Intended to be used as an aid in the qualitative detection of hemoglobin S in anticoagulated whole blood. The test does not distinguish between sickle cell disease and sickle cell trait.

This test is not recommended for use on newborns under 3 months of age.

• Accurate, easy, and economical test with proven technology
• 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
• 2-year shelf life from date of manufacture

Certifications:

• CPT Code 85660
• 510(k)-K960947

Sensitivity & Specificity:

• Sensitivity: >99%
• Specificity: >99%