HEMOTYPE SC SICKLE CELL SCREENING STRIPS 50TEST

Description

Intended use HemoTypeSCTM is a rapid test kit for the determination of haemoglobin (Hb) type in whole blood Assay principle Competitive lateral flow assay Antibody type Monoclonal Sample preparation Whole blood Sample type EDTA, finger prick. heel stick, dried blood spots Sample volume 1.5ul Storage & stability Unopened: 15-40oC for 2 years Opened: 30 days Type of result Qualitative No Separate Liquid Buffer Required Limit of Detection for Haemoglobins A, S, and C <2%, <2%, & <2%, respectively. Time to result 5-10 minutes No Interference by fetal haemoglobin Suitable for newborn screening Test procedure 2-step procedure No Requirement for an instrument Sensitivity (for all phenotypes) ≥98% in field conditions2,3,4 Specificity ≥98% in field conditions2,3,4 Overall diagnostic accuracy >98% in field conditions3 Internal controls Internal control Pack size 50 tests including 50 blood sampling devices and 3 dropper pipettes