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MA2039

Sickle Cell Rapid Test

This point-of-care, rapid test kit determines the presence of hemoglobin A, S, and C (can detect hemoglobin phenotypes HbAA, HbSS, HbSC, HbCC, HbAS, and HbAC) and is intended for in vitro diagnostic use by health professionals.

  • Competitive lateral flow immunoassay
  • Can be used with whole blood samples
  • Results ready in 10 minutes

THE PROBLEM

Sickle cell disease (SCD) is an autosomal recessive inherited hemoglobin disease that leads to shortened red blood cell survival and anemia. Over 300,000 babies are born every year with a severe hemoglobin disease, of which SCD is the most common. Those with the disease can suffer from chronic acute pain syndromes, severe bacterial infections, and tissue death. In places where SCD is prevalent, like sub-Saharan Africa, it can be difficult to diagnose SCD because many SCD tests are capital intensive and require laboratory equipment, highly-trained professionals and stable power, which are not easily available in these areas. Without early SCD detection among infants and young children and subsequent monitoring, children with the disease are at an increased risk of preventable SCD-related mortality. In fact, in sub-Saharan Africa anywhere from 50-90% of children with SCD will die due to the disease before their fifth birthday.

THE SOLUTION

This point-of-care sickle cell rapid test is a competitive lateral flow immunoassay and detects the presence of hemoglobin A, S, and C through monoclonal antibodies. These antibodies are blind to Hemoglobin F (a hemoglobin produced in infants) so that even infants can be tested for SCD. Hemoglobin A (HbA) is the normal hemoglobin found in humans. Hemoglobin S (HbS) is the abnormal hemoglobin most commonly found in people with SCD. Hemoglobin C (HbC) is the abnormal hemoglobin found in people with Hemoglobin C disease (rare and mild disease compared to sickle cell disease). 

To test, a sample of whole blood is absorbed by a blood sample device (included in kit) and inserted and swirled in a test vial filled with water (not included) until the water becomes pink or light-red in color. Then, leaving the blood sampling device in the vial, a test strip (included) is inserted into the vial and left for 10 minutes. The results are then ready to be read.

The ready-to-read test strip will display red lines for HbA, HbS, and HbC. The presence of a line at the given location for a particular hemoglobin type indicates the absence of the hemoglobin type. The absence of the line indicates the presence of the type.

If a person only has the line absent for Hemoglobin S or C, they have SCD or Hemoglobin C disease, respectively. If a person has lines absent for both HbA and HbS or HbA and HbC, then they are a carrier for the respective disease and generally will not present symptoms. If a person has lines absent for both HbS and HbC, they have Hemoglobin SC disease, a disease similar but generally less severe than SCD. A person with only the line for HbA absent does not have any disease and is not a carrier.

*Test kit includes 50 blood sampling devices, 50 test strips and 3 reusable dropper pipettes.

This point-of-care, rapid test kit determines the presence of hemoglobin A, S, and C (can detect hemoglobin phenotypes HbAA, HbSS, HbSC, HbCC, HbAS, and HbAC) and is intended for in vitro diagnostic use by health professionals.

  • Competitive lateral flow immunoassay
  • Can be used with whole blood samples
  • Results ready in 10 minutes

THE PROBLEM

Sickle cell disease (SCD) is an autosomal recessive inherited hemoglobin disease that leads to shortened red blood cell survival and anemia. Over 300,000 babies are born every year with a severe hemoglobin disease, of which SCD is the most common. Those with the disease can suffer from chronic acute pain syndromes, severe bacterial infections, and tissue death. In places where SCD is prevalent, like sub-Saharan Africa, it can be difficult to diagnose SCD because many SCD tests are capital intensive and require laboratory equipment, highly-trained professionals and stable power, which are not easily available in these areas. Without early SCD detection among infants and young children and subsequent monitoring, children with the disease are at an increased risk of preventable SCD-related mortality. In fact, in sub-Saharan Africa anywhere from 50-90% of children with SCD will die due to the disease before their fifth birthday.

THE SOLUTION

This point-of-care sickle cell rapid test is a competitive lateral flow immunoassay and detects the presence of hemoglobin A, S, and C through monoclonal antibodies. These antibodies are blind to Hemoglobin F (a hemoglobin produced in infants) so that even infants can be tested for SCD. Hemoglobin A (HbA) is the normal hemoglobin found in humans. Hemoglobin S (HbS) is the abnormal hemoglobin most commonly found in people with SCD. Hemoglobin C (HbC) is the abnormal hemoglobin found in people with Hemoglobin C disease (rare and mild disease compared to sickle cell disease). 

To test, a sample of whole blood is absorbed by a blood sample device (included in kit) and inserted and swirled in a test vial filled with water (not included) until the water becomes pink or light-red in color. Then, leaving the blood sampling device in the vial, a test strip (included) is inserted into the vial and left for 10 minutes. The results are then ready to be read.

The ready-to-read test strip will display red lines for HbA, HbS, and HbC. The presence of a line at the given location for a particular hemoglobin type indicates the absence of the hemoglobin type. The absence of the line indicates the presence of the type.

If a person only has the line absent for Hemoglobin S or C, they have SCD or Hemoglobin C disease, respectively. If a person has lines absent for both HbA and HbS or HbA and HbC, then they are a carrier for the respective disease and generally will not present symptoms. If a person has lines absent for both HbS and HbC, they have Hemoglobin SC disease, a disease similar but generally less severe than SCD. A person with only the line for HbA absent does not have any disease and is not a carrier.

*Test kit includes 50 blood sampling devices, 50 test strips and 3 reusable dropper pipettes.

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