Central Biorepository
Central Biorepository
Facility
The RePORT India Central Biorepository was established in 2016 at the Indian Council of Medical Research-National Institute for Research in Tuberculosis (ICMR-NIRT), Chennai, with support from the Department of Biotechnology, and became fully operational in April 2017.
Goal
The goal of the Central Biorepository (CBR) is to receive, store and disseminate high quality biospecimens with well characterized data to support future research in Tuberculosis (TB).
Process
Clinical research sites across India collect biological specimens from cohorts of active TB patients and their household contacts, process them on-site and ship them to the CBR. The CBR receives and stores these biospecimens at appropriate temperatures following ‘best practices’.
Samples
state of the art facility presently houses more than 25000 samples
Sputum
Mycobacterium tuberculosis isolates
saliva
whole blood for DNA
whole blood for RNA
plasma
quantiferon supernatants
urine
vials of peripheral blood mononuclear cells (PBMC)
Cohort A
Active Pulmonary TB
Mtb isolate subculture for storage
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Whole blood (PAXgene) for storage
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Whole blood (plasma & PBMC) for storage
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Whole blood for storage (genetic analyses)
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Saliva for storage (genetic analyses)
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Urine for storage
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Sputum for storage
Baseline
Visit 1
Visit 2
End of TX (-4/+6 wks)
6 mth Post TX (-4/+6 wks)
TX F/R/W
Cohort B
Household Contacts
Mtb isolate subculture for storage
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Sputum for storage
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Whole blood (PAXgene) for storage
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Whole blood (IGRA) for storage
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Whole blood (genetic analyses) for storage
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Urine for storage
Baseline
Month 4 – 6
Month 12 (+/- 2 mths)
TB Activation Evaluation
Facility
Ultra low deep freezers and Liquid Nitrogen Storage systems for appropriate storage of biospecimen along with a back-up 125 KVA diesel generator for uninterrupted power supply, fire safety alarms and fire extinguishers
7 air-conditioners to maintain appropriate room temperature for efficient operation of the storage systems
Biothermics temperature probes linked with a central server to monitor the temperature of storage equipment 24×7 and send out deviation alerts to the staff
Access control system for restricted access and essential safety equipment like oxygen deficiency monitors
Sample inventory and sample management at the CBR is done through FreezerPRO, a web-based secure software tool for accessing sample details with restricted access
The CBR also has a dedicated sample collection aids/kits storage ware-house for stocking and distribution of specimen collection supplies to the clinical research sites
Peripheral Blood Mononuclear Cell (PBMC)
External Quality Assurance (EQA) Program
The in-country peripheral blood mononuclear cell (PBMC) External Quality Assurance (EQA) Program for RePORT India was established in a project mode to support the Indian labs undertaking sample processing and storage for the RePORT India TB Consortium. With the support and training provided by the team from the Immunology Quality Assurance Program of Duke Human Vaccine Institute, USA, the NIRT PBMC EQA Program was initiated in April 2017. After successful prequalification of the participating sites, quarterly surveys have been implemented since the beginning of 2018. The EQA team also support the training of lab personnel in PBMC isolation and cryopreservation and help sites with troubleshooting and corrective action as and when required.
Team
The Biorepository is manned by an excellent team of lab personnel well trained in Good Clinical Practice (GCP), Good Clinical Practice (GCLP) and International Air Transport Association (IATA) regulations, besides biorepository management (receiving, segregating and storing biospecimens) and online inventory management. The staff strictly adhere to Standardized Operating Procedures specific to each task and apply strict quality control measures in every aspect of Biorepository maintenance. The biorepository team also coordinates between the Clinical Research Sites and Shipping agencies for timely shipment of samples as well as supplies.
Hanna Luke Elizabeth
Ph.D., HOD of HIV/AIDS, ICMR-NIRT
Amsaveni S
M.V.Sc., PGD.Z. CRDF Global
Murugesan S
M.Sc., Technical Officer, Department of HIV/AIDS, ICMR-NIRT
Sathyamurthi P
M.Sc., Technical Officer, Department of HIV/AIDS, ICMR-NIRT
Karthika C
M.Sc., Project Technical Assistant, Department of HIV/AIDS, ICMR-NIRT