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Monoclonal Antibodies for Research and In Vitro Diagnostic Kits in Hemoglobinopathies: Focus on Sickle Cell Disease and Thalassemia

Innovative tools for Hemoglobinopathy detection using RUO and IVD Monoclonal Antibodies

 

Hemoglobin,  blood protein used to transport oxygen, is found basically inside red blood cells (erythrocytes), which gives them their red color.

 

Human hemoglobin consists of four identical chains :

  • two α (alpha) chains
  • two β (beta) chains

Each of these channels is associated with a prosthetic grouping called heme. The name of hemoglobin comes from two words: heme and globin, symbolized by "Hb".

 

The alpha and beta genes of globin are coded respectively on the chromosomes 16 and 11. But like many proteins, chains hemoglobin present various mutations that have the most often no impact clinical. These diseases are autosomal recessive Mendelian transmission, meaning that the disease appears only in children whose both parents are carriers of the anomaly, it is the homozygous form. In the heterozygous form (only one affected parent), the disease is most often silent, remaining transmissible.

 

More than 500 hemoglobin abnormalities have been listed so far.

 

Hemoglobinopathies—including sickle cell disease (SCD) and thalassemia—are inherited blood disorders caused by mutations in the globin genes, affecting the structure or production of hemoglobin. Affecting millions globally, these disorders require accurate, early diagnosis for effective disease management and prevention.

 

At SYnAbs, we specialize in developing high-performance monoclonal antibodies for research use only (RUO) and in vitro diagnostic (IVD) kits designed to detect and discriminate key hemoglobin variants with unmatched specificity and sensitivity.

 

Sickle Cell Disease and the need for accurate diagnostics

 

Sickle cell disease is one of the most prevalent hemoglobinopathies, particularly in sub-Saharan Africa, India, and the Middle East, with over 300,000 affected newborns annually.

 

The disease is marked by:

  • Vaso-occlusive crises and chronic pain

  • Hemolytic anemia

  • Stroke and acute chest syndrome

  • Increased infection risk

 

Early detection, especially in asymptomatic carriers (HbAS), is critical for genetic counseling and newborn screening. Traditional diagnostics like electrophoresis and genetic testing have limitations in speed, sensitivity, and variant discrimination.

 

SYnAbs’ RUO and IVD Monoclonal Antibodies: Redefining Hemoglobin Variant Detection

 

SYnAbs has created a unique panel of monoclonal antibodies for hemoglobinopathy diagnostics, designed specifically for:

  • Research laboratories

  • Lateral flow assays

  • Sandwich ELISA platforms

  • In vitro diagnostic kit manufacturers

Our antibodies feature:

  • High specificity for each hemoglobin variant (HbA, HbS, HbC, HbE, HbA2 & HbF)

  • No cross-reactivity between closely related variants

  • Compatibility with point-of-care testing (POCT) in low-resource settings

  • Batch-to-batch consistency for reliable assay performance

  • Scalable production using hybridoma, CELLine, and bioreactors

Challenges of Sickle cell disease diagnostic

 

Also called hemoglobinosis S, sicklemia or cell anemia falciformes, Sickle cell disease is a hereditary disease, autosomal recessive, which is characterized by an alteration of hemoglobin. The red blood cells of homozygous individuals, HbS / S, do not practically only contain HbS. These molecules have the property of polymerizing when deoxygenated, giving rise to training of fibers that deform the globule and give it an appearance in sickle" or crescent shape. 

 

The diagnosis is currently made:

  • by examining the shape of the red cells,
  • by analyzing hemoglobin by electrophoresis,
  • by genetic testing. 

Nevertheless, analyzing hemoglobin by electrophoresis presents certain limits:

  • It is not always able to detect all hemoglobin variants: some hemoglobin variants may not be separated by the standard electrophoresis conditions, making them difficult to detect.
  • It may not be able to distinguish between similar variants: some variants of hemoglobin may migrate at the same position on the gel, making it difficult to distinguish between them.
  • It may not detect low levels of hemoglobin variants: if the level of a specific hemoglobin variant is low, it may not be detected by electrophoresis, leading to false-negative results.
  • It takes time to get results: hemoglobin electrophoresis is typically done in a laboratory and it can take some time to get results, which may delay diagnosis and treatment.
  • It may not be as sensitive as other methods: Other methods such as HPLC or DNA-based methods may be more sensitive in detecting rare or low-level variants.

Regarding genetic testing for sickle cell disease, there are certain limitations :

  • False-negative results: genetic testing may not detect all mutations associated with SCD, particularly rare or unknown variants. This can lead to false-negative results, and further testing may be needed to confirm the diagnosis.
  • False-positive results: genetic testing may also yield false-positive results if an individual carries a genetic variant that is associated with SCD, but does not have the disease.
  • Limited diagnostic sensitivity: genetic testing for SCD may not detect all mutations, and it is not always possible to confirm a diagnosis based on genetic testing alone.
  • Cost and accessibility: genetic testing can be expensive and not all patients have access to genetic testing, particularly in low-income countries, with some geographical areas difficult to access and children not registered with the authorities.

Finally, examining red blood cell shape is a simple key diagnostic tool for sickle cell disease (SCD), as it allows identification of the characteristic sickle-shaped RBCs. However, there are certain limitations to this method:

  • Subjectivity: The assessment of RBC shape is often subjective and can be influenced by the skill and experience of the individual performing the analysis.
  • Variability: RBC shape can vary depending on the stage of the disease, making it difficult to accurately diagnose SCD in some cases.
  • Limited sensitivity: The examination of RBC shape may not detect all cases of SCD, particularly milder forms of the disease.
  • False-positive results: The examination of RBC shape may also yield false-positive results if an individual has RBCs that are abnormally shaped for reasons other than SCD.
  • It is not a quantitative measurement: It doesn't give a percentage of how many cells are sickled and it doesn't give information of the severity of the disease.

Anti-Hemoglobin A rat monoclonal antibodies : LO-HbA

 

Detect normal hemoglobin A without cross-reacting with HbS, ideal for distinguishing carriers from sickle cell disease patients.

 

Anti-Hemoglobin Beta S rat monoclonal antibodies: LO-HbS

 

Target the Val6Glu mutation specific to sickle hemoglobin with high precision—perfect for Sickle Cell Disease (SCD) detection.

 

Anti-Hemoglobin C mouse monoclonal antibodies : MA-HbC

 

Designed to recognize the Glu6Lys mutation of HbC, frequently found in West African populations.

 

Anti-Hemoglobin E rat monoclonal antibodies : LO-HbE

 

Detect Glu26Lys mutation in HbE, common in Southeast Asia; essential for diagnosing HbE-beta thalassemia.

 

Anti-pAN-Hemoglobin

 

Broad detection for all hemoglobin types—ideal for sandwich ELISA capture or lateral flow screening. 

 

RUO and IVD Monoclonal Antibodies for Thalassemia Diagnostics

 

Thalassemia is caused by reduced or absent synthesis of alpha or beta globin chains.

 

Beta-Thalassemia

  • Cooley's anemia (β-thal major): severe form needing regular transfusions

  • Intermediate and minor forms: milder symptoms or silent carriers

 

Alpha-Thalassemia

Prevalent in Southeast Asia and parts of Africa, caused by mutations on chromosome 16.

SYnAbs is developing monoclonal antibodies for thalassemia-specific hemoglobin profiles, supporting both qualitative and quantitative hemoglobin variant identification for research applications and IVD kit development.

 

Advantages of SYnAbs Monoclonal Antibodies in Hemoglobinopathy Detection

  • 🧪 Research Use Only (RUO) and IVD-grade monoclonals

  • Rapid and reliable diagnostics—ideal for resource-limited settings

  • 🧬 Target-specific binding to hemoglobin mutations

  • 💡 Versatile assay compatibility: ELISA, lateral flow, western blot

  • 📦 Scalable production to support global diagnostic development up to 150gr/year

Anti-Hemoglobin A2 (HbA2) Mouse Monoclonal Antibodies – MA-HbA2


Specifically developed to detect hemoglobin A2, composed of two alpha and two delta chains (α2δ2), LO-HbA2 enables precise quantification of HbA2 levels—critical in the diagnosis of beta-thalassemia minor and other hemoglobinopathies. No cross-reactivity with HbA, HbF, or HbS ensures high assay specificity.

 

Anti-Fetal Hemoglobin (HbF) Mouse Monoclonal Antibodies – MA-HbF

 

Targeting hemoglobin F (α2γ2), predominantly found in fetuses and newborns, MA-HbF allows sensitive detection of elevated HbF levels often seen in hereditary persistence of fetal hemoglobin (HPFH), beta-thalassemia, and sickle cell disease. Ideal for neonatal screening and hemoglobin switching studies.

 

Whether you're developing IVD kits for sickle cell screening, research tools for thalassemia, or POCT assays for hemoglobin variants, SYnAbs delivers premium monoclonal antibodies for hemoglobinopathies—with proven expertise in overcoming immunogenicity barriers and generating variant-specific antibodies.