Gene/Protein Disease Symptom Drug Enzyme Compound
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The aim of this study was to evaluate Enzywell TP, a new rapid enzyme immunoassay (EIA) that uses 2 recombinant Treponema pallidum antigens for the serological diagnosis of syphilis. Specificity was evaluated by screening 1055 unselected bloods requesting serological tests for syphilis in parallel with Enzywell TP and the Syphilis ICE EIA which is our standard screening test for syphilis. Sensitivity was evaluated using a panel of 159 known treponemal sera representing various stages of syphilis and 5 treponemal sera detected on screening. The specificity of Enzywell TP on initial and repeat testing (99.6% and 99.7% respectively) was similar to that of the Syphilis ICE test (99.8% and 99.9% respectively). The sensitivity of Enzywell TP (100%) was similar to that of Syphilis ICE (99.4%): both tests were significantly more sensitive (P=0.01) than the fluorescent antibody absorbed test (94.5%) but not the T. pallidum particle agglutination (TPPA) assay (99.4%). Both Enzywell TP and Syphilis ICE were positive with sera from 16 known HIV-infected patients who had been treated for syphilis many years previously (mean 9.4 years) confirming the value of these tests in excluding previous syphilis in HIV-infected individuals. We conclude that the Enzywell recombinant EIA is simple, rapid, highly sensitive and specific, and is a welcome addition to the range of currently available diagnostic tests for syphilis.
Int J STD AIDS 2000 May
PMID:Enzywell recombinant enzyme immunoassay for the serological diagnosis of syphilis. 1082 36

This study was conducted to determine the significance of an isolated positive (where all other syphilis serology is negative) syphilis enzyme immunoassay (EIA) test (ICE syphilis: Murex Diagnostics) in a sexual health clinic population. There were significantly greater numbers of isolated positive syphilis EIA tests at Sydney Sexual Health Centre (SSHC) (22/5478) compared to lower risk populations; Southeastern Sydney antenatal clinics (1/11,560, P<0.01) and Sydney Children's Hospital (0/3550, P<0.01). We conducted a case control study comparing the cases at SSHC with two control groups drawn from the clinic population. A manual review of the case medical records searched for a history of suggested syphilis. Within the 22 cases, 32% had clinical grounds for suspecting that the EIA test signified syphilis. Men reporting homosexual contact in the past 12 months significantly distinguished cases from controls who tested negative for syphilis (OR=6.06). An isolated positive EIA test should prompt further investigation for syphilis, past or present.
Int J STD AIDS 2002 Nov
PMID:Investigation of isolated positive syphilis enzyme immunoassay (ICE Murex) results. 1243 96

We evaluated the Treponema pallidum haemagglutination assay (TPHA), a treponemal test, with three other treponemal tests, the Serodia T. pallidum particle agglutination assay, the Murex Syphilis ICE IgG + IgM enzyme immunoassay (EIA) and the Enzywell TP IgG + M EIA (a new rapid EIA) for use in conjunction with the rapid plasma reagin test (RPR), a non-treponemal test, for serodiagnosis of syphilis. In all, 124 serum samples were found reactive with RPR and/or TPHA after testing by the routine laboratory protocol. Twenty-three (18.5%) of them were positive only by RPR test and were evaluated as biologically false-positive, 16 were positive only by the TPHA and 84 by both the RPR and TPHA tests; one sample was non-specific (heterophile reaction) in the TPHA. Agreements of the TPHA with the Serodia TPPA, the Murex Syphilis ICE and the Enzywell TP tests were 96.7%, 100% and 99.1%, respectively. We conclude that each one of the tests, the Serodia TPPA, the Murex Syphilis ICE and the Enzywell TP, is an appropriate substitute for screening for serodiagnosis of syphilis.
Int J STD AIDS 2005 Apr
PMID:Evaluation of the serodia Treponema pallidum particle agglutination, the Murex Syphilis ICE and the Enzywell TP tests for serodiagnosis of syphilis. 1589 82

Our aim was to determine the sensitivity of the Murex ICE enzyme immunoassay (EIA) as a screening test for early syphilis and to determine how many additional cases of infection were detected by performing additional tests when requested on clinical grounds. This was an observational study on consecutive patients diagnosed with syphilis in the Department of Genitourinary Medicine, Edinburgh between January 1st 2004 and April 1st 2005. Additional tests were performed on sera that gave a positive or equivocal EIA on screening as well as by clinical request on sera from contacts of syphilis, and those with clinical signs of syphilis. Additional tests included a Venereal Diseases Research Laboratory (VDRL) carbon antigen test, a Treponema pallidum particle agglutination (TPPA) test, INNO-LIA line immunoblot assay, and an EIA specific for anti-treponemal IgM.A total of 105 patients were diagnosed with syphilis: primary (50), secondary (26), early latent (8), and of unknown duration (21). The TPPA was the most sensitive test in primary syphilis and had a sensitivity of 96% (48/50), which was significantly higher (P <0.05) than the sensitivity of 84% (42/50) for the screening EIA: seven of the EIA negatives were detected by EIA-IgM, six by TPPA, five by immunoblot, and two by VDRL. EIA-IgM was negative in six primaries; all were positive by TPPA and immunoblot. We conclude that, in order to maximize the serological detection of primary syphilis a specific EIA-IgM test and a TPPA test should be performed whenever there is a clinical suspicion of primary infection. This is particularly important when an EIA such as Murex ICE is used as a single screening test as it is less sensitive than the TPPA in primary infection.
Int J STD AIDS 2006 Nov
PMID:The sensitivity of syphilis assays in detecting different stages of early syphilis. 1706 83

We compared the fluorescent treponemal antibody-absorption (FTA-ABS) (immunoglobulin (Ig)G + IgM) assay with the (micro-) Treponema pallidum haemagglutination assay (TPHA), the T. pallidum particle agglutination assay (TPPA), the Murex syphilis ICE (ICE) enzyme-linked immunosorbent assay (ELISA), the Diesse Enzywell TP (TP) (ELISA) using 122 serum samples and the Western blot (WB) assay using 42 serum samples whose results were inharmonious with other tests. Additionally, the Captia syphilis-M (IgM) (ELISA) were performed. All sera had already been examined by the rapid plasma reagin (RPR) card test, a non-treponemal test and the TPHA, a treponemal test using routine screening tests. Agreements of the FTA-ABS with the TPHA test, the TPPA test, the ICE test and the TP test were 97.5%, 95.9%, 98.3% and 98.3%, respectively. The results suggest that the FTA-ABS test is a useful confirmatory test, but can be inadequate as a confirmatory test for serologic diagnosis of syphilis by giving equivocal and false-negative results even rarely.
Int J STD AIDS 2007 Apr
PMID:Evaluation of the fluorescent treponemal antibody absorption test for detection of antibodies (immunoglobulins G and M) to Treponema pallidum in serologic diagnosis of syphilis. 1750 77

We evaluated the performance of two immunoblot assays: the INNO-LIA Syphilis Score (LIA) and the MarDx T. pallidum IgG Marblot Test (TWB), as compared with that of the Murex ICE Syphilis enzyme immunoassay (EIA), the Serodia Treponema pallidum particle agglutination (TPPA) assay and the fluorescent treponemal antibody-absorption (FTA-abs) assay, for the serological diagnosis of syphilis using serum samples of 135 attendees of the social hygiene clinics of the Department of Health in Hong Kong newly diagnosed with syphilis and provided with clinical stages (39 in primary, 20 in secondary, 18 in early latent and 58 in latent of unknown duration) and of 43 normal healthy subjects between October and December 2004. The differences in the overall sensitivities of the LIA assay and the EIA/TPPA/FTA-abs assays were not statistically significant (P > 0.05) whereas the overall sensitivity of the TWB assay was significantly lower (P < 0.05) than the overall sensitivities of the EIA, the TPPA and the FTA-abs assays. The LIA assay had an overall sensitivity of 94.1% (95% CI 88.7-97.0%) whereas the TWB assay 65.2% (95% CI 56.8-72.7%). Both the LIA and the TWB assays have a specificity of 100%. When consensus results were derived from the most predominant results of the EIA, the TPPA and the FTA-abs assays, the LIA assay had a positive agreement with the consensus results of 98.5% (95% CI 94.5-99.6%) whereas the TWB assay 68.2% (95% CI 59.8-75.6%). Therefore, the LIA assay performed significantly better (P < 0.05) than the TWB assay. The LIA assay can be considered to be a valid alternative confirmatory test for the serological diagnosis of syphilis.
Int J STD AIDS 2010 Feb
PMID:Comparative evaluation of the INNO-LIA syphilis score and the MarDx Treponema pallidum immunoglobulin G Marblot test assays for the serological diagnosis of syphilis. 2008 96

We studied the use of the INNO-LIA syphilis score assay in the resolution of discordant positive screening results of the Murex ICE Syphilis enzyme immunoassay (EIA) with the confirmatory results of both the Serodia Treponema pallidum particle agglutination (TPPA) and the fluorescent treponemal antibody-absorption (FTA-Abs) assays, for the serological diagnosis of syphilis. This was an observational study on the serum samples received by the Syphilis Laboratory, Hong Kong, during the period from January 2006 to December 2012. A total of 801 serum samples with discordant positive screening EIA results were used. Consensus results of such serum samples were derived from results of the EIA, TPPA and FTA-abs assays. The age range of the individuals was 14 to 104 years (median of 52). There were 369 males and 432 females. Of 378 serum samples, 139 showed agreement among positive results, 23 of 310 showed agreement among indeterminate results and 277 of 465 showed agreement among negative results. The proportions of agreement among positive, indeterminate and negative results were 0.37 (95% CI 0.32-0.42), 0.07 (95% CI 0.05-0.11) and 0.60 (95% CI 0.55-0.64), respectively; kappa 0.55 (95% CI 0.49-0.60). There were 60 serum samples with positive consensus results but negative INNO-LIA syphilis score results and 10 with negative consensus results but positive INNO-LIA syphilis score results. Although the INNO-LIA syphilis score assay can be considered a valid alternative confirmatory test for the serological diagnosis of syphilis, the present study showed that its use in the resolution of discordant positive screening EIA results was moderate. A more extensive characterization of serum samples with discordant reactive screening treponemal test results is necessary.
Int J STD AIDS 2014 Jan
PMID:Use of the INNO-LIA syphilis score assay in the resolution of discordant positive screening enzyme immunoassay results for the serological diagnosis of syphilis. 2397 Jun 31