Sickle SCAN

BioMedomics™ Sickle SCAN® is a multiplexed, qualitative, point-of-care immunoassay to aid in 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 disease samples.

Sickle cell disease (SCD) is an inherited blood disorder which often causes red blood cells (RBCs) to become sickle-shaped through the presence of the abnormal hemoglobin S variant. Highly 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 SCD. Additionally, RBCs containing mostly hemoglobin S live only about 16 days compared to 120 days for normal red blood cells. To initiate life-saving therapies, early diagnosis of SCD is key.

Before Sickle SCAN, SCD diagnosis was only possible using complex lab equipment. In low-resource regions where SCD is responsible for 9% of all under-five infant mortality, infrastructure challenges make central lab testing impractical. Sickle SCAN helps overcome the diagnostic gap. Ideal for providing quick and accurate results at the point-of-care, the test requires no supporting equipment and can also be used preventatively for genetic counseling to reduce the incidence of sickle cell births.

Features & Benefits

The test can be completed in under 5 minutes giving real time results. It uses a small amount of whole blood from a fingerstick, heelstick, or venipuncture.

Compared to traditional central lab testing, Sickle SCAN:

  • Eliminates the need to transport samples
  • Streamlines the clinical work flow
  • Requires no supporting equipment or rigorous training
  • Drastically reduces patient waiting time and discomfort

How It Works

Steps

1. Collect a 5 µL blood sample.

2. Mix blood with buffer solution

3. Place 5 drops on test strip and wait 5 minutes.

Results

FAQs

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 2 years, although the test has been used on newborns older than 24 hours successfully for clinical research purposes.

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.

Product Comparison

1Time to Result
Sample Prep
Trait Detection
2Environmental Risk
Predictive Value
Sickle SCAN
5 minutes
No
Yes
Low
>99%
Other Lateral Flow
10 minutes
No
Yes
Med
>99%
Solubility Testing
40 minutes
Yes
No
High
>40%
HPLC
60 minutes to
2+ days
Yes
Yes
High
>99%
Gel Electrophoresis
60 minutes to
2+ days
Yes
Yes
High
>99%

1 The first three tests are all true point-of care tests that do not require transporation of blood samples to a central laboratory. Times for HPLC and Electrophoresis vary widely depending on how long it takes to transport blood samples to the lab and then communicate results back to te patient.

2 Sickle SCAN kits contain all items critical to conducting the test, including buffer solution. Other Lateral Flow tests and Solubility Tests may require the external sourcing of buffer which introduces an important envionmental risk. Both HPLC and Electrophoresis require reliable electrical supply, stric environmental controlos, and sensitive reagents to reliably run tests.

Find Out More

Contact Info

ADDRESS

BioMedomics, Inc. 1100 Perimeter Park Drive Suite 104 Morrisville, NC 27560 USA

CALL US

919.890.3070

E-MAIL

info@biomedomics.com