SAS‚™ Sickle Cell Test
The SAS™ Sickle Cell Test is intended for use as an aid in the qualitative detection of hemoglobin S (Hb-S) in whole blood. An economical test with proven technology. Simple methodology with results within 5 minutes. Room temperature storage, two-year shelf life. CLIA Classification: Non-waived. For professional in vitro diagnostic use only.
Sickle cell disease is an inherited disease which is characterized by the presence of an abnormal hemoglobin (Hb-S). In normal adults, 95% or more of the hemoglobin is present as hemoglobin A (Hb-A). Infants younger than 3 months of age may have low levels of Hb-S which may not be detectable by this methodology. Hemoglobin S can be inherited in the homozygous state (S/S), which results in sickle cell anemia, or in heterozygous state (A/S), which is usually the benign, asymptomatic sickle cell trait. Hemoglobin S can also occur in the presence of other abnormal hemoglobin, i.e. Hb-C (S/C), thalassemia (S-thal), or Hb-D (S/D). These are referred to as the sickle cell variants and can produce symptoms of varying severity.
The SAS™ 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 (HbSS) and sickle cell trait (HbSA). This test is not recommended for use on newborns under 3 months of age. This test is for in vitro diagnostic professional use.
- Detects sickle cell in whole blood
- Results in 5 minutes
- Easy to read
- Fast, easy and reliable
PRODUCT FEATURES AND SPECIFICATIONS:
- Product characteristics: Detects Hemoglobin S in whole blood.
- Sensitivity/Specificity: 99%/ 99%
- Specimen type: Whole blood
- Time to result: 30 minutes
- Shelf life: 18 months
- Storage: Room Temperature 15°-30°C
- CLIA: Moderate
- Instructions: Add 20 ul whole blood to 2 ml of working sickle cell buffer. Read results in 30 minutes.
CPT CODE*: 85660 – RBC Sickle Cell Test
*All CPT codes are supplied for information purposes only and represent no statement; promise or guarantee by CLIAwaivedTM Inc. that these codes will be appropriate or that reimbursement will be made. It is the responsibility of the service provider to confirm the appropriate coding required by their local Medicare carriers, fiscal intermediaries and commercial payors.