A Pilot Study to establish and evaluate the CHUV Assay as a Cost-Effective tool for genotyping human Papillomavirus in HIV infected Women.

Pallavi, Ravindra Baliga (2013) A Pilot Study to establish and evaluate the CHUV Assay as a Cost-Effective tool for genotyping human Papillomavirus in HIV infected Women. Masters thesis, Christian Medical College, Vellore.

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Abstract

INTRODUCTION : Cancer of the uterine cervix is one of the leading causes of cancer death among Women worldwide. The estimated number of new cervical cancer cases per year is 500,000, of which 79% occur in developing countries. Cervical cancer is ranked Highest or second-highest among cancers in women in developing countries. In India, Every year 132,082 new cases of cervical cancer cases are diagnosed and 74,118 Women die from the disease. Thus, India has one-fourth of the global burden of Cervical cancer. AIM & OBJECTIVES : AIM: To establish and evaluate the CHUV assay as a cost-effective tool for HPV detection And genotyping in HIV-infected women. OBJECTIVES: 1. To establish a cost-effective, in-house reverse hybridization Assay (CHUV assay) as a tool for HPV detection and genotyping in HIV-infected women. 2. To compare the accuracy indices of the CHUV assay with a licensed commercial assay (Linear Array, Roche Diagnostics). METHODS : Study design: Prospective study of diagnostic test accuracy. Study duration: March 2011-July 2012 Study samples: Cervical brush samples from 50 HIV-infected women and 43 WHO reference samples (HPV purified plasmid DNA). All samples were tested by both assays. PCR followed by genotyping was done for all samples. Index test: CHUV reverse hybridization assay – genotype detection is by autoradiography in a dark room. Gold standard: Linear Array (Roche Diagnostics) -genotype detection is by colorimetric detection. The Accuracy indices – sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated with a 95% confidence interval for the CHUV assay in comparison to the Linear Array. RESULTS AND CONCLUSIONS : The CHUV assay in comparison to the Linear Array showed a sensitivity of 91%, specificity of 52% and a moderate agreement for all samples that were compared. It was not efficient in detecting multiple-genotype combinations. However, most high-risk HPV types were identified and the entire range of genotypes in the WHO reference panel was detected. The CHUV assay had an acceptable sensitivity but it lacked specificity for HPV detection. Despite the lower rates of detection of multiple infection, satisfactory results were obtained with the WHO reference samples and the ability of the assay to identify the entire range of genotypes suggests that it can be an efficient tool for genotyping.

Item Type: Thesis (Masters)
Uncontrolled Keywords: CHUV Assay ; Cost-Effective Tool ; Human Papillomavirus ; genotyping ; HIV ; Infected Women ; Pilot study.
Subjects: MEDICAL > Microbiology
Depositing User: Subramani R
Date Deposited: 14 Aug 2017 01:06
Last Modified: 14 Aug 2017 01:07
URI: http://repository-tnmgrmu.ac.in/id/eprint/1325

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