RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PRO FORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

TITLE OF THE TOPIC

“Seroprevalence and trends Of Common Transfusion - Transmitted infections amongBlood Donors”

DR. VAIBHAV AGARWAL

PG MD (PATHOLOGY)

AL-AMEENMEDICALCOLLEGE

BIJAPUR

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PRO FORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS: / DR.VAIBHAV AGARWAL
PG, MD (PATHOLOGY),
DEPARTMENT OF PATHOLOGY,
AL-AMEENMEDICALCOLLEGE,
BIJAPUR-586108, KARNATAKA
2. / NAME OF THE INSTITUTION: / AL-AMEEN MEDICAL COLLEGE,
BIJAPUR, KARNATAKA
3. / COURSE OF STUDY AND SUBJECT: / M.D. PATHOLOGY
4. / DATE OF ADMISSION TO THE COURSE: / MAY 2010
5. / TITLE OF TOPIC: / “Seroprevalence and trends Of Common Transfusion - Transmitted infections among Blood Donors”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR STUDY: VIDE ANNEXURE-I
6.2 REVIEW OF LITERATURE: VIDE ANNEXURE-II
6.3 OBJECTIVES OF STUDY: VIDE ANNEXURE-III
7. / MATERIALS AND METHODS:
7.1 SOURCE OF DATA: VIDE ANNEXURE-IV
7.2 METHOD OF COLLECTION OF DATA VIDE ANNEXURE-IV
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR
OTHER HUMAN ANIMALS? IF SO PLEASE DESCRIBE
BRIEFLY: VIDE ANNEXURE-IV
7.4 SAMPLE OF INFORMED CONSENT, BLOOD DONATION QUESTIONNAIRE & CONSENT FORM: VIDE ANNEXURE-V
7.5 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR
INSTITUTION IN CASE OF 7.3?
YES (COPY ATTACHED)
8. / LIST OF REFERENCES: / VIDE ANNEXURE-VI
9. / SIGNATURE OF CANDIDATE:
10. / REMARKS OF THE GUIDE: / This study helps in detecting prevalence of infectious diseases among the blood donors.
11. / NAME AND DESIGNATION OF:
11.1 GUIDE: / DR. B. B. SAJJANAR
M.D.,D.C.P. PATHOLOGY,
PROFESSOR,
DEPARTMENT OF PATHOLOGY, AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.2 SIGNATURE:
11.3 CO-GUIDE: / NOT APPLICABLE
11.4 SIGNATURE:
11.5 HEAD OF DEPARTMENT: / DR. A. M. PATIL
M.D.
PROFESSOR & HOD,
DEPARTMENT OF PATHOLOGY, AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.6 SIGNATURE:
12. / NAME OF THE DEAN: / DR. B. S. PATIL
12.1 REMARKS OF THE DEAN: / Any help required will be given by the institution.
12.2 SIGNATURE:

ANNEXURE-I

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR STUDY:

Blood is a scarce and life saving resource, however blood transfusion can be a source for transmitting life threatening infections if screening is not carried out properly.However, like all treatments it may resultin acute or delayed complications and carries the riskof transfusion–transmissible infections including HIV,Hepatitis B & C,Syphilis and Malaria. Appropriateclinical use of blood and supply of safe blood and bloodproducts can minimize such complications and risks. Itshould, therefore, be obligatory on those who areinvolved in transfusion of blood to a patient, that bloodtransfusion should not harm the patient. There arenumber of ways by which risk can be reduced and itincludes improving donor selection and direct screeningof blood for evidence of presence of infectious agentsor markers produced by them.

Any infectious agent that has an infectious blood phase potentially can be transmitted by blood transfusion. Factors that influence the risk of transmission by transfusion of an infectious agent and development of clinical disease in the recipient include prevalence and incidence of the agent in donors, duration of hematogenous phase, tolerance of the agent to processing and storage, infectivity and pathogenicity of the agent, and recipient's health status.This study wasundertaken to know the prevalence rate and incidence of infectiousmarkers among blood donors.

ANNEXURE-II

6.2 REVIEW OF LITERATURE:

Hepatitis B is one of most common infectious diseasesof the world and has infected 2 billion people worldwide;including an estimated 400 million chronically infectedcases. Individuals with chronic infection have a highrisk of developing liver cirrhosis and hepatocellularcarcinoma. Hepatitis C virus (HCV) infection is anothercommon chronic blood borne infection with an estimated3.9 million persons infected by the virus and a high rateof development of liver cirrhosis. Infection by hepatitisB virus (HBV) and HCV causes serious mortality,morbidity and financial burden and are thus a majorglobal health problem. [1]

Demographically the second largest country in theworld, India has also the third largest number ofpeople living with HIV/AIDS. As per the provisionalHIV estimate of 2008-09, there are an estimated22.7 lakh people living with HIV/AIDS in India. TheHIV prevalence rate in the country is 0.29 percent(2008-09) and most infections occur throughheterosexual route of transmission. However inthe north-eastern region, injecting drug use is themajor cause for the epidemic spread.[2]

In India, nine Anopheline vectors are involved in transmittingmalaria in diverse geo-ecological paradigms. About 2 millionconfirmed malaria cases and 1,000 deaths are reported annually,although 15 million cases and 20,000 deaths are estimated byWHO South East Asia Regional Office. India contributes 77% ofthe total malaria in Southeast Asia. Multi-organ involvement/dysfunctionis reported in bothPlasmodium falciparumandP. vivaxcases.Most of the malaria burden is borne by economically productiveages. The states inhabited by ethnic tribes are entrenched withstable malaria, particularlyP. falciparumwith growing drugresistance. [5]

Like the developed countries, in India too the bacterial STIs like chancroid and gonorrhea are declining, while viral STIs like HPV and herpes genitalis are on an upswing. The overall decline in the prevalence of STIs has to be interpreted with caution, however. [6]

Among various STDs, prevalence patternof syphilis in the community is pivotal and has beenconventionally assessed by routine serological methodin both symptomatic and asymptomatic populations. [7]

According to GAGANDEEP KAUR et al , Of the 42,439 units of blood collected over a 5- year period, 19 118 (45%) were from voluntary and 23 321(55%) from replacement donors. There were 1603 seroreactive cases (3.8%). These included 250 with HIV (0.6%), 734 with hepatitis B surface antigen (HBsAg; 1.7%), 337 with hepatitis C virus (HCV; 0.8%) and 282 (0.7%) with VDRL (Venereal Diseases Research Laboratory)reactivity.[3]

According to Prasun Bhatacharya et al - A statistically significant increase in theprevalence of HBV (1448 vs 1768, P < .001), HIV (262vs 374, P < 0.001), HCV (314 vs 372, P = 0.003) andsyphilis (772 vs 853, P = 0.001) infections was notedamong blood donors of Kolkata West Bengal in 2005 ascompared to 2004. Moreover, the exploratory study on1027 HBsAg negative donors revealed that 188 (18.3%)of them were anti-HBc positive out of which 21% werepositive for HBV DNA.

HIV antibody testing is used to screen for and diagnoseHIVinfections. Early treatment of HIV infection and immune system monitoring can greatly improve long-term health. Also, knowing your HIV status may help you change behaviors that would put you and others at risk.Antibodiesto the HIV virus are often detected by a screening test called anELISA. The ELISA test is repeated if positive. The ELISA method is verysensitivebut requires another test, aWestern Blot, to confirm the results becausefalse positivescan occur. There are several rapid tests available in which results are generated in about 20 minutes. However, these too must have confirmatory testing before a final diagnosis can be made. Antibody testing will not detectHIVimmediately after exposure, during the window before the development ofantibodies. If a person is tested too soon, the result may be negative despite the fact that the person is infected (false negative). In this case, he may be tested using ap24 antigen testthat can detect actual viral protein in the blood 1 to 3-4 weeks after exposure or anHIV RNA test (viral load)that detects the presence of the virus, not the antibody response to it. Or he should have another HIV antibody test in 3–6 months from the time of a possible exposure to the virus.

Hepatitis Bandhepatitis Care serious global health concerns. They are highly contagious infections of the liver that are spread through contact with blood or other body fluids from infected persons. Both can lead tochronicinfections and, in many cases, serious complications such ascirrhosisor liver cancer. The World Health Organization (WHO) estimates that about 2 billion people worldwide have been infected with hepatitis B virus (HBV), about 400 million are chronically infected, and that about 600,000 people die each year from consequences related to infection. Hepatitis C virus (HCV) infections are common worldwide with approximately 3% of the global population chronically infected, according to WHO. About 1 in every 12 people worldwide has chronic infection with either HBV or HCV. While several different types of laboratory tests are currently available to detect these diseases, researchers continue to work to develop faster, simpler, and more cost-effective tests. The number of rapid tests for HBV has increased in recent years.it employs simple "dipstick" technology to test for the presence of a protein of HBV (called hepatitis B surface antigen ( HBsAg ) in blood. The test's convenient and relatively low-tech design makes it suitable for use in areas of the world that lack resources for testing methods that require sophisticated instrumentation and special training.Rapid test for HCV detects the presence of HCVantibodiesin blood and is approved for use in screening individuals 15 years of age or older who have been exposed or who are at an increased risk of infection. The new test employs a test strip so it does not require instrumentation or extensive training to use. It provides results in about 20 minutes. However, a positive test requires confirmation by a second test in order for a diagnosis to be made.Hepatitis B and C continue to be major health threats throughout the world because so many people don't know they have the disease. The simple yet effective design of these and other rapid tests may prove to be helpful in overcoming the barriers that prevent people from getting tested.

Sexually transmitted diseases (STDs), also called sexually transmitted infections (STIs) or venereal diseases, are infections caused by organisms that can be transmitted from one person to another through sexual activity and intimate contact.Since many STDs have few or no symptoms, it is possible for a person to have an infection and to infect others without either of them knowing it. For this reason, screening for these infections is important to assure early detection and prompt treatment.Syphilis is another bacterial infection that can be easily missed. The first symptom is a painless chancre at the site of exposure that will disappear on its own. Syphilis can be treated with antibiotics. However, if left untreated, the disease can spread throughout the body over the course of many years and cause considerable organ damage. There are several stages with syphilis. The primary stage begins about 2-3 weeks after being infected. One or more sores, called chancres appear, usually on the part of the body exposed to your partner's chancre, such as the penis or vagina. However, the chancre is usually painless and may go unnoticed, especially if it is in the rectum or on the cervix, and disappears within 4-6 weeks.

Secondary syphilis begins 2-8 weeks after the chancre first appears. It is marked by a skin rash that often is rough, red, and spotted, appearing frequently on the palms of the hands and the bottoms of the feet. There may be other symptoms as well, such as fever, fatigue, swollen lymph glands, sore throat, and body aches. If untreated, syphilis may continue into a latent stage, during which an infected person has no symptoms but continues to have the infection, and this stage can last for years. If still untreated, about 15% of people will develop the complications of late, or tertiary, syphilis. In these cases, the bacteria can damage the heart, eyes, brain, nervous system, bones, joints, or almost any other part of the body. This stage can last for years, with the final stage leading to mental illness, blindness, other neurological problems,heart disease, and death.

There are several methods that can be used to test for syphilis. One method used in diagnosis of early cases involves looking for the bacterium in scrapings from the chancre using a special instrument called a dark-field microscope. Other methods require a blood sample in whichantibodiescan be detected. These include:

  • For screening – VDRL which stands for “venereal disease research
  • Laboratory test and Rapid Plasma Reagin Test (RPR)

The FTA-ABS test is used to confirm a positive VDRL or RPR screening test. Screening tests for syphilis are not highlyspecificand may give afalse positiveresult. For example, havingHIV,Lyme disease, malaria,lupus, or certain types of pneumonia may cause a false positive result on the VDRL and RPR tests. Positive tests should be confirmed with a more specific test method, such as FTA-ABS.

Malaria is caused by a parasite called Plasmodium, which is transmitted via the bites of infected mosquitoes. In the human body, the parasites multiply in the liver, and then infect red blood cells.Symptoms of malaria include fever, headache, and vomiting, and usually appear between 10 and 15 days after the mosquito bite.

Malaria Testis a rapid laboratory antigen test that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick.A rapid test for malaria that can produce results in 15 minutes. Standard tests take far more time and require identifying parasites in a blood sample using microscopy.The new product can differentiate Plasmodium falciparum, which is the most dangerous malaria parasite, from the other three Plasmodium species that can infect humans. Negative results with the test will still need to be confirmed using microscopy.

ANNEXURE-III

6.3 OBJECTIVES OF STUDY:

  1. To calculate prevalence of HIV, hepatitis B & C, syphilis and malaria
  2. To calculate incidence of HIV, hepatitis B & C, syphilis and malaria
  3. To find the age incidence and sex incidence of HIV, hepatitis B & C, syphilis and malaria

ANNEXURE-IV

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

All voluntary blood donors who meet the blood donation eligibility criteria who are referred to the Blood Bank, Al-Ameen Medical College Hospital, Bijapur.

7.2 METHODS OF COLLECTION OF DATA:

Proforma details of patients medical history, preliminary health checkup for blood donation and eligibility criteria for donation of blood . Blood samples from eligible candidates referred to the Blood Bank, Al-Ameen Medical College Hospital, Bijapur will be evaluated for the study.

  1. BLOOD COLLECTION:

Blood samples from the eligible donors will be collected by phlebotomy in blood collection bags of 350ml or 450ml capacity (single, double, triple or quadruple bags) containing CPD or CPDA – 1 as anti coagulant preservative solution. All precautions mentioned in the SOP of Blood Bank, Al Ameen Medical College, Bijapur will be adhered.

  1. DETECTION OF HIV:
  2. RAPID
  3. ELISA
  4. DETECTION OF HEPATITIS B & C:
  1. DETECTION OF SYPHILLIS
  2. DETECTION OF MALARIA
  3. RAPID
  4. PERIPHERAL SMEAR METHOD
  5. SAMPLE SIZE:

All blood units collected during from 2007 – 2012 ( 5 Year study, 3 years retrospective & 2 years prospective) at Blood Bank, Al Ameen Medical College, Bijapur

7.2.2INCLUSION CRITERIA:

Any donor meeting all criteria’s for eligibility of blood donation as mentioned in SOP, Blood Bank, Al Ameen Medical College, Bijapur

7.2.3EXCLUSION CRITERIA:

  1. Any donor not meeting all criteria’s for eligibility of blood donation
  2. Any eligible donor having any kind of reaction during the blood donation procedure will be excluded from the studies
  3. Any defects found in the sample collected ( Bag Leakage, Improper Maintenance Of Cold Chain During Transportation, Preservation Defects, Temperature Defects, Any Undesirable Physical And Biochemical Changes In Stored Blood)
  4. STATISTICAL METHODS:

Statistical analysis of collected data will be made as per objectives.

7

7.1

7.2

7.3DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY:

  1. Phlebotomy
  2. Analysis of collected blood sample for HIV,Hepatitis B & C, Syphilis and Malaria

ANNEXURE-V

7.4 SAMPLE INFORMED CONSENT FORM:

AL - AMEENMEDICALCOLLEGE, BIJAPUR, KARANATAKA

RESEARCH INFORMED CONSENT FORM

TITLE OF THE PROJECT:

“Seroprevalence and trends Of Common Transfusion - Transmitted infections among Blood Donors”

PG GUIDE’S NAME: DR. B. B. SAJJANAR

PRINCIPAL INVESTIGATOR: DR. VAIBHAV AGARWAL

PURPOSE OF RESEARCH:

I have been explained about the reason for doing the study and selecting me as a subject of the study. This study is for the better understanding of the incidence and prevalence of HIV, hepatitis B & C, syphilis and malaria among blood donors.

RISK AND DISCOMFORTS:

I understand that I may experience some pain or discomfort during the procedure. The procedure and complications have been explained to me.

BENEFITS:

I understand that my participation in the study will have no direct benefits to me other than potential benefit towards humanity.

ALTERNATIVES:

Even if you decline the participation in the study, you will get the routine line of management.

CONFIDENTIALITY:

I understand medical information produced by this study will become part of my hospital record and will be subject to the confidentiality and privacy regulations of the said hospital.

If the data are used for publication in the medical literature for teaching purposes, no names will be used, and other identifiers, such as photographs and audio or videotapes, will be used only with my special written permission. I understand I may see the photographs and videotapes and hear the audio tapes before giving this permission. For this purpose every effort will be made by publishing person to contact me in the address furnished by me through postal communication. If no response is received within a reasonable time, all the identities will be removed from the photographs and case report before being submitted for publication.

REQUEST FOR MORE INFORMATION:

I understand that, I may ask more questions about the study at any time. Researcher is available to answer my questions or concern in this research period. I understand that I will be informed of any significant new findings discovered during the course of this study, which might influence my continued participation.

REFUSAL OR WITHDRAWL OF PARTICIPATION:

I understand that my participation is voluntary and I may refuse to participate or my withdraw consent and discontinue participation in the study at any time without prejudice to my present or future care at this hospital. I also understand that researcher may terminate my participation in the study at any time after I have been explained the reasons for doing so, if this is appropriate.