One of the flagship products of the Institut Biosains in collaboration with PT Biofarma Bandung has been launched in 2014. The product is an early detection kit for Type 1 DM patients based on Reverse flow Immunochromatoghraphy: Biosains Rapid Test GAD65 which is an early diagnostic kit for diabetes which is currently ready for mass production and marketing. This product is one of 2 further research projects with PT Biofarma Tbk. which has been started since 1.5 years ago. Prof. Aulanni’am acts as the person in charge and head of the Biofarma-Universitas Brawijaya collaboration project. The diagnostic kit product still requires field testing in addition to optimization of stability in storage and still requires a large number of patient samples. The product is still labeled For Research Only, and is limited used for research/clinical only.
The diagnostic kit product mentioned above has passed laboratory and patient tests in the field with very good sensitivity results (100%) and 91.67% specificity. UB in this case is ready to produce but still requires adequate building or room facilities in accordance with the needs of production laboratory standards Good Laboratory Practice – Good Manufacturing Practice (GLP-GMP). It is very likely that this product will be commercially marketed by Biofarma as an institution that has the license and authority to market similar products. In the near future, there will be further coordination between Biofarma, UB and BinFar (Directorate General of Pharmaceutical and Medical Devices) related to the registration of diagnostic products as medical devices.
Biosains Rapid Test GAD65 is a rapid test to detect Diabetes Mellitus (DM) type 1 and type 1.5. In this kit, detection is made of the presence of GAD65 autoantibody which is an early marker of pancreatic beta cell damage.
This kit is able to detect the onset of autoimmune diabetes so that it can be performed on infants and children who have a family history of DM sufferers. The use of this kit is an initial screening for DM, which aims to improve the management of DM prevention so it is important for families who have a history of DM, so that they do not continue to be DM sufferers.
Diagnosis is made using blood serum as much as 20 microliters and the results have been obtained within 30 minutes. This kit requires no special tools and is therefore easy to implement at a simple medical service level. The GAD65 Bioscience Rapid Test has been shown to have high sensitivity and specificity.
- Prof. Aulanni’am, drh, DES.
- Prof.dr. Djoko Wahono Soeatmadji SpPD-KEMD.
Anggota Peneliti :
1. Prof. Sutiman B. Sumitro DSC. SU, Drs (FMIPA-UB)
2. Prof. Fatchiyah, PhD.Dra, Mkes (FMIPA-UB)
Tim Asisten Riset Lab. Biosains.UB.
Tim manajemen Lab. Biosains UB.