Urine samples, rectal swabs, and pharyngeal swabs were collected using cobas PCR urine sample kits and cobas PCR female swab collection kits (for pharyngeal and rectal swabs) and were tested for N. gonorrhoeae and C. trachomatis by NAAT on the cobas 4800 CT/NG v2.0 system (Roche Diagnostics, Branchburg, NJ, USA). Blood was collected for HIV testing and was performed on the ARCHITECT HIV Ag/Ab Combo (Abbott Laboratories, Wiesbaden, Germany). Serologic testing for syphilis was done using the Architect Syphilis TP assay (Abbott Laboratories, Wiesbaden, Germany), with positive samples undergoing rapid plasma reagin (RPR) testing (Spinreact, Barcelona, Spain or Monlab, Barcelona, Spain) and Treponema pallidum hemagglutination (TPHA), as indicated (Spinreact, Barcelona, Spain).
Architect syphilis tp assay
Manufactured by Abbott
Sourced in Germany
The Architect Syphilis TP assay is an automated immunoassay for the qualitative detection of antibodies to Treponema pallidum, the causative agent of syphilis, in human serum or plasma samples. The assay uses chemiluminescent microparticle immunoassay (CMIA) technology to provide results.
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Lab products found in correlation
Architect hiv ag ab combo, by Abbott (2 mentions)
Geenius hiv supplemental assay, by Bio-Rad (1 mentions)
Macro vue rpr, by BD (1 mentions)
Aptima combo 2 assay, by Hologic (1 mentions)
Sd bioline syphilis 3, by Standard Diagnostics (1 mentions)
Rpr nosticon 2, by bioMérieux (1 mentions)
New lav blot 1, by Bio-Rad (1 mentions)
Genscreen ultra hiv ag ab, by Bio-Rad (1 mentions)
New lav blot 2, by Bio-Rad (1 mentions)
Wampole impact rpr test kit, by Abbott (1 mentions)
Bioplex 2200 syphilis igg, by Bio-Rad (1 mentions)
7 protocols using architect syphilis tp assay
1
Molecular testing for STIs
2
Rapid Screening for HIV, Syphilis, and STIs
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Participants underwent rapid antibody testing for HIV (Advance Quality Anti-HIV 1&2; InTec Products, Inc) and syphilis (Advance Quality Anti-TP; InTec Products, Inc). Rapid test results were delivered to participants within ~ 20 min, and those whose rapid test results were positive underwent confirmatory HIV (Architect HIV Ag/Ab Combo; Abbott; Geenius™ HIV ½ Supplemental Assay; Bio-Rad;) and/or syphilis (rapid plasma reagin (RPR) test: BD Macro-Vue™ RPR; Becton, Dickinson and Company; Treponemal (TP) assay: Architect Syphilis TP assay; Abbott) testing. RPR and TP positive participants with titers ≥1:8 were considered active syphilis cases. Urine samples were collected to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections via nucleic acid amplification testing (Aptima Combo 2® Assay; Hologic). The San Diego County Public Health Laboratory conducted all nucleic acid amplification and confirmatory testing, the results of which were delivered to participants within approximately 1 month. STI-positive participants were offered free treatment according to Mexican STI treatment guidelines and HIV-positive participants were referred to municipal health clinics in Tijuana and Ciudad Juarez for free care and treatment.
3
Diagnostic Protocols for Syphilis Outbreaks
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During the first outbreak, finger prick blood was tested using rapid diagnostic assays. The SD Bioline Syphilis 3.0 (Standard Diagnostics Inc, Suwon, Korea) was used to determine the presence of treponemal antibodies, while the Dual Path Platform (DPP) Screen and Confirm Assay (Chembio Diagnostic Systems Inc, NY, USA) to confirm the presence of an active infection based on the simultaneous detection of both treponemal and non-treponemal antibodies.
Rapid diagnostic tests were not available during the second and third outbreak. Therefore venous blood was collected and tested using the Architect Syphilis TP Assay (Abbott Laboratories, Des Plaines, IL, USA), that detects treponemal antibodies. If positive, the serum was then tested by TPHA (Bio-Rad, Marnes-la-Coquette, France) to confirm the initial result and a non-treponemal test to confirm an active infection (RPR; RPR-nosticon II, BioMérieux, Marcy-l’Etoile, France).
Rapid diagnostic tests were not available during the second and third outbreak. Therefore venous blood was collected and tested using the Architect Syphilis TP Assay (Abbott Laboratories, Des Plaines, IL, USA), that detects treponemal antibodies. If positive, the serum was then tested by TPHA (Bio-Rad, Marnes-la-Coquette, France) to confirm the initial result and a non-treponemal test to confirm an active infection (RPR; RPR-nosticon II, BioMérieux, Marcy-l’Etoile, France).
4
Serological Screening for Syphilis and HIV
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Serum samples from all patients included in this study were tested using the RPR test (Bio-Rad, Marnes la Coquette, France) and Architect Syphilis TP assay (Abbott Laboratories, Abbott Park, Green Oaks, IL, USA) according to the manufacturers’ instructions.
HIV-1 and HIV-2 antigens and antibodies detection in serum was performed in routine by an automated ELISA assay (Genscreen ULTRA HIV Ag-Ab®; Bio-Rad, Marne-la-Coquette, France) according to the manufacturers’ instructions. Positive detection of antibodies was confirmed by HIV-1 and HIV-2 immunoblottings (NEW Lav-Blot I and NEW Lav-Blot II; Bio-Rad, Marne-la Coquette, France).
HIV-1 and HIV-2 antigens and antibodies detection in serum was performed in routine by an automated ELISA assay (Genscreen ULTRA HIV Ag-Ab®; Bio-Rad, Marne-la-Coquette, France) according to the manufacturers’ instructions. Positive detection of antibodies was confirmed by HIV-1 and HIV-2 immunoblottings (NEW Lav-Blot I and NEW Lav-Blot II; Bio-Rad, Marne-la Coquette, France).
5
Evaluation of Elecsys Syphilis Assay
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Each center evaluated the Elecsys Syphilis assay and at least one of the following treponemal comparator assays: Architect Syphilis TP assay (Abbott Laboratories, Wiesbaden, Germany), Liaison Treponema Screen assay (DiaSorin, Saluggia, Italy), Serodia T. pallidum particle agglutination (TPPA) assay (Fujirebio, Tokyo, Japan), and Mediace T. pallidum latex agglutination (TPLA) assay (Sekisui Medical, Tokyo, Japan). All comparator assays were performed according to the manufacturers' instructions. In Milan, the Architect Syphilis TP assay was used to initially characterize samples that were later retested with the Elecsys Syphilis assay; therefore, this was not a simultaneous comparator assay.
6
Syphilis Diagnosis Protocol Evaluation
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Twenty-three laboratories in Quebec participated to this study. Four recombinant antigens-based TT were used: a chemiluminescence immunoassays (Architect Syphilis TP assay; Abbott Laboratories) two enzyme immunoassays (Syphilis EIA II Total Antibody assay; Bio-Rad Laboratories, Trep-Sure Syphilis Total Antibody EIA; Trinity BioTech), and a multiplex flow immunoassay (Bioplex 2200 Syphilis IgG; Bio-Rad Laboratories). Three nontreponemal test were also used in this study: Macro-Vue RPR Card Test from Becton-Dickinson, RPR Carbon Antigen Test from Pulse Scientific and Wampole Impact RPR Test kit from Alere.
All TT and NTT were performed according to the manufacturer’s recommendations. Architect TP, Bioplex IgG and Syphilis EIA-II kits express the results as a S/CO index with a cut-off at 1.00. Trep-Sure expresses the results as an optical density (OD) with a variable cut-off. In order to standardize the expression of all results, the Trep-Sure OD results were converted into S/CO ratios with a cut-off of 1.00.
All results were expressed as normalized S/CO ratios obtained by measuring the signal strength of sample and the signal strength of an internal cutoff. Samples with an S/CO ratio of ≥1.0 are defined as positive according to the manufacturers.
All TT and NTT were performed according to the manufacturer’s recommendations. Architect TP, Bioplex IgG and Syphilis EIA-II kits express the results as a S/CO index with a cut-off at 1.00. Trep-Sure expresses the results as an optical density (OD) with a variable cut-off. In order to standardize the expression of all results, the Trep-Sure OD results were converted into S/CO ratios with a cut-off of 1.00.
All results were expressed as normalized S/CO ratios obtained by measuring the signal strength of sample and the signal strength of an internal cutoff. Samples with an S/CO ratio of ≥1.0 are defined as positive according to the manufacturers.
7
Syphilis Screening and Testing Protocol in Greenland
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In Greenland, indications for testing for T. pallidum infection include clinical suspicion of syphilis, primary contacts to syphilis cases, and certain patient groups (pregnant women, persons investigated for dementia, patients admitted to psychiatric ward, HIV positives, and occasionally, patients admitted for surgery). Since 2009, a chemiluminescent microparticle immunoassay detecting antibodies to T. pallidum (ARCHITECT Syphilis TP assay Abbott Laboratories; Abbott Park, IL) has been performed on blood samples at the Central Laboratory at the Queen Ingrid's Hospital, as a screening test for syphilis. If positive (≥1 S/CO), the sample is forwarded to Statens Serum Institut (SSI) in Copenhagen, Denmark, for further serological testing with nontreponemal Wassermann reaction (WR), rapid plasma reagin (RPR), and treponemal antiflagellum IgM and IgG antibodies (AF-IgM and AF-IgG). Thus, the reverse algorithm for syphilis serology testing is used.13 Serological analyses of spinal fluid and PCR analysis for T. pallidum infection in skin and mucosal lesions are also performed at the SSI. All syphilis laboratory results for Greenland from 2007 and onward, including those from the SSI, can be accessed in the national laboratory database.
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