Diagnostic accuracy
Can a rapid test diagnose sickle cell at the bedside?
Open access · cc by · source: Europe PMC
Sickle SCAN, a point-of-care immunoassay, was validated against laboratory gold standards for detecting hemoglobin S and related genotypes.
How this study connects
Role on claims
Each row is a claim on a concept or method page where this paper supports, challenges, or qualifies the statement. Roles are hand-checked — not a model guess.
A multiplex assay can identify Staphylococcus from blood cultures with very high accuracy.
A multiplex molecular assay on monomicrobial blood cultures identified Staphylococcus at genus level with sensitivity about 99.4% and specificity about 99.7% in a large evaluated set.
Scope note — different target — sickle-cell bedside detection, not blood-culture ID
Limits the claim's scope: a different population, assay, or outcome.
Other tools (sickle cell, pain subtype, frailty trajectories) answer their own accuracy questions.
Other validated tools in this set include a point-of-care sickle-cell device detecting HbS/HbC at low percentages suitable for neonates, StEP pinprick signs highly sensitive/specific for neuropathic vs non-neuropathic pain in specialist clinics, and rapidly rising electronic frailty index trajectories associated with doubled 12-month mortality versus stable frailty.
Evidence for the claim as stated.
History
When this study was placed
Dated entries from the concept change log — when this paper was added or removed as support, challenge, or qualifier on a claim.
Placed as a scope qualifier on Diagnostic Accuracy
A multiplex molecular assay on monomicrobial blood cultures identified Staphylococcus at genus level with sensitivity about 99.4% and specificity about 99.7% in a large evaluated set.
Placed as supporting evidence on Diagnostic Accuracy
Other validated tools in this set include a point-of-care sickle-cell device detecting HbS/HbC at low percentages suitable for neonates, StEP pinprick signs highly sensitive/specific for neuropathic vs non-neuropathic pain in specialist clinics, and rapidly rising electronic frailty index trajectories associated with doubled 12-month mortality versus stable frailty.
Study at a glance
- Design
- Other — Lateral-flow Sickle SCAN vs gold-standard diagnosis on duplicate patient samples
- N
- N=137 · Patient samples measured in duplicate
- Population
- Clinical samples submitted for sickle-cell diagnosis
- Outcome
- Agreement of a point-of-care sickle-cell test with the laboratory gold standard
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Inspect source passages
Can a rapid test diagnose sickle cell at the bedside?
These passages occur verbatim in the stored paper text. They support the points listed below; they do not verify every statement in the explanation.
What device was validated?
The goal of this study was to test the diagnostic accuracy, including the sensitivity, specificity, and limit of detection (LoD) of this novel testing device (Sickle SCAN™) in the laboratory, and confirm the feasibility and validity of the test when used at the bedside.
Against what standards was accuracy judged?
Sickle SCAN™ was compared to either hemoglobin electrophoresis (HYDRASYS acid assay, Sebia, Norcross, GA, USA) or high performance liquid chromatography (HPLC) for each sample using standard guidelines.
Key findings
The device could detect HbS and HbC at low percentages suitable for neonates, showed no interference from tested substances at stated concentrations, and was positioned to confirm sickle trait and common SCD genotypes rapidly.
Methodology
Researchers tested 137 patient blood samples in duplicate with Sickle SCAN and compared results to hemoglobin electrophoresis or HPLC, also measuring limits of detection and common interferents.
Limitations
Validation accuracy figures depend on the tested sample mix and lab settings; field performance in low-resource newborn screening programs needs separate evaluation.
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