Performance of the bioLytical Multiplex HIV 1/2 and Syphilis rapid test on serum in a laboratory evaluation for syphilis
Bibliographic record
Abstract
Syphilis, a sexually transmitted infection, is resurging with large outbreaks worldwide. In pregnant females, vertical transmission can result in stillbirths and serious sequelae for the fetus. Syphilis serology is primarily used to make the diagnosis, but the testing platforms and confirmatory tests are often centralized; therefore, the time to a result is usually more than 2 days. Most affected populations in the current outbreaks can be transient and easily lost to follow up. Therefore, rapid testing can assist with timely detection, treatment, and linkage to care. We evaluated the performance of the INSTI Multiplex HIV-1/2 Syphilis rapid test, using a large panel of negative and confirmed positive sera with varying rapid plasma reagin (RPR) titers. Sera with RPR titers of 1:8 and greater consistently gave a positive rapid test result (93.8%-100%; 95% CI: 82.5%-100%), whereas samples with RPR titers of 1:2 and lower were often negative (7.6%-56.5%). Rapid test positive samples generally had a syphilis CMIA S/CO ratio of 19.78 and higher, although there was no specific ratio that separated all positive from negative rapid results. In infectious syphilis, RPR titers are often 1:8 and greater and should be reliably detected with this rapid test (accuracy 97.2%), thereby supporting immediate treatment and linkage to care with a high level of confidence. Additionally, a result is available within minutes and therefore could be included on acute care STAT laboratory test menus while the individual is an in-patient or awaiting assessment in the Emergency Department. IMPORTANCE: We examined the performance of the syphilis antibody component of a rapid multiplex device and found that sera with RPR titers of 1:8 and greater, often found in infectious syphilis, were highly likely to test positive. This device would be suitable for providing STAT syphilis serology testing for suspect cases waiting in the Emergency Department or as inpatients. Positive results can support immediate treatment and linkage to care, especially for pregnant females and transient persons who are often lost to follow up.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".