Evaluation of the HISCL Anti-Treponema pallidum Assay as a Screening Test for Syphilis

An, Jingna; Chen, Qixia; Liu, Qianqian; Rao, Chenli; Li, Dongdong; Wang, Tingting; Tao, Chuanmin; Wang, Lanlan

doi:10.1128/cvi.00116-15

Cited by 9 publications

(7 citation statements)

References 23 publications

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“…et al (16) screened 13,767 serum samples from 13 centers in China and obtained a sensitivity of 100% and a specificity of 99.81% for Elecsys in detecting anti-TP. Similar data on sensitivity and specificity of HISCL was reported by An et al(17). Elecsys anti-HCV II assay showed a sensitivity of 100% and a specificity of 99.66% in 7,726 routine samples from the Asia-Pacific region(18), while research by Feng et al(19) revealed that HISCL anti-HCV assay had a sensitivity of 98.97% and specificity of 100% in 1,048 samples from China.…”

supporting

confidence: 75%

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Tong

2019

Ann. Transl. Med.

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Background: We conducted a comprehensive comparison in the sensitivity, specificity, dilution sensitivity, and precision between two immunoassay systems, Roche Elecsys Cobas e 601 and Sysmex HISCL 5000, for the detection of hepatitis B virus surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV), treponemal antibodies (anti-TP), and human immunodeficiency virus (HIV). Methods: One thousand unselected samples and 100 reserved weak reactive samples were tested by the two systems. Sensitivity and specificity were then calculated for each system. Seroconversion panels were used to assess the sensitivity in early stage detection. Dilution sensitivity was evaluated by dilution tests of several seroconversion panel samples. Evaluation of within-run and intermediate precision was conducted following EP-15A protocol. Results: The consistency rates of the two systems for the detection of four pathogens were all over 99% among unselected samples. Both Elecsys and HISCL were observed to have high sensitivity and specificity in unselected samples and weak reactive samples. Seroconversion panel tests showed that Elecsys could identify positive results earlier than HISCL in HBsAg (1 out of 4), anti-TP (1 out of 2) and HIV (1 out of 12) panels. The results of the anti-HCV panels were comparable. In dilution tests, Elecsys could detect lower concentrations than HISCL in two anti-HCV samples and one anti-TP sample. The two systems had similar performance in dilution tests of HBsAg and HIV samples. Both Elecsys and HISCL had qualified intra-assay and inter-assay precision. Conclusions: Both Elecsys and HISCL have good performance in the screening of four common bloodborne pathogens. The two systems are comparable and considered adequate for clinical use.

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confidence: 75%

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Tong

2019

Ann. Transl. Med.

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“…The automated Lumipulse G TP-N assay was cleared in July 2016 by the U.S. Food and Drug Administration (FDA) as an aid in the diagnosis of syphilis. To our knowledge, this is the only study comparing the Lumipulse G TP-N assay to another automated, FDA-cleared assay (17)(18)(19). A total of 4,034 serum samples routinely submitted for syphilis screening and samples from 100 high-risk HIV patients were tested by the Lumipulse G TP-N assay and the Bioplex 2200 Syphilis IgG assay.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Lumipulse G TP-N Chemiluminescent Immunoassay as a Syphilis Screening Test

Ortiz

Loeffelholz

2017

J Clin Microbiol

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A syphilis diagnosis is often aided by the detection of treponemal and nontreponemal antibodies. Automated treponemal antibody detection systems enable high-volume clinical laboratories to perform syphilis screening at a faster pace with lower labor costs. The Lumipulse G TP-N chemiluminescent immunoassay is an automated system that qualitatively detects IgG and IgM antibodies against antigens in human serum and plasma. To assess performance characteristics and workflow efficiency, the Lumipulse G TP-N assay was compared to the Bioplex 2200 Syphilis IgG multiplex flow immunoassay. Among the 4,134 routine and HIV samples tested by the two automated assays, the percentage of agreement was excellent at 99.0% (95% confidence interval [CI], 98.6% to 99.2%; κ, 0.89), with the Lumipulse G TP-N having a shorter time to first and subsequent results. All specimens with reactive syphilis screening results were further tested by rapid plasma reagin (RPR) and particle agglutination (TP·PA) testing ( = 231). The results from the RPR-reactive samples ( = 82) showed complete concordance with the two automated assays, while the TP·PA assay displayed some discrepancies. The positive percent agreement (PPA) and negative percent agreement (NPA) between the TP·PA test and the Lumipulse G TP-N test were 98.9% and 77.3%, respectively. The Bioplex 2200 Syphilis IgG immunoassay displayed a similar PPA (100%) but a substantially lower NPA (15.9%). Patient chart reviews of discrepant results suggested that the Lumipulse G TP-N assay produced 27 fewer falsely reactive results and can reduce the amount of additional confirmatory RPR and TP·PA testing needed. The analogous performance characteristics of the two automated systems indicate that the Lumipulse G TP-N assay is suitable for high-throughput syphilis screening.

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“…In conclusion, this may be the first report of a patient with syphilitic femoral artery aneurysm who was successfully treated by combined open and endovascular repair. However, this study has some limitations, such as the shorter follow-up time, the treponeme not identified in the removed tissues, and the syphilis confirmed only by RPR and Treponema pallidum hemagglutination antibody assay, not including other tests, such as venereal disease research laboratory (VDRL), treponemal pallidum particle agglutination (TPPA), fluorescence test assay absorption (FTA-ABS), the enzyme immunoassay (EIA) or the chemiluminescent immunoassay (CLIA) [ 21 ]. Thus, case series studies are needed to provide the systematic diagnosis and treatment recommendation for syphilitic femoral artery aneurysm.…”

Section: Discussionmentioning

confidence: 99%

Surgical treatment of syphilitic superficial femoral artery aneurysm: a rare case report

et al. 2015

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BackgroundArterial aneurysm is a known complication of syphilis, but the occurrence of femoral artery aneurysm secondary to the syphilitic disease has never been reported.Case presentationThe present study described a 60-year-old Chinese male who presented with two aneurysms in the middle and lower segment of the right superficial femoral artery causing the symptoms of pain, coldness and numbness in the right lower limb. This case was diagnosed with syphilitic superficial femoral aneurysm because of positive syphilitic testing and the inflammatory cell infiltration around the adventitial vasa vasorum under the pathological examination. Anti-syphilis treatment, stent graft implantation and open surgery were attempted to eliminate the syphilis and aneurysm, which was ultimately successful, with no symptoms after a follow-up of 3 months.ConclusionCombined open and endovascular repair may be effective and safe for treatment of syphilitic femoral artery aneurysms.

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Evaluation of the HISCL Anti-Treponema pallidum Assay as a Screening Test for Syphilis

Cited by 9 publications

References 23 publications

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Comparison of Roche Elecsys and Sysmex HISCL immunoassays for the screening of common blood-borne pathogens

Evaluation of the Lumipulse G TP-N Chemiluminescent Immunoassay as a Syphilis Screening Test

Surgical treatment of syphilitic superficial femoral artery aneurysm: a rare case report

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