A process for the preparation of diagnostic kit for the detection of β-thalassemia syndromes

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Technology Description

 

A diagnostic kit for the detection of B-thalassemia syndromes has been developed by NIIH Mumbai. The kit uses the principle of PCR and reverse dot blot hybridization for detection of common Indian β-Thalassemia Syndromes. The inherited hemoglobin disorders are the commonest single gene disorders in India causing considerable morbidity and mortality. Identification of the mutations causing b-thalassemia major, sickle cell anemia, Hb S-b thalassemia and Hb E – b-thalassemia are very important for control of these disorders by prenatal diagnosis. The methods is based on allele specific priming screen for each mutation individually. The kit for Reverse Dot Blot Hybridization can screen for 6 common Indian b-thalassemia mutations and the 2 common abnormal hemolgobins Hb S and Hb E in a single PCR and hybridization step. The kit provides an easy and economical method for detection of six common Indian β-Thalassemia mutations along with two abnormal heamoglobins, HbS and HbE in a single PCR and hybridization step with great accuracy, without using radioactive isotopes and hazardous reagents. In the market one kit from international company is available which is covering 8 alterations ( as compared to nine alterations in our kit) and the cost is about 4000- 5000 Rs per sample. One Indian company has introduced the kit which is covering only five alterations and which covers about 40- 50% of Indian thalassemic alleles.

 

Institution: NITM

 

Category : Diagnostic

 

Cost effective : YES-kit is the best one covering more than 90% of the thalassemic alleles and the cost per sample is about 1700-2000Rs.

 

In vivo studies : No information

 

Life of Patent : upto 2021 (4 years left)

 

Validation : under process

 

Prototype : Yes- Bench scale/ Imgenex is manufacturing 51 kits

 

Public health relevance : YES-Can be used for rolling out National Program on Beta -thalasemia

 

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