The diagnostic services have three major areas:
Retrovirus Laboratory:
The retrovirus laboratory handled about 1,14,098 samples in 2008 which includes rapid tests, ELISAs and western blots for HIV-1, HIV-2 & HTLV-I. The laboratory also does HIV viral load tests, CD4 estimations and HIV-1 drug resistance assay.
The laboratory continues to serve as an evaluation laboratory for the Drugs Controller of India for licensing of HIV kits and HIV antibody testing of parenteral formulations marketed in India. As a policy, all reactive or borderline reactive sera in the screening microparticle EIA (4th generation assay) are always retested by a supplemental EIA and as necessary by molecular test at no extra cost to the patients. The service for self-testing for HIV antibodies is maintained by the National AIDS Control Organization (NACO).
The laboratory also serves as a National Reference Laboratory (NRL) for NACO. We are in charge of the EQAS Programme for Kerala and Lakshadweep. As part of this, we conduct workshops/training for laboratory technicians in these regions. We are testing CD4 estimation for the samples received from the Govt. Medical College & Hospital, Vellore, NACO funded ART Centre, CMC, ART Centre-District Headquarters Hospital, Tiruvannamalai, also, perform HIV Surveillance testing conducted by NACO.
The retrovirus laboratory in the Department of Clinical Virology also participates in the HIV physician training fellowship programme, NACO physicians training programme at FHI-AVAHAN Project Training Workshop. We also conduct an HIV technician training programme coordinated by the Department of Medicine Unit 1 and Infectious Diseases, CMC Vellore.
Hepatitis Laboratory:
This laboratory processed over 1,83,025 samples in 2008.
The laboratory handles an enormous load and a variety of hepatitis virus markers testing. This area of the department has been automated to the extent possible in keeping with international standards. The laboratory is serving as an evaluation laboratory for the Drugs Controller of India for licensing of HBsAg and HCV antibody detection kits and HBsAg and HCV testing of parenteral formulations in India. For those samples that were positive by serology Nucleic acid testing (NAT) was offered. Rapid antibody screening for HCV antibody is used by the Nephrology department regularly for patients coming in for haemodialysis.
This section offers significant support to the Liver Clinic and Liver Transplant Programme by offering HBV and HCV quantitation and HCV genotyping. It is hoped that drug resistance monitoring will become available soon.
Cell Culture Laboratory:
This laboratory processes about 1528 samples per year. It offers a wide range of culture and antibody detection assays inclusive of virus neutralization and indirect immunofluorescence assays. A variety of viral agents (including opportunistic & neurotropic viruses) are also detected by molecular methods. This laboratory has the versatility to perform antibody testing against viruses for which commercial kits are not available. Moreover, students are trained in basic virological skills here. This type of cell culture-based facility is not widely available in many medical laboratories in the country. We provide dengue positive/negative statistics to the Entomologists, Vellore through the Medical Superintendent regularly.
Quality Control and Assurance Programme:
We are in the process of upgrading our quality towards this. We have obtained quality control samples for various viral infectious markers from Bio-Rad Laboratories to carry out EQAS. We are also in the process of achieving NABL accreditation. Towards this, we have prepared a quality manual (with the help of two Pfizer fellows –Mr. Mark Tibbetts & Mr. Roy Gomez), standard operating procedures (SOPs) for all the assays & calibration of all the instruments. Dr. Rajesh Kannangai, Professor in this department is the quality manager. We also perform inter-laboratory comparisons of our results with St. Johns Medical College & Hospital, Bangalore and YRG Care, Chennai. We test HIV, HBsAg and HCV antibody serum samples received periodically from the Central Drugs Control Standard Organization, Drugs Controller of India (Chennai). 155 blood products were received and tested in 2008. As part of the Integrated Disease Surveillance Programme, the laboratory will be reporting on several viral infections. We perform quality control testing to the SLR&TC Karigiri, Clinical Biochemistry and Clinical Pathology & Blood Bank departments.
