TOR 3
2015-16
One day “Laboratory Technician Training Program” was initiated in collaboration with Delhi State AIDS Control Society (DSACS).
• 5 training sessions were conducted in 2016, and about 80 lab technicians posted at either blood banks or integrated counselling and testing centres (ICTCs) of DSACS in Delhi were trained. Other 800 lab technicians are also being identified to be trained in near future.
2016-17
Laboratory Technician Training Program:
• Initiated in 2016 with a one-day program.
• Delhi State AIDS Control Society (DSACS) nominated participants from blood banks and integrated counseling and testing centers (ICTCs).
• Conducted 5 trainings in 2016 and 3 in 2017.
• About 160 lab technicians from DSACS in Delhi were trained.
ECHO Program Involvement:
• Dedicated sessions on Viral Hepatitis Laboratory diagnosis integrated into the ECHO program.
• Primary care physicians were trained through ILBS-ECHO e-learning activities.
Apex Viral Hepatitis Laboratory Designation:
• ILBS recognized as the Apex Viral Hepatitis Laboratory in the Country by Indian Council for Medical Research (ICMR).
• Intention to train microbiologists and laboratory technicians.
• 6 Regional, 16 State Level, and 56 Medical College Level labs funded by the Department of Health Research.
• Aim to strengthen these labs in 2018.
2017-18
Laboratory Training and Demonstrations:
• Dedicated lectures and visits to functional laboratories included.
• Demonstrations of various testing methods such as Rapid card tests, EIA, PCRs.
Training for Physicians and Technicians:
• Regular training for laboratory physicians and technicians provided through one-day hands-on programs.
• Over 100 doctors and technicians participated in the wet lab training program where they performed Hepatitis serological assays.
Clinical Virology Training:
• The Department of Clinical Virology organized a PG assembly on “Clinical Virology made easy” under IAMM-DC at Institute of Liver And Biliary Sciences on 16th and 17th August 2018.
• 60 microbiologists from North Indian medical colleges were trained in this program.
Technician Training under Project PRAKASH:
• Added technician training program as part of Project PRAKASH.
• Conducted 2 trainings in October and November of the current year.
Contributions and Involvement:
• WHO CC ILBS contributed to the formulation of National Viral Hepatitis Testing guidelines.
• Actively engaged in training microbiologists nationwide for starting viral hepatitis testing under the National program.
2019-20
Kit Validation at Department of Virology, ILBS:
• Department of Virology at ILBS designated as Nodal center for evaluating In-vitro Diagnostics (IVD) for Hepatitis B, Hepatitis C, HIV 1&2, Dengue, Influenza viruses.
• Designation based on the provisions of Clause (h) paragraph ii, part II of the medical devices rule 2017 by CDSCO, GOI.
• ILBS Virology lab also designated as avalidation site for various COVID-19 diagnostic kits by ICMR.
Delivered Outputs:
• Conducted over 32 performance evaluations of different in-vitro diagnostic kits.
• Initiatives carried out since September 2019 until the present date.
2020-21
Designation and Recognition:
• Department of Virology at ILBS named Nodal Centre for evaluating In-vitro Diagnostics for Hepatitis B, Hepatitis C, HIV 1&2, Dengue, Influenza viruses.
• Based on Clause (h) paragraph ii, part II of medical devices rule 2017 by CDSCO, GOI.
• ILBS Virology lab designated as Kit validation site for various COVID-19 diagnostic kits by ICMR.
• Well-established Institutional policy and SOP in place.
Outputs Delivered:
• Kit Validation Modules established and approved by internal committee.
• Department of Clinical Virology at Institute of Liver and Biliary Sciences validated various kits for viral hepatitis and other infections:
• HBsAg Next Qualitative and HBsAg Next Confirmatory assay (Architect, Abbott Diagnostics).
• HCV core antigen assay (Architect, Abbott Diagnostics).
• HBV DNA on Xpert (GeneXpert, Cepheid).
• HCV RNA on Genedrive assay.
• HCV RNA by direct finger prick on whole blood by GeneXpert, Cepheid.
Publication and Contribution:
• Published studies related to performance evaluation of point-of-care diagnostic molecular tests for Hepatitis B and C in international journals.
2021-22
Kit Validation and Evaluation:
• Kit Validation Modules established and approved by internal committee.
• Department of Clinical Virology at Institute of Liver and Biliary Sciences conducted validation of various diagnostic kits for viral hepatitis and other viral infections.
• Validated kits include:
• HBsAg Next Qualitative and HBsAg Next Confirmatory assay for qualitative HBsAg detection (Architect, Abbott Diagnostics).
• HCV core antigen assay (Architect, Abbott Diagnostics).
• HBV DNA on Xpert (GeneXpert, Cepheid).
• HCV RNA on Genedrive assay.
• HCV RNA by direct finger prick on whole blood using GeneXpert, Cepheid.
External Kit Validation Work:
• ILBS Virology laboratory evaluated additional kits under external kit validation work from September 2021 to August 2022.
• Altona Diagnostics India Pvt. Ltd. – AltoStar® HBV PCR Kit 1.5, AltoStar® HCV RT-PCR Kit 1.5.
• M/S Tata MD Ltd. – TATA MD Check HBV Viral Load PCR Kit, TATA MD Check HCV Viral Load PCR Kit.
• M/S HLSS Manufacturing Pvt Ltd. – Quantiplus HBV Fast RT-PCR Kit (Real-time Quantitative PCR Kit), Quantiplus HCV Fast RT-PCR Kit (Real-time Quantitative PCR Kit).