OnSite Syphilis Ab Combo_R0031C_English.pdf - MD Doctors Direct

OnSite Syphilis Ab Combo Rapid Test-(Serum / Plasma / Whole Blood) Page 2 of 2Step 5:Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.Result1 drop of specimen 1 drop of sample diluent 15 minutesSet up timer.Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1minute.Don’t read result after 15 minutes. To avoid confusion, discard the test device afterinterpreting the result.QUALITY CONTROLUsing individual OnSite Syphilis Ab Combo Rapid Test cassettes as described in the AssayProcedure above, run 1 Positive Control and 1 Negative Control (provided upon request) underthe following circumstances to monitor test performance:1. A new operator uses the kit, prior to performing testing of specimens.2. A new test kit is used.3. A new shipment of kits is used.4. The temperature used during storage of the kit fall outside of 2°C-30°C.5. The temperature of the test area falls outside of 15°C-30°C.RESULT1. NEGATIVE RESULT: If only the C band is developed, the test indicates that nodetectable anti-Tp antibody is present in the specimen. The result is negative.2. POSITIVE RESULT: If both C and T bands are developed, the test indicates for thepresence of anti-Tp antibody in the specimen. The result is positive.3. A negative result for an individual subject indicates absence of detectable anti-Tpantibody. However, a negative test result does not preclude the possibility of exposureto or infection with Tp.4. A negative result can occur if the quantity of the anti-Tp antibody present in thespecimen is below the detection limits of the assay, or the antibodies that are detectedare not present during the stage of disease in which a sample is collected.5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoidfactor may affect expected results.6. The results obtained with this test should only be interpreted in conjunction with otherdiagnostic procedures and clinical findings.REFERENCES1. Centers for Disease Control and Prevention. Chlamydia trachomatis infections: policyguidelines from prevention and control. Morbid. Mortal. Weekly Rep. 1995; 34:53S-74S.2. Tichonova, L., K. Borisenko, H.Ward, A.meheus, et al. Epidemics of syphilis in theRussian Federation: Trends, origins, and priorities for control. Lancet 1997; 350:210-213.3. Gerbase, A. C., J. T. Rowley, D. H. Heymann, S. F. Berkley, and P. Piot. Globalprevalence and incidence estimates of selected curable STDs. Sex. Transm. Infect1998; 74:S12-S16.4. Luger AFH. Serological Diagnosis of Syphilis: Current methods. In: Young H, McMillanA, eds. Immunological diagnosis of sexually transmitted diseases. New York: MarcelDecker, 1988: 249-274.5. Baker-Zander SA, Hook EW 3rd, Bonin P, Handsfield HH, Lukehart SA. Antigens ofTreponema pallidum recognized by IgG and IgM antibodies during syphilis in humans. JInfect Dis. 1985; 151(2):264-72.6. Norgard MV, Chamberlain NR, Swancutt MA, Goldberg MS. Cloning and expression ofthe major 47-kilodalton surface immunogen of treponema pallidum in Escherichia Coli.Infect Immun 1986; 54:500-506.7. Purcell BK, Chamberlain NR, Goldberg MS, Andrews LP, Robinson EJ, Norgard MV,Radolf JD. Molecular cloning and characterization of the15-kilodalton major immunogenof Treponema pallidum. Infect Immun. 1989; 57(12):3708-148. Bailey MJ, Thomas CM, Cockayne A, Strugnell RA, Penn CW. Cloning and expressionof Treponema pallidum antigens in Escherichia coli. J Gen Microbiol 1989; 135 ( Pt9):2365-78.9. Sambri V, Marangoni A, Simone MA, D'Antuono A, Negosanti M, Cevenini R.Evaluation of recomWell Treponema, a novel recombinant antigen-based enzymelinkedimmunosorbent assay for the diagnosis of syphilis. Clin Microbiol Infect 2001;7(4):200-5.10. Rufli T. Syphilis and HIV infection. Dermatologica 1989; 179:113-117.Index of CE SymbolsConsultinstructions for useFor in vitrodiagnostic use onlyUse bySamples with positive results should be confirmed with alternative testing method(s) andclinical findings before a positive determination is made.REF Catalog # Lot NumberStore between 2-30°CManufacturerAuthorizedRepresentativeDate of manufactureNTests per kitDo not reuse3. INVALID: If no C band is developed, the assay is invalid regardless of color developmenton the T band as indicated below. Repeat the assay with a new device.CTK Biotech, Inc.10110 Mesa Rim RoadSan Diego, CA 92121, USATel: 858-457-8698Fax: 858-535-1739,E-mail: info@ctkbiotech.comCEpartner4UEsdoornlaan 13, 3951DB Maarn.The Netherlands. Tel.: +31 (0)6.516.536.261. Clinical PerformancePERFORMANCE CHARACTERISTICSA total of 300 patient samples from susceptible subjects were tested by the OnSiteSyphilis Ab Combo Rapid Test and by TPHA test (Serodia TP-PA, Fuji-rebio Inc.,Japan). Comparison for all subjects is shown in the following table.PI-R0031C Rev. BEffective date: 2011-05-10English versionFor Export Only, Not For Re-sale In the USAOnSite Syphilis Ab Combo Rapid TestTPPA Positive Negative TotalPositive 5 0 5Negative 5 290 295Total 10 290 300Relative Sensitivity: 100% , Relative Specificity: 98.3%, Overall Agreement: 98.3%2. PrecisionWithin run and between run precisions have been determined by testing 15 replicateswith three of the samples: a negative, a weak positive, and a strong positive sample.The negative, weaker positive, and strong positive samples were correctly identified inall of the tests each time.LIMITATIONS OF TEST1. The Assay Procedure and the Assay Result Interpretation must be followed closelywhen testing the presence of anti-Tp antibody in serum, plasma or whole blood fromindividual subjects. Failure to follow the procedure may give inaccurate results.2. The OnSite Syphilis Ab Combo Rapid Test is limited to the qualitative detection of anti-Tp antibody in human serum or plasma. The intensity of the test band does not linearcorrelation with the antibody titer in the specimen.