( The Newsletter of )

VOLUME 1, 2014 ISSUE NO. 7 April, May, June - 2015

Association of Practicing Pathologists (India)

PATHFINDERPATHFINDERChief Editor : • Editorial board : Dr. Indumati Gopinathan Dr. Milind Bhide, Dr. Pratik Jariwala

Advisory Panel : Dr. Meena Desai, Dr. Shaila Khubchandani

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CONFERENCE SPECIAL EDITION

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Dear fellow pathologist,

As the intense heat and

humidity gradually paves the

way for welcome monsoons,

greetings from “Pathfinder”!

H o p e y o u r j o u r n e y a n d

association with AAPI has been

significantly valuable ! The managing committee and

the conference committee have been working

overtime to streamline CMEs, arrange for credit

points, making relevant representations and to top it

all enabling an extraordinary annual conference for

our fraternity .We at the editorial board are certain

that going by the nature of preconference workshops

and seminars and the content of the conference, the

registration is going to be a record !

Sponsors for a value added conference at a proper

venue are vital for its success. In response to the

thumping success of last years annual conference the

response of sponsors has been encouraging. As a

departure from the usual, this issue of Pathfinder is

dedicated largely to the sponsors with their inputs.

The usual features of humor, famous pathologists and

relevant topics like Nucleic Acid testing (NAT)

continue. We are certain that you are able to

download our newsletters from our website .Here s

wishing you a great conference over the 13th and

14th of June !!

Happy reading,Dr. Indumati Gopinathan

Editor in Chief

INSIDE

Association of Practicing Pathologists (India)

Ÿ Famous Pathologists : Series Page 3

Ÿ Nucleic Acid Testing (NAT) Page 5

Ÿ The Funpath Page 6

Ÿ Membership Form Page 8

Ÿ Delivering the Promise Page 10

We acknowledge the following sponsors who have enabled this issue of Pathfinder

1. Beckman Coulter

2. Roche Diagnostics India Pvt. Ltd.

3. CPC Diagnostics

4. Mindray Medical India Pvt. Ltd.

5. Ortho Clinical Diagnostics

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Pathologist Dr. Robin Warren

Date of birth :11th June 1937

Australian pathologist and Nobel Laureate, Robin Warren, needs no introduction. He won the Nobel Prize in Medicine in 2005 for the discovery of the bacterium Helicobacter pylori and its role in the gastritis and peptic ulcer disease.

w Graduating in Medicine from the University of Adelaide, he joined as Junior RMO at the Royal Adelaide Hospital. He could not get registrars post in psychiatry.

w He then took up the profile of Registrar in Clinical Psychology at the Institute of Medical and Veterinary Science, a part of Royal Adelaide Hospital. The job profile included reporting on blood smears and bone marrow, examining faeces for parasites, examining urine and testing skin and nails for fungus. It was during this time that his interest in pathology was generated.

w A year later, a temporary lecturer in Pathology at the Adelaide University he researched on morbid anatomy and histopathology. Inspired and interested by the subject, he gained membership at the new College of Pathologists of Australia.

w As Registrar of Clinical Pathology at the Royal Melbourne Hospital he gained tutelage under Dr. David Cowling and Dr. Bertha Ungar which enabled him to study further in haematology and microbiology. By the end of his four years in Melbourne he became a full-fledged pathologist.

w It was while trying to obtain a position as a pathologist at Port Moresby in Papua New Guinea

that he was offered job by Professor Rolf ten Seldam, the Professor of Pathology at the University of Western Australia and the Royal Perth Hospital.

w In 1968, he moved to Perth and took up the position at the Pathology department in the Royal Perth Hospital and stayed till his retirement in 1999.

w In 1970s, he developed an interest in the new gastric biopsies that were becoming popular. During this time, peptic ulcers were believed to have been caused due to excess of gastric acid which again was the result of a stressful lifestyle.

w In 1979, he first observed the presence of spiral shaped bacteria in a biopsy of a stomach lining in a patient. The finding was in sharp contrast with the conventional belief that bacteria could not survive in the highly acidic environment and thus his reports were rebuffed by scientists.

w In 1980, he befriended Barry Marshall and the two agreed to take a clinical-pathological study of the same. Both began to work jointly to come up with the clinical significance of the bacteria. In their study of 100 stomach biopsies they found that the bacteria were present in almost all patients with gastritis, duodenal ulcer, or gastric ulcer. At the end of seven years of study, the duo finally deduced that the Helicobacter pylori bacteria were involved in causing the illness and when properly treated, recurrence of peptic ulcer was rare. He proved the same at the University of Western Australia.

w The duo developed a convenient diagnostic test (C-urea breath-test) for detecting the same in ulcer patients. They paved the way for treatment consisting of antibiotics and acid-secretion inhibitors for curing peptic ulcer disease.

w It was in 1990 that the two pathologists were finally recognized by the medical community. In 1999, following his retirement, he pursued his hobby of photography. However, with the distinctive distinction of being a Nobel laureate , he resumed his medical career, attending meetings and presentations.

FAMOUS PATHOLOGISTS : SERIES

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Nucleic acid testing (NAT) is a molecular technique for screening blood donations to reduce the risk of transfusion transmitted infections (TTIs) in the recipients, thus providing an additional layer of blood safety. It was introduced in the developed countries in the late 1990s and early 2000s and presently around 33 countries in the world have implemented NAT for human immunodeficiency virus (HIV) and around 27 countries for hepatitis B virus (HBV).

NAT technique is highly sensitive and specific for viral nucleic acids. It is based on amplification of targeted regions of viral ribonucleic acid or deoxyribonucleic acid (DNA) and detects them earlier than the other screening methods thus, narrowing the window period of HIV, HBV and hepatitis C virus (HCV) infections. NAT also adds the benefit of resolving false reactive donations on serological methods which is very important for donor notification and counseling. In a recent Malaysian study] 1388 donor samples were tested by serology as well as NAT, authors found 1.37% samples reactive on standard serology methods but non-reactive by NAT. These samples were confirmed to be “false reactive” on confirmatory serological tests.

NAT for HCV was first done in Germany in 1997 on pooled samples of 96 blood donations

Subsequently pool size has decreased to to 16, 8 or 6 donation samples. MP-NAT may have the advantage of being cost-effective, but there are some limitations. The whole size of pooled blood donations is blocked until the NAT report is available. Moreover, as viral nucleic acid concentration gets diluted in the large pool of samples, the sensitivity of NAT might decrease and if a pool is tested reactive, the whole pool requires resolution to identify the single positive unit and this process requires an additional step of handling, additional time for testing and hence delay in the release of units. NAT is also available for testing each donation individually (ID-NAT). This format of NAT seems more sensitive as shown by data from many studies where ID-NAT has been compared to MP-NAT with pools of 16 or 8 or 4 samples and if a unit is ID-NAT reactive, donation number is identifiable for performing discriminatory test. That single unit is removed from the inventory, releasing other units on time. However, this has limitations of higher cost. In a study conducted in United States, it was seen that

over a 10-year period, approximately 66 million donations were screened with 32 HIV (1:2 million) and 244 HCV (1:270,000) NAT yield donations identified. HCV prevalence among first time donors decreased by 53% for 2008 compared with 1999. The introduction of HBV NAT in the United States, along with the HBV vaccination policy made a measurable contribution to blood safety and decreased residual risk of HBV infection. In United Kingdom, NAT has reduced the risk of HCV by 95% and that of HIV by 10% The American Red Cross implemented automated triplex NAT for HIV, HCV and HBV in June 2009. They analyzed their results of the initial year of testing and found that the yield of MP-NAT (MP16) had little measurable impact on blood safety in detecting seronegative donations. Other studies showed that sensitive, ID-HBV NAT detects significantly more DNA-positive, hepatitis B surface antigen (HBsAg)-non-reactive donations than MP-NAT, regardless of the anti-hepatitis B core status of the donor. In a pilot study of 18 months from China, ID-NAT was compared with enzyme immunoassays. It was observed that HBV yield rate in their population is 1:1056 for blood donations. In a study from Egypt 5 window period HCV donations were identified among 15,655 1st time donors (yield 1:3100). NAT screening may thus prove to be more beneficial where the seroprevalence of transfusion transmissible infectious agents is high, as is the case in most developing countries.

In India, mandatory blood screening for HBV, HIV and HCV is done by serological tests for HBsAg and antibodies to HIV 1/2 and HCV. The screened seronegative donations are still at risk for TTIs and thus, need for a sensitive screening test arises to decrease this residual risk which has been reduced significantly over the last two to three decades in western countries where NAT has been implemented. NAT testing has been started in few centers in India, but it is not a mandatory screening test for TTIs as per Drug and Cosmetics Act, 1940 and the rules therein Major barriers in implementing routine NAT testing in India is its high cost and lack of technical expertise in most of the blood centers.

In the present issue of the journal three articles on NAT - one review and two original studies highlight the current dilemma for India. The review article by

NUCLEIC ACID TESTING (NAT)

Cont. on pg. 6

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Shyamala draws attention to the high seroreactivity of HBV, HCV and HIV in multitransfused thalassemic patients which indicates window period transmission of TTIs by seronegative units. A case for ID-NAT testing has been put forward. The article by Chatterjee et al. has compared the sensitivity of ID- and MP-NAT testing as assessed by dilution of NAT yield samples. The authors observed that samples with high viral load were detected by all dilutions, but 67% of samples of low viral load are missed by MP-NAT and concluded that ID-NAT is ideal methodology for TTI screening. In a study by Shivaram seronegative samples were tested by in-house MP-NAT, using reverse transcriptase-polymerase chain reaction over a period of 5 years and found a nominal increase in cost per test. Their NAT yield was 0.0006%, low as compared to studies from other parts of India. However, the analytical sensitivity of the in house MP-NAT had not been established and the results may not represent the true yield.

In India blood centers are gradually introducing NAT to provide safe blood to their patients. First multicenteric study was done by Makroo et a] where a total of 12,224 samples along with their serological results were obtained from eight blood banks in India and were tested individually manually by procleix ultrio assay for HIV 1, HCV and HBV. They observed eight NAT yield cases. According to a study from the western part of India combined NAT yield (NAT reactive/seronegative) for HIV, HCV and HBV was 0.034% (1 in 2972 donations) which is high when compared to studies from developed countries. In

another study conducted in north India, 18,354 donors were tested by both ID-NAT and fourth generation enzyme-linked immunosorbent assay (ELISA), 7 were found to be NAT-positive but ELISA-negative (NAT yield) for HBV and HCV. The prevalence of NAT yield cases among routine donors was 1 in 2622 donations tested (0.038%). This high yield of NAT is due to the high prevalence of TTIs in India, further highlighting the need for NAT in India. In another study from a tertiary care center from north India ID NAT results were compared to serological method for 73,898 samples, 1.49% were reactive by NAT, HIV-1 (0.09%), HCV (0.25%), 1.05% were reactive for HBV only and around 0.08% were HBV-HCV co-infections with a combined yield of 1 in 610 donations (total 121 NAT yields).

NAT is a highly sensitive and advanced technique which has reduced the window period of HBV to 10.34 days, HCV to 1.34 days and HIV to 2.93 days but it is highly technically demanding, involving issues of high costs, dedicated infrastructure facility, equipments, consumables and technical expertise. The need for NAT depends on the prevalence and incidence rate of infections in blood donor population, available resources and the evidence of benefit added when combined with serology tests. Hence the decision of starting NAT should be considered when basic quality assured blood transfusion system is already in place such as volunteer base for blood donation, provision of donor self-deferral, donor notification and counseling along with quality assured sensitive serological methods for testing TTIs.

THE FUNPATH

A doctor stops a fellow physician in the hallway. “I have a patient with AIDS, Chlamydia, Gonorrhea AND Syphilis.”

“Geez, that’s horrible. What do you do for a patient like that?”

“I have him on a special diet of pancakes and flounder.”

“Pancakes and flounder! My god, that’s revolutionary! Does it work?”

“I don’t know. It’s the only thing that’ll fit under the door.”

A bacteria walks into a bar and and the barkeeper said “We dont serve bacteria here

“But I work here” , the Bacteria said, I am Staph!

Cont. from pg. 5

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MIOT Hospital was started in the year 1999 with bed strength of 200 and today it is a 1000 bedded quaternary care hospital, catering to 46 different specialities including the Renal, Liver and bone marrow transplants. With the growth in the hospital size and ever increasing workload, Diagnostic Laboratory service at the hospital was under constant pressure. Patients were demanding and more so were the Physicians who depend on laboratory investigations for critical clinical decisions and hence requested for reports at the shortest possible time with total reliability. In this journey of our growth, with the increase in the sample flow there was a need to shorten the turnaround time (TAT) in sample processing, without compromising on the quality of the results.

The laboratory situation in 2008 was like this:

The Hospital Management, needed to upgrade the laboratory infrastructure with a vision to: a) Support the ever growing workload & demand from the patients & physicians b) Upgrade the laboratory to handle projected growth for the next five years

It was the responsibility of the Laboratory Director to find a suitable solution which could cater to growing needs of the Hospital Laboratory. He decided to look around for a solution suitable to achieve these goals. The following points were considered to be high priority:

1. Powerful system capable of delivering high performance 2. Cost effective analysis 3. Expansive, standardized menu with option of open system with esoteric and electrolytes menu 4. Easy to handle user interface, customer friendly system with minimum user maintenance 5. Efficient systems with a history of minimum downtime 6. Stat options with random access and continuous sample load 7. Short turnaround time of the assays 8. Results integration to LIS and HMS 9. Improved safety design 10. Reflex testing and flagging for the serum index 11. Scalability of the menu and also integration with immunoassay or chemistry module in future 12. Easy maintenance with good service support

It was a herculean task to identify a system which could meet all the specifications set out. Finally the hospital management & the Laboratory director settled with Beckman Coulter AU 5800, which could handle all the priorities enlisted.

The system could provide solution to the requirements of all the stake holders involved.

DELIVERING THE PROMISE : RESULTS MATTER

• Primary tube to Automated chemistry analyser without electrolyte analysis• Secondary tube to other equipment (with aliquoting)

• Chemistry, electrolytes ,esoteric testing in three different machines• Sample traceability, spilt sample, secondar y tubes, higher turn around time

• Delay due to manual transfer of data• Sample spiltting was causing delays and decreasing productivity• Machine maintenance, machine breakdown was another burden to handle

Cont. on pg. 11

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Reliable results within short span of time

a) Cost effective testing, minimum down time and workhorse of the lab. b) Ease & economy of inventory management (one system reagents, consumables &

maintenance) c) Reduction in personnel handling multiple instruments

a) Standardised testing b) Consolidation of test menu on single machine c) No need for sample splitting (primary tube moving in to total chemistry and esoteric

testing). d) Reliable results with good quality management options. e) Decrease in turnaround time (TAT), efficient management of the samples. f) Optimal utility of the technical staff

Fast, Quality & reliable reports, better clinical decisions, reducing their stay at the hospital

“The overall experience of the laboratory with AU 5800 is amazing and our technical staffs are in love with the system, “Machines are our SOULMATES & working partners in the laboratory. We depend on them day in and day out. Their performance decides the productivity of the laboratory. At the same time, ‘each Specimen is a Patient’. We need to value our commitment for a safe and reliable report, Patient’s needs need to be Put First” says Dr. C. N. Srinivas, Director of Laboratory services at MIOT Hospitals.

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Cont. from pg. 10

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