About the Laboratory

YRGCARE Infectious Diseases (ID) Laboratory located at the Voluntary Health Services (VHS) Hospital Campus, Taramani, Chennai-600113, was established in 2000 in collaboration with Johns Hopkins University, Baltimore, USA and Brown University, Rhode Island, USA with a financial grant from the National Institutes of Health (NIH), an agency of the United States Department of Health.

Nobel Laureate “Dr. Françoise Barré-Sinoussi (co-discoverer of HIV)” visiting the YRGCARE Laboratory. Along with her are (left to right) Dr. Sunil Solomon, Dr. Suniti Solomon, and Dr. Saravanan, of YRGCARE.

This ID laboratory is staffed by experienced and qualified professionals and has good infrastructure to meet all the emerging needs of diagnosing HIV and other infectious diseases (such as sexually transmitted infections [STI], tuberculosis [TB] and viral hepatitis) with state-of-the-art equipment in its 8500 square foot facility. The laboratory’s divisions are: Serology; Microbiology & Mycobacteriology; Biochemistry; Hematology & Immunohematology; Immunology & Core Immunology; and Molecular Biology & Genotyping.

The laboratory is engaged primarily in quality assured diagnostic services with the ISO 15189:2012 quality management system, conducting biomedical research in the areas of the basic sciences and offering educational programs organized by qualified scientists/faculty. Laboratory staff have attended several workshops on diagnostic and research methodology; this includes international training programmes.

The major diagnostic laboratory services include:

• HIV/ART monitoring tests (CD4 count and HIV-1 viral load).
• Opportunistic Infections (OIs) including bacterial, fungal, parasitic and TB infections.
• Sexually Transmitted Infections (STIs).
• Viral hepatitis.
• Drug toxicity related tests.
• PCR (Real Time PCR, Multiplex PCR) based molecular tests for HIV-1, HBV, HCV, TB and CT/NG.
• Genotyping by Sanger’s capillary gene sequencing for HIV-1, HBV and HCV.

Laboratory Milestones

2000: Establishment of YRGCARE ID Laboratory at VHS.
2001: Recognized by University of Madras as an affiliated research institution for PhD program (Medical Microbiology).
2003: Introduction of cost-effective CD4 count test.
2004: Introduction of HIV-1 drug resistance test (Genotyping) for patient care services.
2006: NIH (USA) recognized YRG Laboratory as an “International Regional Specialty Genotyping Laboratory (IRSGL)” for HIV-1 drug resistance test.
2008: Organized First International Science Symposium on HIV & Infectious Diseases.
2008: YRG Laboratory was accredited by NABL (Govt. of India) for ISO15189:2012.
2009: YRG Laboratory was recognized by DSIR (Govt. of India) as R&D.
2010: YRG Laboratory organized 1stInternational Workshop on GCLP.
2011: YRG Laboratory was endorsed by CAVD/CAVIMC to perform certified HIV Neutralizing Antibody (NAb) assays.
2012: NIH (USA) recognized YRG Laboratory as an “International Regional TB Diagnostic Laboratory (RTBDL)”.
2013: “Biospecimen Repository Facility” dedicated by Dr.Ramesh Paranjape (Director-NARI).
2014: “HIV Cure Research Laboratory” dedicated by Prof. Françoise Barré-Sinoussi (HIV co-discoverer & Nobel Laureate).
2015: “Polychromic Flowcytometry” dedicated by Dr. Carl Dieffenbach (Chief of Division of AIDS, NIH).
2016: Introduction of Rapid HIV-1 viral load test (results in 3 hours time) with GeneXpert IV system.

Diagnostics

YRGCARE Infectious Diseases Laboratory offers testing services from Monday through Saturday (9.00 AM to 5.00 PM) and on Sunday (between 10.00 AM – 4.00 PM). These services are quality assured and offered in a cost effective manner, with a rapid turnaround time. Apart from the HIV/AIDS and Sexually Transmitted Infections (STIs) related tests, the laboratory also offers comprehensive master health-checkup packages to evaluate the general health status. We also have arrangements in place, to test the samples referred from clinics/hospitals in various parts of the country, for both routine testing and master health-check ups.

HIV – SPECIAL TEST PACKAGES:

1. ART Monitoring Package I:

This package includes all key lab tests (hemoglobin, platelet, total lymphocyte count, CD4 count, CD4%, bilirubin and ALT) that are commonly used to assess the health of HIV patients with or without antiretroviral therapy (ART). The CD4 count and CD4% results are derived from standard flowcytometer.

2. ART Monitoring Package II:

This package includes all key lab tests (hemoglobin, platelet, total lymphocyte count, CD4 count, CD8 count, CD4%, CD8%, bilirubin and ALT) that are commonly used for the health assessment of the HIV patients with or without ART. The CD4 count and CD8 count results are derived from standard compact flowcytometry equipment.

For the ART Monitoring Package I and II, the specific sample requirements, testing methodology details, standard turnaround time for the test report and pricing can be downloaded here.

SEROLOGY:

Serological tests detect either antibody or antigen of the infecting organism (viral, bacterial, fungal and parasitic). Results from rapid tests are available in a few hours. These tests are conducted using either serum or EDTA plasma as samples. The HIV antibody testing is done based on the testing algorithm of the National AIDS Control Organization (NACO), Government of India, New Delhi with the pre- and post-test counseling.

The specific sample requirements, testing methodology details, standard turnaround time for the test report and price details can be downloaded here.

1. HIV Antibody Test, HIV 1&2 (RAPID)
2. HIV-1 Western Blot
3. HBsAg ELISA
4. Anti-HCV ELISA
5. Toxoplasma IgM & IgG Ab (RAPID)
6. Cryptococcus Ag (RAPID)
7. RPR (VDRL)
8. RPR (VDRL) with TITRE
9. TPHA
10. Widal Test
11. Serum Toxoplasma IgM Ab (RAPID)

HEMATOLOGY & IMMUNO-HEMATOLOGY:

In HIV patients, hematological tests 1-9 on the list below are used to assess ART drug-associated toxicities and the immune-hematological tests (10 & 11) are used to assess the body immune level (HIV disease status) of the patient. The tests are performed with EDTA whole blood and results are usually available in a few hours.

The specific sample requirements, testing methodology details, standard turnaround time for the test report and price details can be downloaded

1. Complete Blood Count (CBC), excluding ESR
2. Hemoglobin (Hb)
3. Erythrocyte Sedimentation Rate (ESR)
4. WBC Differential Count
5. Blood Grouping / Typing
6. BT & CT
7. Reticulocyte Count
8. Eosinophil Count
9. Peripheral Blood smear
10. CD4 / CD8 Count (BD-FACSCount)
11. CD4 Absolute Count & CD4% (Coulter PLG)

MICROBIOLOGY & MYCOBACTERIOLOGY:

HIV-infected patients are susceptible to opportunistic infections (OIs) caused by a variety of microbes; a common infection is tuberculosis. To test for such infections, some samples such as urine or sputum are self-collected by patients based on guidelines that we provide.
The Tuberculosis (TB) PCR (GeneXpert MTB/RIF Assay) is a rapid PCR test and the result is given within 3 hours time.

The specific sample requirements, testing methodology details, standard turnaround time for reports of the various tests and price details can be downloaded

1. Gram Staining
2. AFB Staining
3. Staining for Cryptosporidium
4. Negative Staining for Cryptococcus
5. Wet Mount (KOH) for Fungus
6. Wet Mount for Parasites
7. Bacterial Culture & Sensitivity (samples include: sputum, urine, stool, pus, CSF, throat swab, urethral swab, vaginal swab, pleural fluid, ascetic fluid, FNAC and skin scrapings)
8. Blood Culture & Sensitivity
9. Culture for Fungus
10. AFB (TB) Culture
11. AFB (TB) Drug Sensitivity
12. Tuberculosis (TB) PCR (GeneXpert MTB/RIF Assay)

MOLECULAR BIOLOGY & GENOTYPING:

Various molecular biological and genotyping tests (assays) monitor infection by HIV and the Hepatitis B and C viruses, assess how effective treatment is, and help in the decision to switch drugs or treatment regimens. The Multiplex CT/NG PCR is used to diagnose the infections by Chlamydia trachomatis and Neisseria gonorrhoeae.

The specific sample requirements, testing methodology details, standard turnaround time for the test report and price details can be downloaded

1. HIV-1 Plasma Viral Load (ABBOTT Real-Time PCR)
2. HIV-1 Drug Resistance Test/Genotyping (gene sequencing) – RT Drugs
3. HIV-1 Drug Resistance Test/Genotyping (gene sequencing) – PI Drugs
4. HCV Plasma Viral Load (ABBOTT Real-Time PCR)
5. HCV Genotyping Test (gene sequencing)
6. HBV Plasma Viral Load (ABBOTT Real-Time PCR)
7. HBV Genotyping (gene sequencing)
8. CT/NG Multiplex PCR (ABBOTT Real-Time PCR)

CLINICAL PATHOLOGY

Our laboratory performs various tests pertaining to clinical pathology as needed in individual cases. The specific sample requirements, testing methodology details, standard turnaround time for the test report and price details can be downloaded

1. Complete urinalysis
2. Stool analysis – (Occult blood & Wet mount for parasites)
3. Cerebrospinal fluid analysis
4. Pregnancy test (rapid)
5. Ascitic fluid analysis
6. Pap smear (conventional & liquid-based cytology)

CLINICAL BIOCHEMISTRY

Our laboratory performs various tests pertaining to clinical biochemistry as needed in individual cases.The specific sample requirements, testing methodology details, standard turnaround time for the test report and price details can be downloaded

1. Blood Glucose (Random, Fasting, Post-Prandial)
2. Glucose Tolerance Test (GTT)
3. Renal Function Test- (RFT) -Blood Urea & Creatinine
4. Liver Function Test (LFT)
5. Bilirubin (Total, Direct & Indirect), SGOT (AST), SGPT (ALT), Gamma GT, Alkaline phosphatase, Total Protein, Albumin
6. Lipid Profile-(LDL Measured)-(Cholesterol, TGL, HDL, LDL & VLDL)
7. Lipid Profile-(LDL Calculated)-(Cholesterol, TGL, HDL, LDL & VLDL)
8. Cardiac Profile – (CPK, CK-MB, LDH & SGOT)
9. CPK
10. LDH
11. Serum Electrolytes (Na+,K+,HC03- & Cl-)
12. Uric acid
13. Calcium
14. Phosphorous
15. Serum Amylase
16. Serum Lipase
17. Lactate
18. Insulin
19. Protein Profile – (Total Protein, Albumin, A/G Ratio)
20. US C-Reactive Protein (US-CRP)
21. CK-MB
22. CRP
23. ASO
24. HbA1C
25. RF

Education

Doctoral Degree Programme in Medical Microbiology

YRGCARE Infectious Diseases Laboratory is affiliated to the University of Madras to conduct a PhD degree programme in Medical Microbiology. The program commenced from 2001.

Applications for the PhD degree course in Medical Microbiology are invited from candidates who have passed national entrance tests for independent fellowships such as CSIR/ DBT / INSPIRE fellowship. For more details, please write to lab@yrgcare.org

Graduates of the PhD program thus far are:

PG Diploma in Infectious Diseases

YRGCARE Infectious Diseases Laboratory has offered a PG Diploma course in Infectious Diseases from 2010.

Applications for the PG Diploma (Infectious Diseases) course are invited from candidates who hold the BSc or MSc (Microbiology) degree. For more details, please write to lab@yrgcare.org

Previous batch of candidates awarded with the PG Diploma (Infectious Diseases) with Prof. Suniti Solomon:

Anitha Ramaswamy, Dr. Suniti Solomon, Badrinath, M. Selvakumar

HIV Test Counseling (HTC) Training:

YRGCARE Infectious Diseases Laboratory along with YRGCARE Training Team conducts two day training course on Pre- and Post-HIV Test Counseling (HTC) each quarter. The training course is based on the National AIDS Control Organization (NACO) guidelines to ensure uniformity in counseling and testing services across the country The National Accreditation Board of Laboratories (NABL) requires laboratory staff to be trained and certified for providing Voluntary Counseling and Testing (VCT) services.

For more details on the future programmes, please write to us at VCTtraining@yrgcare.org

Research

The key broader areas of the basic science research activities at the YRGCARE Infectious Diseases Laboratory include:

• Diagnostics: Performance evaluation of newer and cost-effective diagnostic and low-tech assays for diagnosis of infectious diseases (HIV, Sexually Transmitted Infections, Tuberculosis, Hepatitis viruses and opportunistic infections [OIs]).
• HIV Immunology: Humoral and Cell-Mediated Immunity in exposed sero-negative women, long term non-progressors (LTNPs) and elite controllers (ECs). Immune activation in virologically suppressed patients.
• HIV Virology: Understanding HIV-1 drug resistance and drug resistance in genital compartment.
• HIV Cure research: Measure & characterize HIV-1 viral reservoirs that cause rebounding of viral level.
• Hepatitis Viruses: Molecular characterization of hepatitis viruses and its evolution.
• Tuberculosis: Newer biomarkers in early diagnosis of TB associated disease.
• Pharmacology: Measuring HIV drugs in blood and genital compartment.

Quality Accreditation

The YRGCARE Infectious Diseases Laboratory has adopted the ISO15189:2012 quality management system to provide the best world class diagnostic services to clients and patients attending YRGCARE clinics and for the samples referred from other parts of the country/world. The laboratory has received accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) for the ISO15189:2012 and NABL specific criteria since the year 2008.

NABL is an autonomous body under the aegis of Department of Science & Technology, Government of India. NABL provides laboratory accreditation services to the laboratories which perform tests / calibrations in accordance with ISO 15189:2012 for medical laboratories.

Quality Policy of the laboratory

Conferences

The YRGCARE Infectious Diseases Laboratory has been organizing several scientific events and workshops/training programmes. GCLP workshops are being organized since 2010 and the Science Symposium on HIV & Infectious Diseases since 2008.

GCLP Workshop on International Standard (ISO15189:2012):

The Good Clinical Laboratory Practices (GCLP) was organized (12-14, March 2015) to outline the principles and procedures to be followed by medical laboratories involved in patient care and/or clinical research so as to provide consistent, reproducible, auditable, and reliable laboratory results; which contribute to good patient care and promote a positive attitude toward testing from a patient’s perspective. This workshop was designed to offer comprehensive guidance for those who are implementing GCLP in their laboratories.

The GCLP Workshop webpage can be accessed here :

International Science Symposium on HIV & Infectious Diseases (HIV SCIENCE2014):

The International Science Symposium (30^th January -1^st February 2014) was focused to cover various topics encompassing HIV epidemiology, pathogenesis, host-virus interactions, immune responses to infection, disease progression, opportunistic infections, co-infections, current treatment strategy, natural history, vaccines and other infectious diseases not limited to STDs, TB and viral hepatitis. The event was inaugurated by the HIV discoverer and Nobel Laureate, Prof. Françoise Barré-Sinoussi and Dr.Jack Whitescarver, Director, Office of AIDS Research, NIH,USA.

The International AIDS Society (IAS) organized an HIV Cure Satellite session in conjunction with the HIV SCIENCE 2014 on the first day evening. The satellite session was aimed at community representatives and scientists engaged and/or interested in HIV cure research, with the objective of presenting the key scientific knowledge in an accessible manner to enable participants to better understand the challenges for an HIV cure and the current research directions. The satellite also included a presentation on patient expectations from a community perspective and an outline of the IAS “Towards an HIV Cure” initiative.

The science symposium webpage can be accessed here :

Recognition

YRGCARE Infectious Diseases Laboratory (IDL) has been recognized by various national and international bodies as a premier research & development laboratory and also for the quality diagnostic laboratory services that it provides: