Malaria Detection Kit/ Rapid Malaria Test Cassette - X25

https://supply.unicef.org/s0003775.html
ENGLISH INTERPRETATION OF RESULTS (Please refer to the illustration above) 
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). *NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of antigen, vis., HRP-II present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. 
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
 QUALITY CONTROL Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal valid procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. 
LIMITATION 1. The Malaria P.f. Rapid Test Cassette (Whole Blood) is for in vitro diagnostic use only. This test should be used for the detection of P.f. antigen in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f. antigen concentration can be determined by this qualitative test. 2. The Malaria P.f. Rapid Test Cassette (Whole Blood) will only indicate the presence of P.f. antigen the specimen and should not be used as the sole criteria for the diagnosis of malaria infection.3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of malaria infection. EXPECTED VALUES The Malaria P.f. Rapid Test Cassette (Whole Blood) has been compared with traditional thick or thin blood smears microscopic analysis. The correlation between the two systems is over 99.0%.