BioMedomics Sickle SCAN is a multiplexed, qualitative, point-of-care immunoassay used for the rapid diagnosis of sickle cell disorders. The test is made up of three indicators, which detect the presence of hemoglobins A, S and C, allowing the user to rapidly distinguish between normal, carrier and sickle cell samples.

The BioMedomics Sickle SCAN test kit, which contains:

• Sickle SCAN Cartridge
• Capillary Sampler
• Pre-Treatment Module (containing buffer solution)
• Package Insert

Materials not provided but required:

• Lancet
• Alcohol wipes
• Gloves
• Timer

After the specimen and buffer mixture has been correctly dispensed into the BioMedomics Sickle SCAN cartridge, allow the test to run for 5 minutes.

Specificity and sensitivity of the BioMedomics Sickle SCAN Rapid Test was evaluated by comparison with hemoglobin electrophoresis, one of the standard lab tests for sickle cell diagnosis. Results are shown below:

BioMedomics Sickle SCAN tests for sickle cell trait, sickle cell anemia and HbSC disease.

Sickle Cell Trait: People with one sickle cell gene and one normal gene have sickle cell trait (SCT). SCT patients usually do not exhibit any of the symptoms of sickle cell disease (SCD) but have the potential to pass the trait onto their children. If both parents have SCT, there is a 25% chance their child will be an SCD patient.

Sickle Cell Disease: Sickle Cell Disease (SCD), an inherited blood disorder, often causes red blood cells to become sickle shaped through the presence of the abnormal hemoglobin S variant. The more rigid sickle-shaped blood may have difficulty passing through small blood vessels, blocking the normal blood flow, damaging tissues, and ultimately leading to many of the complications of Sickle Cell Disease.

HbSC Disease: HbSC Disease patients have hemoglobin C and hemoglobin S, which are both abnormal hemoglobins. HbSC disease is a milder sickling disorder, and symptoms are similar to that of SCD’s but are less frequent and less severe.

A total of four detection lines are possible, with the control line appearing when the sample has been flowed through the cartridge. A blue line appearing will indicate the presence of hemoglobin variants A, S, and C greater than the limit of detection. The diagram below demonstrates the expected results of hemoglobin variants that the provider may encounter:

Anyone can inherit the HbS and HbC gene mutations, but is more prevalent among those of African ancestry and those whose heritage traces back to the Mediterranean, South and Central America, the Middle East, India, and the Caribbean.

BioMedomics Sickle SCAN can be used to test any patient older than 24 hours postpartum.

No test preparation is needed. However, testing should not be performed after a recent blood transfusion.

Other tests typically used for the diagnosis of sickle cell disease and trait are: hemoglobin electrophoresis, hemoglobin isoelectric focusing, and hemoglobin fractionation by HPLC. Hemoglobin S solubility testing is sometimes used only for diagnosing sickle cell disease (not trait or non-S variants), but it cannot be used for newborn screening and has very low predictive value. With the exception of solubility testing, all of these tests need to be conducted in a lab setting, and when considering the cost of sample transportation, equipment, and technicians involved, these lab tests can be more costly and time-consuming than point-of-care tests.