Rapid And Efficient Malaria Pf Pv Ag Rapid Test Disposable Cassette Formats

Rapid And Efficient Detection Of Malaria P.f/P.v

      The Malaria P.f./P.v. Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of two kinds of circulating Plasmodium falciparum (P.f.) and Plasmodium vivax (P.v.)in whole blood.

Detection Principle

      The Malaria P.f./P.v. Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f and P.v antigens in whole blood. The membrane is pre‐coated with anti‐HRP‐II antibodies and anti‐pLDH antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre‐coated on the test strip. The mixture then migrates upward on the membrane by capillary action, reacts with anti‐Histidine‐Rich Protein II (HRP‐II) antibodies on the membrane on P.f Test Line region and with anti‐pLDH antibodies on the membrane on P.v. Line region. If the specimen contains HRP‐II or Plasmodium‐specific P.vivaLDH or both, a colored line will appear in P.f line region or P.v. line region or two colored lines will appear in P.f line region and P.v. line region. The absence of the colored lines in P.f line region or P.v. line region indicates that the specimen does not contain HRP‐II and/or Plasmodium‐specific P.vivaLDH. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND STORAGE

The kit can be stored at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

DIRECTIONS FOR USE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15‐30°C) prior to testing.

1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour. 
2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a dropper:

• To use a Pipette: Transfer 5ul  of whole blood to specimen well of the test device, and then add 3 drops of buffer (approximately 180ul) to the buffer well, and start the timer. 
• To use a Disposable Specimen Dropper: Hold the dropper vertically; draw the specimen up to the Fill Line (approximately 5ul). Transfer the specimen to the specimen well, then add 3 drops of buffer (approximately 180ul) to the buffer well and start the timer. 
• Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

NOTE:

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The color intensity of P.f or P.v. test lines may vary depending on the concentration of antigens, viz., HRP‐II or P.vivaxLDH present in the specimen.

LIMITATIONS OF THE TEST

• . The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is for in vitro diagnostic use only. This test should be used for the detection of P.f and P.v antigens in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f. and P.v concentration can be determined by this qualitative test. 
• The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) will only indicate the presence of antigens of Plasmodium sp. (P.f and P.v) in the specimen and should not be used as the sole criterion for the diagnosis of malaria infection. 
• As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. 
• If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of

Preservation and stability of products

      The kit can be stored at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

KIT COMPONENTS

• Test devices
• Disposable specimen droppers 
• Buffer 
• Package insert

MATERIALS REQUIRED BUT NOT PROVIDED

• Pipette and disposable tips (optional) 
• Specimen collection containers 
• Lancets (for fingerstick whole blood only) 
• Time