TY - JOUR
T1 - The early detection of type 1 diabetes mellitus and latent autoimmune diabetes in adults (LADA) through rapid test reverse-flow immunochromatography for glutamic acid decarboxylase 65 kDa (GAD65)
AU - Aulanni'am, Aulanni'am
AU - Wuragil, Dyah Kinasih
AU - Susanto, Hendra
AU - Herawati, Anita
AU - Nugroho, Yulianto Muji
AU - Laili Fajri, Wahyu Nur
AU - Putri, Perdana Finawati
AU - Susiati, Susiati
AU - Trijoyo Purnomo, Jerry Dwi
AU - Taufiq, Ahmad
AU - Soeatmadji, Djoko Wahono
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2022/1
Y1 - 2022/1
N2 - Background: Diabetes mellitus (DM) is a chronic and costly disease that has become a primary concern worldwide. Type 1 diabetes mellitus is categorized as an autoimmune disease, which results in islet cell apoptosis and insulin-dependent. GAD65 is known as a potential marker of impaired pancreatic β cell function that appears in the initial phase of type 1 DM and latent autoimmune diabetes in adults (LADA). This study aimed to develop a novel rapid test of anti-GAD65 autoantibodies in human serum samples. Methods: We have developed a rapid test for anti-GAD65 autoantibodies in this assay based on the reverse-flow immunochromatography method. Human recombinant-protein antigen for GAD65 was attached as the control line over the nitrocellulose membrane. On the other side, the goat anti-mouse immunoglobulin G (IgG) was coated on the same membrane as a control line. The positive result for GAD65 was confirmed by a colloidal gold signal on the strip. Our novel assay analyzed 276 healthy subjects and 51 type 1 diabetes individuals serum samples from several ethnicities in Indonesia for this study. Results: Among the 276 healthy samples, 225 samples were identified as positive for anti-GAD65 autoantibodies, while 51 samples were negative. Interestingly, the positive results for anti-GAD65 autoantibodies were linear to the decreasing of high-density lipoprotein (HDL) levels and inversely associated with triglyceride levels. A significant correlation with age was observed in all groups. The sensitivity and specificity test proved that this kit has higher accuracy (AUC value = 0.960). Conclusion: The significant advantages of our rapid test for anti-GAD65 autoantibodies provide higher sensitivity, specificity, and stability compared to previous commercial kits. Therefore, it could be proposed as the future clinical diagnostic kit for patient management of type 1 DM.
AB - Background: Diabetes mellitus (DM) is a chronic and costly disease that has become a primary concern worldwide. Type 1 diabetes mellitus is categorized as an autoimmune disease, which results in islet cell apoptosis and insulin-dependent. GAD65 is known as a potential marker of impaired pancreatic β cell function that appears in the initial phase of type 1 DM and latent autoimmune diabetes in adults (LADA). This study aimed to develop a novel rapid test of anti-GAD65 autoantibodies in human serum samples. Methods: We have developed a rapid test for anti-GAD65 autoantibodies in this assay based on the reverse-flow immunochromatography method. Human recombinant-protein antigen for GAD65 was attached as the control line over the nitrocellulose membrane. On the other side, the goat anti-mouse immunoglobulin G (IgG) was coated on the same membrane as a control line. The positive result for GAD65 was confirmed by a colloidal gold signal on the strip. Our novel assay analyzed 276 healthy subjects and 51 type 1 diabetes individuals serum samples from several ethnicities in Indonesia for this study. Results: Among the 276 healthy samples, 225 samples were identified as positive for anti-GAD65 autoantibodies, while 51 samples were negative. Interestingly, the positive results for anti-GAD65 autoantibodies were linear to the decreasing of high-density lipoprotein (HDL) levels and inversely associated with triglyceride levels. A significant correlation with age was observed in all groups. The sensitivity and specificity test proved that this kit has higher accuracy (AUC value = 0.960). Conclusion: The significant advantages of our rapid test for anti-GAD65 autoantibodies provide higher sensitivity, specificity, and stability compared to previous commercial kits. Therefore, it could be proposed as the future clinical diagnostic kit for patient management of type 1 DM.
KW - Autoimmune
KW - Glutamic acid decarboxylase 65 (GAD)
KW - Rapid test
KW - Type 1 diabetes mellitus
UR - http://www.scopus.com/inward/record.url?scp=85122326678&partnerID=8YFLogxK
U2 - 10.1016/j.heliyon.2021.e08695
DO - 10.1016/j.heliyon.2021.e08695
M3 - Article
AN - SCOPUS:85122326678
SN - 2405-8440
VL - 8
JO - Heliyon
JF - Heliyon
IS - 1
M1 - e08695
ER -
