 (P.f. HRP-2) in whole blood. Technical Specifications: Advantage P.f Malaria CARD is an immunoassay based on the "sandwich" principle. Colloidal gold is conjugated to anti-p.f. specific HRP-2 antibody. The test uses monoclonal anti-p.f. HRP-2 antibody (test line P.f.) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed. If the sample contains P. falciparum, the colloidal gold conjugate complexes the P.f. specific HRP-2 in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a pink purple band which confirms a reactive test result. Absence of a colored band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control. Supplied with: Advantage P.f Malaria CARD Test kit contains following components to perform the assay: - Malaria Card - Assay Buffer - Sample Loop - Nozzle & Nozzle cap - Instruction Manual Precautions: In order to obtain reproducible results, the following instructions must be followed: - Do not use the kit beyond the expiry date. - Do not combine reagents from different batches as they are optimized for individual batch to give best results. - Do not open the foil pouch until it attains room temperature. - For best results, follow the given test procedure and storage instructions strictly. Storage conditions: - Advantage P.f Malaria CARD should be stored at 4-30ºC in the driest area available till the duration of the shelf life as indicated on the pouch/carton box. - The kit has a shelf life of 24 months from the date of manufacturing. - The kit should not be frozen & must be protected from exposure to humidity. Sensitivity: Plasmodium Falciparum: 100%; Plasmodium Vivax: 100% Specificity: 99.8% Page 7 of 7