Product Watch
Rapid card test kits from Bhat Bio-Tech India (P) Ltd.
Bhat Bio-Tech India (P) Ltd. announced the launch of new Rapid Card Test Kits with the target that these test kits will be game-changing products in the days ahead for screening of bleeding disorders and blood grouping.
Rapid test kits are also known as lateral flow assay works on immunochromatography principle. The rapid test kits are widely accepted since it is simple, easy to perform, room temperature stable, economical, and show results in few minutes.
Bhat Bio-Tech has partnered with ICMR-NIIH Mumbai under technology transfer model for manufacturing of affordable rapid card tests for hemophilia A (FVIII) and Von Willebrand disease (VWD). Recently, these products were licensed by DCCGI (CDSCO). These rapid test kits are room temperature-stable point-of-care tests, which give results within 20 minutes, and do not require sophisticated instruments or infrastructure. It is easy to perform by any healthcare professional at the healthcare units or field level, thus making it more accessible in diagnosing of underdiagnosed patients/menorrhagia cases/post-partum hemorrhage (PPH), gynecological complications with bleeding history, recovery of factors in the transfused hemophilia A patients and for differential diagnosis of hemophilia A and VWD.
If the specimen has hemophilia A (FVIII) antigen or VWD then a colored line appears in the test region of the test device along with the control line, indicating it as a positive test and if no color in the test region and line in the control region indicating it as a negative test.
As per the ICMR statement “Hemophilia A and VWD are the commonest among bleeding disorders. As per the Western data, the incidence of hemophilia A is 1 per 10,000 male births and that of VWD is around 1 percent of the general population.
In India, there is no epidemiological data and with translation of this data with respect to the population, there may roughly be 80,000–100,000 severe hemophilia cases in our country, but the total number registered with Hemophilia Federation India (HFI) is only around 19000.”
Introducing these kits into the market is the need of the hour to detect bleeding disorders at an affordable price, thus making it simpler to reach the masses to help more screening at the field level to detect the disease with ease.
The rapid tests will not cost more than ₹300 per test, and it is more affordable compared to the present available tests that cost between ₹5000 and ₹10,000 a test. With affordable price, these rapid card test kits are poised to be the game changer in diagnosis of hemophilia and VWD, not only in India but in other parts of the world too.
Another product launched by Bhat Bio-Tech is an in-house innovative product to detect an individual’s blood group ABO by a rapid card test in a single strip with a drop of blood, just like any other rapid test kit. This rapid card test is evaluated by NIB and licensed by DCGI (CDSCO). This product is a room temperature-stable product, which is as an alternative product to the traditional blood grouping sera, a liquid and requires cold chain for transportation and storage, due to which there are some challenges in the stability, breakage, etc. But using rapid card for blood group detection will eliminate the cold storage process and increase the stability. This can help reach the product into rural healthcare set-ups without any hurdle. Most of the healthcare professionals now have sufficient knowledge on how to perform a rapid card test, and similarly they too easily can perform the blood group test of an individual without any further additional learning process.
The product is expected to get acceptance in the market in coming days. This product can be used in primary healthcare centers, field blood camps, schools, colleges, hospitals, and clinical laboratories.
