Establishment and Evaluation of a One‐Step Microplate Chemiluminescence Immunoassay to Detect IgG Antibody Against <i>Treponema Pallidum</i>

Liu, Lijuan; Xie, Yuling; Dai, Z.; Zhuo, Chuanshang; Wu, Yuping

doi:10.1002/jcla.21799

Cited by 2 publications

(3 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As T. pallidum cannot be cultured in vitro, the serological detection of specific antibodies against T. pallidum is of particular importance (4,8,9). Serologic tests often fall into two categories: nontreponemal and treponemal assays.…”

mentioning

confidence: 99%

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

Chen

Liu

et al. 2015

Clin Vaccine Immunol

View full text Add to dashboard Cite

The resurgence of syphilis in recent years has become a serious threat to public health worldwide, and the serological detection of specific antibodies against Treponema pallidum remains the most reliable method for laboratory diagnosis of syphilis. This study examined the performance of the recently launched HISCL anti-Treponema pallidum (anti-TP) assay as a screening test for syphilis in a high-volume laboratory. The HISCL anti-TP assay was tested in 300 preselected syphilis-positive samples, 704 fresh syphilis-negative samples, 48 preselected potentially interfering samples, and 30 "borderline" samples and was compared head to head with the commercially available Lumipulse G TP-N. In this study, the HISCL anti-TP assay was in perfect agreement with the applied testing algorithms with an overall agreement of 100%, comparable to that of Lumipulse G TP-N (99.63%). The sensitivity and specificity of the HISCL anti-TP assay were 100% (95% confidence interval [CI], 98.42% to 100%) and 100% (95% CI, 99.37% to 100%), respectively. Considering the excellent ease of use and automation, high throughput, and its favorable sensitivity and specificity, the HISCL anti-TP assay may represent a new choice for syphilis screening in high-volume laboratories.

show abstract

mentioning

confidence: 99%

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

Chen

Liu

et al. 2015

Clin Vaccine Immunol

View full text Add to dashboard Cite

show abstract

“…There is a clear need for new diagnostic methods and effective diagnostic algorithms for screening (1,(4)(5)(6). Many comparative studies on this subject have suggested that there are many advantages of using a reverse algorithm, in which the screening starts with a treponemal test (7)(8)(9)(10)(11). The use of treponemal immunoassays for syphilis screening eliminates biologically false positives due to the presence of anticardiolipin antibodies in certain diseases (12)(13)(14).…”

Section: Resultsmentioning

confidence: 99%

“…In comparative studies conducted with the CLIA method, it is stated that having high sensitivity and specificity, lower labor costs and faster results, CLIA can be effectively used for screening in laboratories with high sample counts, and it is emphasized that false positive CLIA results can be confirmed by a treponemal test, such as TPHA and TPPA (7,8,10,11).…”

Section: Resultsmentioning

confidence: 99%

The evaluation of the reverse algorithm for syphilis screening in blood donors

Berkem

Karakoç

2019

Revista Romana De Medicina De Laborator

View full text Add to dashboard Cite

Background: In Turkey, prior to transfusion and apheresis, it is mandatory to screen blood for HBsAg, anti-HCV, anti-HIV 1/2, and syphilis. In recent years, efforts have been made to create effective diagnostic algorithms for screening, and as a screening strategy, many countries have switched from traditional algorithms to reverse algorithms. This study was carried out to evaluate the results we obtained after changing to chemiluminescence immunoassay (CLIA) based reverse algorithm, which is more sensitive and specific than the traditional algorithm and VDRL test we currently use for syphilis screening. Methods: The screening algorithm was initiated with the treponemal CLIA method. The reactive samples were tested using a nontreponemal test VDRL and a second treponemal test TPHA. In the descriptive analyses, the averages, numbers, and percentage distributions were calculated. The group comparisons were undertaken with the chi-square test, accepting p < 0.05 as statistically significant. Results: Of the 5,053 samples that were tested with CLIA syphilis TPA assay 5,043 were negative (99.802%) and 10 were positive reactive (0.198%), and the difference between the two was statistically significant (p < 0.001). Ten samples that were recurrently reactive were analyzed by VDRL and TPHA tests simultaneously. VDRL was negative in all 10 samples, whereas TPHA was negative in one sample, but positive in nine samples at a titer of ≥1/160. Conclusion: Based on the results of this study, we decided to use the CLIA method and reverse algorithm instead of using the traditional algorithm and VDRL as the initial screening method.

show abstract

Establishment and Evaluation of a One‐Step Microplate Chemiluminescence Immunoassay to Detect IgG Antibody Against Treponema Pallidum

Abstract: The established rapid, specific, sensitive, and stable microplate CLIA method to detect IgG antibody against T pallidum will provide an efficient alternative to the treponemal tests and wide application in clinical laboratory.

Cited by 2 publications

References 14 publications

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

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

The evaluation of the reverse algorithm for syphilis screening in blood donors

Contact Info

Product

Resources

About