High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloida

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High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method Product Name: Syphilis Rapid Diagnostic test Intended Use: The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis. Summary: Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.1 Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985.2 Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users.3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.4 Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.5 The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum or plasma. 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/serum/plasma to the sample well. 4. Hold the buffer 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 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 15-30. If your room temperature is significantly lower than 15, then the interpreting time should be properly increased to 30 minutes. INTERPRETATION OF RESULTS Positive: Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result. Negative: The control line appears in the result window, but the test line is not visible. 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 CHARACTERS: Clinical Sensitivity, Specificity and Accuracy The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPHA Syphilis test using clinical specimens. The results show that the relative sensitivity of The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is 99.5% and the relative specificity is 99.3%. Syphilis Rapid Test Device vs. TPHA - - - - Method | TPHA | Total Results | Syphilis Rapid Test Device | Results | Positive | Negative | Positive | 394 | 4 | 398 | Negative | 2 | 540 | 542 | Total Results | 396 | 544 | 940 | - - - - Relative sensitivity: 99.5% (98.2%-99.9%)* Relative specificity: 99.3% (98.1%-99.8%)* Accuracy: 99.4% (98.6%-99.8%)* * 95% Confidence Intervals NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

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Oriental New Life Medical Device Technology Co.,Ltd.

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