Syphilis point-of-care tests

Key Question

What serologic-based point-of-care (POC) tests are available to support a syphilis diagnosis, including single syphilis POC tests and combination syphilis/HIV and nontreponemal/treponemal POC tests, and what are the performance characteristics?

Literature Search Terms

(syphilis OR Treponema pallidum) AND (Syphilis Health Check OR rapid test OR point-of-care test OR point of care test OR POC test OR rapid point-of-care test OR rapid point of care test OR RPOC test OR diagnostic test OR combination test OR dual test OR multiplex test OR ASSURED OR rapid syphilis test OR RST OR saliva test OR immunochromatographic test OR finger-stick test). Solely-based international studies were excluded from the literature search.

Grading

Four reviewers the evidence as high, medium, and low based on each study’s strengths and weaknesses. Case reports or small case studies were reviewed.

High quality publications: Studies using clinically characterized specimens, stratified by stage, larger sample size, prospective or a well-done cross sectional or retrospective study. Studies with large sample sizes, clinically characterized but not stratified by stage, or characterized but unclear exactly how it was done.

Medium quality publications: Studies with small sample sizes, moderate methodological issues, single lab test as gold standard, or descriptive.

Low quality publications: Studies with major methodological issues or small sample sizes.

I: Case reports or small case studies.

NR: Studies that were not relevant to the key question were assigned and not further rated.

Key Question 7
Citation Description of study type, design, population, and setting Reported findings, quantitative results related to key question Overall quality; strengths/weaknesses or limitations Relevance to the key question and/or overall importance Rank
Nakku-Joloba, E., et al. (2016). “Clinical Evaluation of 2 Point-of-Care Lateral Flow Tests for the Diagnosis of Syphilis.” Sex Transm Dis 43(10): 623-625.

 

Comparison of Syphilis Health Check (SHC) and SD Bioline (SDB) vs. TPHA and with traditional algorithm.

Uganda STD & ANC clinics from 2/12 to 6/13 totaling 215 patients.

The sensitivity of the Syphilis Health Check (Trinity Biotech)

against the TPHA reference standard was 89.8% (95% confidence

interval [95% CI], 82.0–95.0) and the specificity of the test was 92.3% (95% CI, 85.9–96.4).

 

We found that the SD Bioline rapid test, a

WHO prequalified POC treponemal syphilis test, had a higher

sensitivity than the Syphilis Health Check test (91.8%) but

had a lower specificity (82.9%) compared with the Syphilis

Health Check when the TPHA test was used as a reference standard.

Small sample size with limited data to make comparisons. Gold standard used was TPHA and examined use of tests in traditional algorithm. ***One of few articles found that have published data on the SHC. Good comparison study, although with limited sample size. Good real world data presented as POC testers utilized. Medium
Goza, M et al (2014). Syphilis Screening: A Review of the Syphilis Health Check Rapid immunochromatographic Test Immunodeficiency Virus. Journal Pharm technology. 33(2) 53-59. Took data from SHC package insert and presented in article. Focus of article is for pharmacists to conduct syphilis testing with SHC along with rapid HIV test. All data taken from clinical trials data from package insert. Data from article are poor since they all came from the FDA approval letter and package insert. No other data were presented. *Poor relevance since no actual data are presented outside of package insert. NR
Matthias J, D. P., Totten Y, Blackmore C, Wilson C, Peterman TA. (2016). “Notes from the Field. Evaluation of the Sensitivity and Specificity of a Commercially Available Rapid Syphilis Test — Escambia County, Florida, 2016.” MMWR Morb Mortal Wkly Rep 2016 65: 1174-1175.

 

FL DOH evaluation of SHC vs. RPR/Trep-Sure at STD clinic in Escambia County. 202 patients were screened with SHC and all had Trep-Sure conducted. Sens/Spec/PPA calculated for study.

Gold standard = Trep-Sure

Total N = 202

 

171 (85%) = non-reactive on all tests (RPR, SHC, Trep-Sure)

 

26 (13%) = SHC reactive

10/26 (38%) = Trep-Sure reactive (6=RPR +)

16 (62%) = RPR/Trep-Sure negative

5 (2%) = SHC non-reactive with discordant lab test

 

6/26 = all 3 tests +

3 = secondary

1 = primary

1 = early latent

1 = previously treated (no increase in titer)

 

Sens = 71.4% vs. TS

Spec = 91.5%

Overall agreement = 90.1%

 

Best comparison published to date

 

Limited # of patients studied

 

TS was gold-standard and no description about follow-up of patients.

 

Retrospective study design, therefore no follow-up could occur.

**Lower than expected Sens/Spec for SHC, but very limited population.

 

There was no description of a QA program – trainings, PT, QC, etc., which all may affect test results.

Medium
Performance of the Syphilis Health Check™ in a CLIA-waived and laboratory setting in North Carolina, USA.

Authors: Yetunde F. Fakile1, Myra Brinson2, Victoria Mobley3, Anne M. Gaynor4.

 

NC study examining both POC and PHL use of the SHC.

 

2 NC county HD = WB

NCSLPH = serum

 

562 patients enrolled

 

Gold standard = NCSLPH traditional algorithm (RPR/TS EIA)

Total N = 562

GS = 7 pos  samples

555 neg samples

 

SHC + = 31 (POC)

4.3% discordance

PPV = 22.6%

18 (NCSLPH) 2% discordance

PPV=38.9%

 

96.3% % Agreement b/t POC and NCSLPH

 

Sens = 100% (POC) 100% (NCSLPH)

 

Spec = 95.7% (POC) 98% (NCSLPH)

 

Most robust data set to date. Very good comparison between POC and laboratory setting for the SHC and examines discrepancies b/t the two sites.

 

Data are at this point unpublished, but manuscript going through journal submission.

 

Although a prospective study, there was no discussion about true status of the patients who screened positive. The GS was only considered to be the traditional RPR/TS EIA algorithm, without discussion about clinical follow-up

***Very good discussion about the performance of the SHC. The analysis was a bit confusing, but this may be due to the unpublished manuscript aspect.

 

Once a final manuscript is provided, the article will be easier to read.

Medium