Tags

Type your tag names separated by a space and hit enter

Evaluation of the BioPlex 2200 syphilis total screen (IgG/IgM) with reflex to an automated rapid plasma reagin test.
J Clin Lab Anal. 2019 Jun; 33(5):e22878.JC

Abstract

BACKGROUND

We evaluated the recently FDA cleared BioPlex 2200 Syphilis Total Screen and automated rapid plasma reagin (RPR) assay for the detection of total (IgG/IgM) treponemal and non-treponemal antibodies in the reverse syphilis algorithm.

METHODS

Prospectively submitted samples (n = 885) were assayed by both the IgG/IgM BioPlex Syphilis Screen and the original IgG BioPlex Syphilis Screen. The IgG screen reactive samples were reflexed to traditional RPR, and IgG/IgM screen reactive samples were reflexed to the automated RPR. Nonreactive RPR samples were tested by the Treponemal Pallidum Particle Agglutination test (TP-PA). Additional samples were collected (n = 404 total samples) to directly compare the automated and traditional RPR assays with each other.

RESULTS

The sensitivity and specificity of the IgG/IgM screen with automated RPR was 95.6% (95% confidence interval [CI] 87.0-99.1) and 99.6% (CI 99.2-99.8) while the sensitivity and specificity of the BioPlex IgG screen with traditional RPR was 97.8% (CI 89.1-99.9) and 99.3% (CI 98.8-99.4). The sensitivity and specificity of the BioPlex RPR compared with traditional RPR was 95.8% (CI 93.9-97.0) and 94.1% (CI 89.4-91.1) and 95.3% (CI 92.6-97.1). The mean of the titer differences between the BioPlex RPR and the traditional RPR was 1.0 ± 0.9 SD titers.

CONCLUSION

The addition of the detection of treponemal IgM antibodies to the IgG/IgM screen did not significantly affect the sensitivity and specificity compared to the original IgG screen. However, the addition of the comparable BioPlex RPR assay to the instrumentation significantly reduces the overall labor of syphilis screening and confirmation.

Authors+Show Affiliations

Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina.Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

30861169

Citation

Rourk, Angela R., and Christine M. Litwin. "Evaluation of the BioPlex 2200 Syphilis Total Screen (IgG/IgM) With Reflex to an Automated Rapid Plasma Reagin Test." Journal of Clinical Laboratory Analysis, vol. 33, no. 5, 2019, pp. e22878.
Rourk AR, Litwin CM. Evaluation of the BioPlex 2200 syphilis total screen (IgG/IgM) with reflex to an automated rapid plasma reagin test. J Clin Lab Anal. 2019;33(5):e22878.
Rourk, A. R., & Litwin, C. M. (2019). Evaluation of the BioPlex 2200 syphilis total screen (IgG/IgM) with reflex to an automated rapid plasma reagin test. Journal of Clinical Laboratory Analysis, 33(5), e22878. https://doi.org/10.1002/jcla.22878
Rourk AR, Litwin CM. Evaluation of the BioPlex 2200 Syphilis Total Screen (IgG/IgM) With Reflex to an Automated Rapid Plasma Reagin Test. J Clin Lab Anal. 2019;33(5):e22878. PubMed PMID: 30861169.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the BioPlex 2200 syphilis total screen (IgG/IgM) with reflex to an automated rapid plasma reagin test. AU - Rourk,Angela R, AU - Litwin,Christine M, Y1 - 2019/03/12/ PY - 2019/01/08/received PY - 2019/02/14/revised PY - 2019/02/16/accepted PY - 2019/3/13/pubmed PY - 2019/3/13/medline PY - 2019/3/13/entrez KW - Treponema pallidum KW - TP-PA KW - rapid plasma reagin KW - syphilis SP - e22878 EP - e22878 JF - Journal of clinical laboratory analysis JO - J. Clin. Lab. Anal. VL - 33 IS - 5 N2 - BACKGROUND: We evaluated the recently FDA cleared BioPlex 2200 Syphilis Total Screen and automated rapid plasma reagin (RPR) assay for the detection of total (IgG/IgM) treponemal and non-treponemal antibodies in the reverse syphilis algorithm. METHODS: Prospectively submitted samples (n = 885) were assayed by both the IgG/IgM BioPlex Syphilis Screen and the original IgG BioPlex Syphilis Screen. The IgG screen reactive samples were reflexed to traditional RPR, and IgG/IgM screen reactive samples were reflexed to the automated RPR. Nonreactive RPR samples were tested by the Treponemal Pallidum Particle Agglutination test (TP-PA). Additional samples were collected (n = 404 total samples) to directly compare the automated and traditional RPR assays with each other. RESULTS: The sensitivity and specificity of the IgG/IgM screen with automated RPR was 95.6% (95% confidence interval [CI] 87.0-99.1) and 99.6% (CI 99.2-99.8) while the sensitivity and specificity of the BioPlex IgG screen with traditional RPR was 97.8% (CI 89.1-99.9) and 99.3% (CI 98.8-99.4). The sensitivity and specificity of the BioPlex RPR compared with traditional RPR was 95.8% (CI 93.9-97.0) and 94.1% (CI 89.4-91.1) and 95.3% (CI 92.6-97.1). The mean of the titer differences between the BioPlex RPR and the traditional RPR was 1.0 ± 0.9 SD titers. CONCLUSION: The addition of the detection of treponemal IgM antibodies to the IgG/IgM screen did not significantly affect the sensitivity and specificity compared to the original IgG screen. However, the addition of the comparable BioPlex RPR assay to the instrumentation significantly reduces the overall labor of syphilis screening and confirmation. SN - 1098-2825 UR - https://www.unboundmedicine.com/medline/citation/30861169/Evaluation_of_the_BioPlex_2200_syphilis_total_screen__IgG/IgM__with_reflex_to_an_automated_rapid_plasma_reagin_test_ L2 - https://doi.org/10.1002/jcla.22878 DB - PRIME DP - Unbound Medicine ER -