Enssure Sickle Cell Rapid Test Kit

Sickle Cell

Testing Procedure

Intended Use

The Sickle Cell Rapid test kit is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, C and S using fingerstick or venipuncture whole blood samples.

Principle

The Sickle Cell Rapid test kit is a qualitative lateral flow immunoassay for identifying hemoglobins A, C, and S in sickle cell disorder. A fingerstick or venipuncture collects 10 µL of blood, which is added to a pre-filled extraction tube. The lysed sample is then applied to the Sickle Cell card test. After 10 minutes, the sample interacts with colorimetric detector nanoparticles and travels to capture zones. Four detection lines are possible, including a control line, indicating proper test flow. Red lines in specific regions reveal the presence of hemoglobin variants A, C, and S.

Importance to know

Warnings and Precautions

•  Please read the instruction carefully before performing the test.

• Do not use the test after the expiration date.

• Immediately carry out the test after removing the test device from the pouch.

• Do not mix or interchange the specimen sample.

Limitation

• Performance of Sickle Cell has not been established for sickle cell patients with beta-thalassemia.