CTK Biotech, USA  Malaria Pf/Pan Ag Rapid

30 Test

The TRUSTline Malaria Pf/Pan Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax (Pv), P. ovale (Po), or P. malariae (Pm) antigen in human blood specimen.

• Meets WHO acceptance criteria
• Ease of use, requires minimal training of personnel
• Expanded testing facility options including areas where quality microscopy is not available
• Quick turnaround time to results
• Increased cost effectiveness, no high cost equipment monitoring
• Availability of Positivia external controls
• Pf detection: Sensitivity - 100%, Specificity – 100
• Pan detection: Sensitivity - 95%, Specificity - 100%
• 24 month shelf life at 1-30 °C

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• 5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)
• Blood Lysis buffer (10 mL/bottle)
• One package insert (instruction for use)

TEST PRINCIPLE : The TRUSTline Malaria Pf/Pan Ag Rapid Test is a lateral flow chromatographic immunoassay. The strip in the test cassette consists of: 1) a burgundy colored conjugate pad containing monoclonal anti-pHRP-II antibody conjugated with colloidal gold (pHRP-II-gold conjugates), monoclonal antipLDH antibody conjugated with colloidal gold (pLDH-gold conjugates) and a control antibody conjugated with colloidal gold and 2) a nitrocellulose membrane strip containing two test lines (Pan and Pf lines) and a control line (C line). The Pan line is pre-coated with anti-pLDH antibody for the detection of infection with any of the four species of plasmodium, the Pf line is pre-coated with antipHRP-II antibodies for the detection of Pf infection, and the C line is coated with a control line antibody. During the assay, an adequate volume of the blood specimen is dispensed into the sample well (S) of the test cassette, and a lysis buffer is added to the buffer well (B). The buffer contains a detergent that lyses the red blood cells and releases various plasmodium antigens which migrate by capillary action across the strip held in the cassette.  The pHRP-II, if present in the specimen, will bind to the pHRP II-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-pHRP-II antibodies forming a burgundy colored Pf line, indicating a Pf positive test result.  The pLDH, if present in the specimen, will bind to the pLDH-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-pLDH antibody forming a burgundy colored Pan line. In the presence of a Pf line, a Pan line indicates a positive result for Pf or a positive result for Pf and any of the other three Plasmodium species (Pv, Pm, Po). In the absence of a Pf line, a Pan line indicates a positive result for Pv, Po or Pm or a combination of any of these three Plasmodium species