Can a rapid test diagnose sickle cell at the bedside?
Sickle SCAN, a point-of-care immunoassay, was validated against laboratory gold standards for detecting hemoglobin S and related genotypes.
Source
Validation of a novel point of care testing device for sickle cell disease
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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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.
What they did
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.
What they found
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.
The limits
What it doesn't show
Validation accuracy figures depend on the tested sample mix and lab settings; field performance in low-resource newborn screening programs needs separate evaluation.
Key terms
- Point-of-care test
- A diagnostic performed near the patient with rapid turnaround rather than a central laboratory batch run.
- Sickle cell disease
- Inherited hemoglobinopathy causing hemolysis and vaso-occlusion, most often from HbSS or compound heterozygous genotypes.
- HbS
- Sickle hemoglobin produced by a mutation in the beta-globin gene.
- Limit of detection
- Lowest proportion of a hemoglobin type the assay can reliably indicate.
- HPLC
- High-performance liquid chromatography used as a laboratory standard for hemoglobin fraction quantification.
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Sickle SCAN was validated primarily as a:
Common questions
What was the reference standard?
Institutional hemoglobin electrophoresis or HPLC results treated as gold standard.
How many samples were compared?
137 patient samples measured in duplicate on Sickle SCAN.
Why set a higher LoD for HbA?
To help distinguish genotypes such as HbSβ+ from sickle trait (HbAS).
Did common drugs wreck the test?
No interference was seen for tested levels of penicillin, hydroxyurea, bilirubin, protein, and cholesterol.
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