Genesprint | STDs 5in1 Rapid Test Kits
Genesprint STDs 5in1 Rapid Test Kits is a single-use rapid test cassette composed of 5 STDs antibody/antigen rapid tests, each of which detects a specific antibody/antigen (including: Chlamydia antigen, Trichomonas Vaginalis antigen, Neisseria Gonorrhoeae antigen, HIV (Type 1+2) antibody and Treponema Pallidum (TP) antibody) directly from body fluid(vaginal Iubrication), saliva and urine specimens. This device is used for in vitro diagnostic of Chlamydia, Trichomonas, Gonorrhea, HIV Type 1+2 and Syphilis infections.
The test results indicate the existing of Chlamydia trachomatis antigen, Trichomonas vaginalis antigen, Neisseria gonorrhoeae antigen, Human Immunodeficiency Virus (HIV) type 1/2 antibody and Treponema pallidum (TP) antibody in 5 independent indicator windows.
Positive: Two lines appear. One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test region (T). This positive result indicates the presence of those STD antigen/antibody.
Negative: One colored line appears in the control region (C). No line appears in the test region (T). This negative result indicates the absence of those STD antigen/antibody.
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 using a new test panel. If the problem persists, discontinue using the lot immediately and contact your local distributor.
NOTE: The intensity of the red color in the test line region (T) will vary depending on the concentration of antigen/antibody present in the specimen. Therefore, any shade of red in the test region (T) should be considered positive.
The Chlamydia Antigen Rapid Test Accuracy:
A side-by-side comparison was conducted using the GenesPrint Chlamydia Antigen Rapid Test and the laboratory chlamydia antigen test. 1020 clinical specimens from three Professional point of care sites were evaluated. The agreement between the GenesPrint Chlamydia Antigen Rapid Test and the laboratory chlamydia antigen tests is 98.19% for positive specimens, and 99.37% for negative specimens, total compliance rate: 99.12%. This study demonstrated that the Chlamydia Antigen Rapid Test is substantially equivalent to the laboratory device.
The Trichomonas Vaginalis Antigen Rapid Test Accuracy:
Sensitivity and Specificity: Trichomonas vaginalis antigen rapid test has tested with positive and negative clinical samples tested by laboratory, 1050 clinical specimens were evaluated. In a comparison of GenesPrint Trichomonas vaginalis antigen rapid test cassette with laboratory testings, GenesPrint Trichomonas vaginalis antigen rapid test cassette had a sensitivity of 97.75%, a specificity of 98.71%, and a total agreement of 98.38%.
The Neisseria Gonorrhoeae Antigen Rapid Test Accuracy:
Cut off level (Sensitivity): 1 x 105CFU/ ml. In a comparison of GenesPrint Neisseria Gonorrhoeae antigen rapid test cassette with laboratory testings, 1050 clinical specimens were evaluated. GenesPrint Neisseria Gonorrhoeae antigen rapid test cassette had a sensitivity of 98.01%, a specificity of 98.57%, and a total agreement of 98.38%.
The HIV (Type 1+2) Antibody Rapid Test Accuracy:
The HIV (Type 1+2) Antigen Rapid Test Cassette have been tested with the same blood samples from patients. HIV Type 1+2 rapid test cassette has tested with positive and negative clinical samples tested by laboratory, 1020 clinical specimens were evaluated. In a comparison of our HIV 1+2 test device(urine) with the same blood samples from patients, the result gave a sensitivity of 99.81%, a specificity of 97.00%, and a total agreement of 98.43%.
The Treponema Pallidum Antibody Rapid Test Accuracy:
GenesPrint Syphilis Test has been compared with a laboratory syphilis test, 678 clinical specimens were evaluated, demonstrating an overall accuracy greater or equal to 98%. GenesPrint Syphilis Test uses an antigen that is highly specific for detecting TP antibodies in whole blood / serum / plasma. The results show that the relative Sensitivity of GenesPrint Syphilis Test is 98.6%, Relative Specificity 99.1%, and accuracy 99%.