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. mal card, malaria ag,Malaria,Maleria Antigens,Elisa malaria,Jmitra malaria,Malaria,Maleria antibody card,Mall card,Maleria cards,Maleria strips,Maleriya kits,Malaria card,Maleriya card,Malaria antigen,malaria malarya ,offer