Evaluation of the fully automated AIX1000 rapid plasma reagin system compared to a manual plasma reagin testing method for the diagnosis of syphilis

Pyden, Alexander; Kang, Anthony D.; Amato, Sheryl; Dutta, Sachinandan; Berg, Gretchen; Riedel, Stefan

doi:10.1016/j.diagmicrobio.2020.115081

Cited by 4 publications

(5 citation statements)

References 22 publications

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“…Overall qualitative concordances between both methods tested in the retrospective and prospective part of the study were 91.9% and 89.0%, respectively. This is slightly lower than the ≥96.0% concordance found in 2 other studies using different manual RPR kits, making comparison difficult 10,11 …”

Section: Discussionmentioning

confidence: 61%

“…This is slightly lower than the ≥96.0% concordance found in 2 other studies using different manual RPR kits, making comparison difficult. 10,11 Sensitivities and specificities of RPR-A reported by others ranged from 96.4% to 100.0% and from 95.2% to 99.4%, respectively. [10][11][12] We were unable to calculate sensitivity and specificity because samples in the prospective panel were tested for RPR only when TPA was positive.…”

Section: Discussionmentioning

confidence: 85%

“…10,11 Sensitivities and specificities of RPR-A reported by others ranged from 96.4% to 100.0% and from 95.2% to 99.4%, respectively. [10][11][12] We were unable to calculate sensitivity and specificity because samples in the prospective panel were tested for RPR only when TPA was positive. Of note, 28 of 32 discrepancies between the automated and manual RPR assay were explained by a treated syphilis infection still positive in one assay and already negative in the other.…”

Section: Discussionmentioning

confidence: 85%

“…Sensitivities and specificities of RPR-A reported by others ranged from 96.4% to 100.0% and from 95.2% to 99.4%, respectively 10–12 . We were unable to calculate sensitivity and specificity because samples in the prospective panel were tested for RPR only when TPA was positive.…”

Section: Discussionmentioning

confidence: 89%

“…The purpose of this study was to evaluate the analytical performance of AIX1000 in a high-prevalence setting as an alternative method to the manual RPR method using the reversed algorithm. Previous studies [10][11][12] lacked the inclusion of high-titer samples and clinical information and were performed in low-prevalence settings. Overall qualitative concordances between both methods tested in the retrospective and prospective part of the study were 91.9% and 89.0%, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of the AIX1000 Automated Rapid Plasma Reagin Assay in a High-Prevalence Setting

et al. 2023

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Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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Evaluation of the AIX1000 Automated Rapid Plasma Reagin Assay in a High-Prevalence Setting

et al. 2023

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Treponema and Brachyspira

Seña,

Pillay,

Radolf

2023

ClinMicroNow

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Spirochetal phylotypes identified in the human mouth belong exclusively to the genus Treponema . Brachyspira spp. are oxygen‐tolerant anaerobes differentiated by phenotypic growth characteristics and degree of beta‐hemolysis. The epidemiologic importance of Treponema denticola and other oral treponemes arises to a great extent from their occurrence as members of the polymicrobial consortium that causes gingivitis and periodontitis. Two Brachyspira species, Brachyspira aalborgi and Brachyspira pilosicoli , have been associated definitively with human intestinal spirochetosis. The method used for direct detection of Treponema pallidum depends upon the stage of disease, the clinical presentation, and the type of specimen obtained. T. pallidum can be detected in lesion exudate by darkfield microscopy or nucleic acid amplification tests. Most infants with congenital syphilis are asymptomatic at birth. Serologic tests play an important role in syphilis diagnosis by supplementing direct detection methods for early syphilitic lesions, for diagnosing latent infection, and confirming suspected tertiary disease.

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Combination of Amoxicillin 3000 mg and Probenecid Versus 1500 mg Amoxicillin Monotherapy for Treating Syphilis in Patients With Human Immunodeficiency Virus: An Open-Label, Randomized, Controlled, Non-Inferiority Trial

Ando

Mizushima

Omata

et al. 2023

Clinical Infectious Diseases

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Background Amoxicillin plus probenecid is an alternative to intramuscular benzathine penicillin G for treating syphilis in the United Kingdom. Low-dose amoxicillin is an alternative treatment option used in Japan. Methods We conducted an open-label, randomized, controlled, non-inferiority trial between August 31, 2018, and February 3, 2022, to compare 1,500 mg low-dose amoxicillin monotherapy with the combination of 3,000 mg amoxicillin and probenecid (non-inferiority margin 10%). Patients with human immunodeficiency virus (HIV) infection and syphilis were eligible. The primary outcome was the cumulative serological cure rate within 12 months post-treatment, measured using the manual rapid plasma reagin card test. Secondary outcomes included safety assessment. Results A total of 112 participants were randomized into two groups. Serological cure rates within 12 months were 90.6% and 94.4% with the low-dose amoxicillin and combination regimens, respectively. Serological cure rates for early syphilis within 12 months were 93.5% and 97.9% with the low-dose amoxicillin and combination regimens, respectively. Non-inferiority of low-dose amoxicillin compared with amoxicillin plus probenecid overall and for early syphilis was not confirmed. No significant side effects were detected. Conclusion This is the first randomized controlled trial to demonstrate a high efficacy of amoxicillin-based regimens for treating syphilis in patients with HIV infection, and the non-inferiority of low-dose amoxicillin compared with amoxicillin plus probenecid was not seen. Therefore, amoxicillin monotherapy could be a good alternative to intramuscular benzathine penicillin G with fewer side effects. However, further studies comparing with benzathine penicillin G in different populations and with larger sample sizes are needed. Clinical trials registration University Hospital Medical Information Network (UMIN000033986)

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Evaluation of the fully automated AIX1000 rapid plasma reagin system compared to a manual plasma reagin testing method for the diagnosis of syphilis

Cited by 4 publications

References 22 publications

Evaluation of the AIX1000 Automated Rapid Plasma Reagin Assay in a High-Prevalence Setting

Evaluation of the AIX1000 Automated Rapid Plasma Reagin Assay in a High-Prevalence Setting

Treponema and Brachyspira

Combination of Amoxicillin 3000 mg and Probenecid Versus 1500 mg Amoxicillin Monotherapy for Treating Syphilis in Patients With Human Immunodeficiency Virus: An Open-Label, Randomized, Controlled, Non-Inferiority Trial

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