ASI Sickle Cell Test
Sickle Cell is a hereditary disease, occurring mostly in individuals of African, Mediterranean and Caribbean descent for which abnormal hemoglobin (Hb-S) causes red blood cells (erythrocytes) to become sickle-shaped, fragile and nonfunctional, leading to chronic anemia. Kit does not include controls.
Intended Use
The ASI Sickle Cell Test is intended to be used as an aid in the qualitative detection of hemoglobin S (Hb-S) in anticoagulated whole blood. The test does not distinguish between sickle cell disease (HbS/S) and sickle cell trait (HbS/A). This test is not recommended for use on newborns under 3 months of age. These materials are intended to be acquired, possessed and used only by healthcare professionals.
Features
- Turbidity line test based upon modified Nalbandian procedure
- Detects both homozygous (S/S) and heterozygous (A/S) sickle cell
- Contains urea reagent for test confirmation
- Room temperature storage
- Up to 18 month shelf life (from date of manufacture)
- Accurate, easy and economical
Sensitivity & Specificity
- Sensitivity: >99%
- Specificity: >99%
|
Test Kit Size |
Catalog Number |
|
25 Tests |
200025 |
|
100 Tests |
200100 |
CPT Code 85660
510(k)-K960947
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