Malaria Rapid Tests CE Marking


Biopanda Reagents offers tests for various species of Plasmodium parasite antigens present in human whole blood samples.

Malaria P.f. Rapid Test

Product Number (Cassette): RAPG-MLR-001
Product Number (Strip): RAPG-MLR-002

Pack size

50 tests (Strip)
10 or 20 tests (Cassette) lancets and sterile wipes are available at customer's request

Product Description

The Biopanda Malaria P.f. Rapid Test qualitatively detects Plasmodium falciparum (P.f.) antigen in human whole blood samples. This test applies lateral flow immuno-chromatography and is a tool to assist in the diagnosis of malaria.

Test Attributes

  • Whole blood may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose malarial infections
  • Results increase the effective administration of anti-malarial drugs

Test Procedure (strip)

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the blood specimen is mixed well.
  2. Open the foil wrapped pouch and remove the test strip. Use the test as soon as possible or within one hour of opening.
  3. Transfer the whole blood specimen to the blood collection tube using a pipette or dropper.
    1. Pipette use: Transfer 10 µl of whole blood to the collection tube, then add 3 drops of buffer (180 µl) and start the timer.
    2. Dropper use: Hold the dropper provided vertically and draw the blood specimen (10 µl) to the fill line (see illustration). Transfer the specimen to the collection tube, then add 3 drops of buffer (180 µl) and start the timer.
  4. With arrows facing towards the blood specimen, immerse the strip into the sample and start the timer. Ensure the blood specimen does not pass the maximum line on the test strip.
  5. Read the results at 10 minutes. Results read after 20 minutes are considered invalid.
Malaria pf Rapid Test Malaria pf Rapid Test Malaria pf Rapid Test

Principle

The Malaria P.f. Rapid Test Strip is a qualitative, membrane based immunoassay for the detection of P.f. antigen in whole blood. The membrane is precoated with P.f. antibody. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with P.f. antibody on the membrane on the test line. If the specimen contains P.f. antigen, a coloured line will appear in the test region. The absence of the coloured line in the test region indicates that the specimen does not contain P.f. antigen. To serve as a procedural control, a coloured line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative sensitivity: 99.9%
  • Relative specificity: 99.9%
  • Accuracy: 99.9%

Storage Conditions

+2 - 30 °C

Malaria P.f./P.v. Rapid Test

Product Number (Cassette): RAPG-MLR-004

Pack size

10 or 20 tests

Product Description

The Biopanda One Step Rapid Test detects and differentiates between Plasmodium falciparum (pf) and Plasmodium vivax (pv) in human blood samples. This test applies lateral flow immuno-chromatography and is a tool to assist in the diagnosis of malaria.

Test Attributes

  • Whole blood may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose malarial infections
  • Results increase the effective administration of anti-malarial drugs

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the blood specimen is mixed well.
  2. Open the foil wrapped pouch and remove the cassette. Use the test as soon as possible or within one hour of opening.
  3. Transfer the whole blood specimen to the blood collection tube using a pipette or dropper.
    1. Pipette use: Transfer 5 µl of whole blood to the specimen well of the cassette, then add 3 drops of buffer (180 µl) and start the timer.
    2. Dropper use: Hold the dropper provided vertically and draw the blood specimen (5 µl) to the fill line (see illustration). Transfer the specimen to the specimen well on the cassette, then add 3 drops of buffer (180 µl) and start the timer.
  4. Read the results at 10 minutes once the coloured line(s) have appeared. Results read after 20 minutes are considered invalid.
Malaria pf/pan Rapid Test Malaria pf/pan Rapid Test

Principle

The Biopanda Malaria P.f. /P.v. Rapid Test Cassette 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 cassette. 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. vivaxLDH or both, a coloured line will appear in P.f. line region or P.v. line region or two coloured lines will appear in P.f. line region and P.v. line region. The absence of the coloured 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. vivaxLDH. To serve as a procedure control, a coloured line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative sensitivity p.f. antigens: 99.9%
  • Relative sensitivity p.v. antigens: 98.2%
  • Relative specificity: 99.9%
  • Accuracy: 99.8%

Storage Conditions

+2 - 30 °C

Malaria P.f./Pan Rapid Test

Product Number (Cassette): RAPG-MLR-003

Pack size

10 or 20 tests

Product Description

The Biopanda Malaria P.f./Pan Rapid Test qualitatively detects four antigens in human whole blood samples: Plasmodium falciparum (P.f.), Plasmodium vivax, (P.v.) Plasmodium ovale (P.o.), Plasmodium malariae (P.m.). This test applies lateral flow immuno-chromatography and is a tool to assist in the diagnosis of malaria.

Test Attributes

  • Whole blood may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose malarial infections
  • Results increase the effective administration of anti-malarial drugs

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the blood specimen is mixed well.
  2. Open the foil wrapped pouch and remove the cassette. Use the test as soon as possible or within one hour of opening.
  3. Transfer the whole blood specimen to the blood collection tube using a pipette or dropper.
    1. Pipette use: Transfer 5 µl of whole blood to the specimen well of the cassette, then add 3 drops of buffer (180 µl) and start the timer.
    2. Dropper use: Hold the dropper provided vertically and draw the blood specimen (5 µl) to the fill line (see illustration). Transfer the specimen to the specimen well on the cassette, then add 3 drops of buffer (180 µl) and start the timer.
  4. Read the results at 10 minutes once the coloured line(s) have appeared. Results read after 20 minutes are considered invalid.
Malaria pf/pan Rapid Test Malaria pf/pan Rapid Test

Principle

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

Performance Characteristics

  • Relative sensitivity p.f. antigens: 99.9%
  • Relative sensitivity p.v. antigens: 98.2%
  • Relative specificity: 99.9%
  • Accuracy: 99.8%

Storage Conditions

+2 - 30 °C

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