Sickle Cell Disease

Sickle Cell Disease, an inherited blood disorder, 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 Sickle Cell Disease. Additionally, RBCs containing mostly hemoglobin S live only about 16 days compared to 120 days for normal red blood cells. Early diagnosis of sickle cell disease can help start life-saving therapies.

Normal Red Blood Cell

Sickle Red Blood Cell

Sickle red blood cells causing blockage in blood vessels

The Need

Currently, there are no rapid POC tests for sickle cell disease. Diagnosis is made using complex central lab equipment (HPLC and IEF) which have been incompatible for low-resource regions due to bulk size, lack of mobility, cost, difficulties in recruiting trained personnel and unreliable electricity supply. These factors have limited current diagnostic capabilities in low-resource regions, especially in remote and rural areas.

 

Sickle SCAN® is a simple but accurate rapid test that will help overcome the existing diagnostic gap in low-resource regions where SCD is responsible for 9% of all under-five infant mortality. The test can also be used preventatively for genetic counseling to reduce the incidence of sickle cell births.

Device for export only, not for sale in the US

About Sickle SCAN®

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 test can be used for:

  • Newborn screening

  • Premarital/preconception genetic counseling

  • Blood donor screening

  • General screening

 

TEST PRINCIPLE

 

Sickle SCAN® is a rapid, qualitative lateral flow immunoassay kit for the identification of sickle cell disorder of hemoglobins A, S, and C.  A small amount of blood, five microliters, is taken by fingerprick, heelstick, or venipuncture using the provided Capillary Sampler.  The Sampler is placed into the buffered loaded PreTreatment Module to release hemoglobin by lysing erthyrocytes.  Three drops of the treated sample are dropped from the PreTreatment Module and added to the sample inlet of the Sickle SCAN® cartridge.  Results are can be read within five minutes.   The presence of hemoglobin variants A, S, and C will be indicated by blue lines in their designated regions.  

Rapid and Easy Testing

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

  • Does not need supporting equipment or rigorous training

  • Drastically reduces patient waiting time and discomfort

 

IMPORTANT SAFETY INFORMATION

 

  • Not for sale in the United States.

  • Only for in vitro diagnostic use.

  • Performance of Sickle SCAN® may not be suitable for testing of newborns less than 24 hours of age without confirmatory testing on a later date.

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

  • Do not use Sickle SCAN® after expiration date.

  • Do not disassemble Sickle SCAN® kit components, which contain reagents that may be biohazardous, allergenic, and or toxic.

BioMedomics, Inc.

1100 Perimeter Park Drive

Suite 104

Morrisville, NC 27560

USA

For more information:

sales@biomedomics.com

www.biomedomics.com

Tel: 919.890.3070

Email: info@biomedomics.com

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