CTK Biotech, USA Malaria Pf/Pv Ag Rapid

30 Test

The TRUSTline Malaria Pf/Pv Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) and vivax (Pv) 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 Ag: Sensitivity - 95.45%, Specificity - 97%
• Pv Ag: Sensitivity - 95%, Specificity - 98%
• 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 (1 bottle, 10 mL)
• One package insert (instruction for use)

TEST PRINCIPLE : The TRUSTline Malaria Pf/Pv Ag Rapid Test is a lateral flow chromatographic immunoassay. The strip test components consist of: 1) a burgundy colored conjugate pad containing mouse anti-PvLDH antibody conjugated with colloidal gold (Pv-LDH-gold conjugates) and mouse anti-pHRP-II antibody conjugated with colloidal gold (pHRP-II-gold conjugates), 2) a nitrocellulose membrane strip containing two test bands (Pv and Pf bands) and a control band (C band). The Pv band is precoated with another mouse anti-Pv-LDH specific antibody for the detection of Pv infection, the Pf band is pre-coated with polyclonal anti-pHRP-II antibodies for the detection of Pf infection, and the C band is coated with goat anti-mouse IgG. 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 antigens, which migrate by capillary action across the strip held in the cassette. Pv-LDH if present in the specimen will bind to the Pv-LDH-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-Pv-LDH antibody, forming a burgundy colored Pv band, indicating a Pv positive test result. Alternatively, 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 band, indicating a Pf positive test result. Absence of any test bands suggests a negative result. The test contains an internal control (C band) which should exhibit a  burgundy colored band of the immunocomplex of goat anti-mouse IgG / mouse IgG (anti-Pv-LDH and anti-pHRP-II)-gold conjugates regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device