High Accuracy Infectious Disease Blood Tests Quick Operation Gold Colloidal

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High Accuracy Malaria pf/pv Rapid Diagnostic test, easily and quick operation, Gold Colloidal method Product Name: Malaria P.f & P.v Antigen Test (Cassette) NTENDED USE: Malaria P.f & P.v Ab test is an immunochromatographic (rapid) test for the qualitative detection of antigen of all specific to Plasmodium falciparum and Plasmodium vivax simultaneously in human serum or plasma or whole blood. TEST PRINCIPLE The Malaria P.f./P.v. Rapid Test Device (Whole Blood) 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 strip. 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.vivaLDH or both, a colored line will appear in P.f line region or P.v. line region or two colored lines will appear in P.f line region and P.v. line region. The absence of the colored 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.vivaLDH. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. TEST PROCEDURE 1. Bring the pouched test device to room temperature(15-30) prior to testing. Do not open pouch until ready to perform the assay. 2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface. 3. Use the pipette to draw and slowly add 1 drop of whole blood to the sample well. 4. Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well. 5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes. Caution: The above interpreting time is based on room temperature range of 15 - 30C. If your room temperature is significantly lower than15 C, then the interpreting time should be properly increased to 30 minutes. INTERPRETATION OF RESULTS Malaria P.f Positive The control line and Malaria P.f line (T1) are visible in the result window. The test is positive for Malaria P.f. Malaria P.v Positive The control line and Malaria P.v line (T2) are visible in the result window. The test is positive for Malaria P.v. Malaria P.f and Malaria P.v Positive The control line, Malaria P.f (T1) and Malaria P.v (T2) lines are visible in the result window. The test is positive for Malaria P.f and Malaria P.v. Negative The control line is the only line visible in the result window. No Malaria P.f or Malaria P.v has been detected. Invalid If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region. Performance Study Sensitivity The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) has been tested with microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is >98% when compared to results obtained with microscopy. Specificity The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and P.vivaxLDH antigens in whole blood. The results show that the specificity of the Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is over 99.9%, when compared to results obtained with microscopy. - - - - Method | | Microscopy | Total | Malaria P.f./ P.v. | | Results | Positive | Negative | Results | Rapid Test | | | P. v. | P. f. | | | | | Positive | 49 | 80 | | 0 | 129 | Device | | | | Negative | 1 | 0 | | 451 | 452 | | | | Total | Results | 50 | 80 | | 451 | 581 | | | | | | | | | | | | | | | | | - - - - Comment: Blood Samples infected by Plasmodium falciparum (n=80).Plasmodium vivax (n=50) were included, as well as 451 malaria negative samples to be confirmed with microscopy. Relative Sensitivity for P.f.-specific antigens: 80/80> 99.9% (96.4%100.0%)* Relative Sensitivity for P.v. antigens: 49/50=98.0% (89.6%100.0%)* Relative Specificity: 451/451>99.9% (99.3%100.0%)* Accuracy: (49+80+451)/(50+80+451)=580/581=99.8% (99.0%100.0%)* * 95% Confidence Interval - - - - Minimum Detection Level | | | | | Type | | | Parasites/l | P. falciparum | | 200 | P.vivax | | 1500 | - - - -

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Oriental New Life Medical Device Technology Co.,Ltd.

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