Monday, August 2, 2010

suitably designed Informed Consent Form (ICF)

The study was approved by the Institutional ethics committee at kasturba hospital, manipal. A suitably designed Informed Consent Form (ICF) in different languages namely English, Kannada and Malayalam was prepared and used for the purpose of the study. In order to record the data for the study, a separate Case Record Form (CRF) was designed and used, which contains the details of the patients demographics, medical history, medication history, final diagnosis, laboratory investigations, study specific investigations, patient outcome analysis chart, adverse event reporting card, discharge medication and details of follow up visits. The American Urological Association Symptom Score3 (AUASS) was used to assess the severity of urinary symptoms and to check the effectiveness of the treatment. The AUA symptom index questionnaire consists of 7 questions. For the purpose of this study questions 2, 4 and 7 were assigned to irritative symptoms, while questions 1, 3, 5 and 6 were assigned to obstructive symptom sub scores. Total scores were classified as mild 0 to 7, moderate 8 to 19 and severe 20 to 35 symptoms, as recommended by the AUA measurement committee3. This questionnaire has been adopted worldwide and it is also known as the International Prostate Symptom Score (IPSS). The quality of life questionnaires4 were classified as delighted with score (0), pleased with score (1), mostly satisfied with score (2), mixed with score (3), mostly dissatisfied with score (4), unhappy with score (5) and terrible with score (6) was used to assess the quality of life of the patient with bladder outlet obstruction.This was a randomised controlled study conducted in the Dept. of Urology of Kasturba Hospital, Manipal from September 2008 to April 2009. Our first step was to identify the female patients with bladder outlet obstruction and male patients with BPH during ward rounds or with the help of the physician. Once the patient was identified, they were enrolled according to the study criteria and subject information sheet was explained in detail to the patient or patient‟s legally acceptable representatives and written inform consent was obtained from qualified patients prior to their enrolment. A detailed history, clinical examination, study specific investigations which includes Maximum Flow Rate (MFR), Post Voidal Residual Volume (PVR) and bladder thickness was done and the follow up details for all the patients was recorded in the CRF followed by assessment of American Urological Association symptom score (AUASS). The treatment patterns were analyzed with respect to medical treatment or surgical procedures adapted to the patient.


Bioelectronic DNA detection involves forming an electronic circuit mediated by nucleic acid hybridization and it serves as the basis for a DNA detection system called eSensor™ [1-4]. This system uses low-density DNA chips containing electrodes coated with DNA capture probes. Target DNA present in the sample hybridizes specifically both to capture probes and ferrocene labeled signal probes in solution thereby generating an electric current. Currente Sensor DNA chips contain as many as 36 electrodes for simultaneous detection of multiple pathogens from a single sample.

Many pathogens cause both acute and chronic disease at relatively low copy number and may be difficult or impossible to propagate in culture. Thus, most pathogen detection systems rely on nucleic acid amplification by using polymerase chain reaction (PCR). One highly effective amplification strategy targets conserved sequences among the family of organisms of interest. Such broad-range PCR strategies have been used to identify and characterize several known and previously uncharacterized bacteria [5,6] and viruses [7,8]. In order to maximize the utility of these effective pathogen nucleic acid amplification systems, amplification needs to be coupled with rapid, sensitive, and specific detection. Bioelectronic DNA detection by use of the eSensor chip might fulfill this need.

Human papillomaviruses (HPV) serve as an ideal model system for determining the efficiency and feasibility of eSensor DNA detection technology since there are at least 30 distinct genital HPV types that can be effectively amplified with broad-range consensus PCR primers. We designed two eSensor chips, each containing 14 probes specific for the conserved L1 region of the HPV genome. We evaluated clinical cervical cytology samples known to contain one or more HPV types. The eSensor DNA detection platform successfully detected the correct HPV type in most of these clinical samples, demonstrating that the system provides a rapid, sensitive, specific, and economical approach for multiple-pathogen detection and identification from a single sample.Background We used human papillomaviruses (HPV) as a model system to evaluate the utility of a nucleic acid, hybridization-based bioelectronic DNA detection platform (eSensor) in identifying multiple pathogens.