ArticleMolecular diagnosis & therapy2021
Herpes Simplex Virus-1 and -2 Rapid Detection in Whole Blood.
Article in Molecular diagnosis & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 8 citations in OpenAlex.
- Why are we doing this alone? A collaborative framework for LDT development and validation.Journal of clinical microbiology · 2026Article
- Evaluation of a sample-to-answer real-time PCR assay for enterovirus detection in cerebrospinal fluid.Journal of clinical microbiology · 2025Article
- Rapid diagnosis of herpes simplex virus 1 and 2 bloodstream infections utilizing a sample-to-answer platform.Journal of clinical microbiology · 2024Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDisseminated herpes simplex virus (HSV) infection has high morbidity and mortality, particularly in neonates, and requires rapid diagnosis for proper treatment. Currently, there are no US FDA-approved assays available to perform HSV testing on blood.
objectivesOur goal was to evaluate the analytical sensitivity and clinical performance of an available sample-to-answer real-time polymerase chain reaction (PCR) platform used as a laboratory-developed test (LDT) for the detection of HSV-1 and -2 in whole blood (WB).
methodsA clinical comparison study comparing a real-time PCR reference assay to a LDT based on the DiaSorin Simplexa Direct assay kit was performed. Analytical sensitivity studies comparing WB to the FDA-approved specimen type, cerebrospinal fluid (CSF), were also conducted with contrived quantified HSV-1 and -2 samples in WB and CSF matrix.
resultsIn total, 102 samples were tested using the LDT and reference assay for the clinical correlation study, with 91 negative and 10 positive results for HSV-1 (n = 7) and HSV-2 (n = 3), exhibiting 100% concordance with comparator results. The overall limit of detection (LoD) for HSV-1 and HSV-2 in WB was comparable to that seen in CSF, with the calculated 95% LoD for blood being 1489 ± 16 copies/ml for HSV-1 and 1187 ± 18 copies/ml for HSV-2 and for CSF being 1168 ± 17 copies/ml for HSV-1 and 953 ± 21 copies/ml for HSV-2.
conclusionsThe performance of the LDT for detection of HSV-1 and HSV-2 in WB specimens is adequate for clinical use. The LoD for HSV-1 and HSV-2 is comparable to that in CSF, the FDA-approved specimen type.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.