EZ-M Malaria Rapid Screen Test Kit

Intended Use

The One Step 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, Plasmodium lactate dehydrogenase (LDHp), 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 of The Procedure

A capture monocional antibody is immobilized on the nitrocellulose strip. The red blood cells are lysed releasing LDHp which binds Selectively to this antibody as the blood is wicked up the strip. The signal reagent is coated with specific antibodies which blind 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.

Before Testing

  1. Bring the device, sample diluent, and specimens to room temperature.
  2. Remove the card fro m the sealed pouch.

    Select the finger for puncture, usually the side of the third or fourth finger. Clean with antiseptic and allow air dry.

    Puncture the finger with a sterile lancet.

    Blood will well to the surface. Redo Procedure on another finger if necessary, Collect the blood using the plastic dropper provided.

Assay Procedure

  1. Dispense 1 drop (10μ) of whole blood to the "S" well of the test card 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.

Reagents and Materials Supplied

  • Test cards / test strips individually foil pouched with a desiccant
  • Plastic dropper
  • Sample Diluent
  • Package Insert

Sample Collection and Storage

  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.

Testing

  1. Bring the device, sample diluent, and specimens to room temperature.
  2. Remove test card from the sealed pouch.
  3. Select the finger for puncture, usually the side of the third or fourth finger. Clean with antiseptic and allow to air dry.
  4. Puncture the finger with a sterile Lancet.
  5. Blood will well to the surface. Redo procedure on another finger if necessary. Collect the blood using the plastic dropper provided.

Reading the Test Results

  1. Positive: Both black test band and black control band appear on the membrane. The lower the LDH concentration, the weaker the test band.
  2. Negative: Only the black control band appears on the membrane. The absence of a test band indicates a negative result.
  3. Invalid: There should always be a black control band in the control region regardless of test results. 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.