6 JN-QC-SPOT Rapid HIV Test Intended for use by properly trained personnel as a screening test for the rapid detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) subtypes A-J and ‘O’ in plasma, serum, and whole blood.
7 JN-QC-SPOT Rapid HIV Test HospitalsLaboratoriesMedical ClinicsPhysicians' officesEmergency care situations where standard tests are not practical or available
8 JN-QC-SPOT Rapid HIV Test Product Goals The ability to detect HIV-1 antibodiesThe ability to detect HIV-2 antibodiesThe ability to detect HIV-1, group O antibodiesSensitivity and specificity of %Simple and quick
9 JN-QC-SPOT Rapid HIV Test Sensitivity – The ability to detect positive samplesSpecificity – The ability to distinguish between positive and negative samples
10 JN-QC-SPOT Rapid HIV Test Development History Development Project began April 1996Configuration– November 1996HIV Whole Blood Format Prototype completed – September 1997Whole Blood Format – February 1998Combined Serum/plasma and Whole Blood Format – July 1998
11 JN-QC-SPOT Rapid HIV Test Clinical Trials History First Configuration and Evaluation by Clinical Studies Conducted at- Vanderbilt Medical Center, Nashville, TN, USA- Duke University Medical Center, Durham, NC, USA.Second Evaluation by – October 1998Caribbean Epidemiology Center, Pan American Health Organization, World Health Organization (WHO),Port of Spain, TrinidadThird Evaluation by– February 1999Kenya Medical Research Institute, WHO East and Central Africa Reference Laboratory, Nairobi, Kenya- CONTINUED
12 JN-QC-SPOT Rapid HIV Test Clinical Trials History Clinical Trails with Live HIV patients– January 1999- Martin Luther King/ Drew Medical Center,Los Angeles, CA, USA.Fourth Evaluation by – February 2000- South African National Institute of Virology,Sandringhar, S. AfricaFifth Evaluation by – September, 2000- Centro Colaborador Para El Sida (CNRS)World Health Organization,Buenos Aires, ArgentinaSixth Evaluation by – July, 2002- National AIDS Reference Laboratories (NARL)Infectious Diseases Research Centre (IDRC)Institute of Medical ResearchKuala Lumpur, Malaysia
14 JN-QC-SPOT Rapid HIV Test Performing the Assay Results after 15 minutes
15 JN-QC-SPOT Rapid HIV Test Field Evaluations and Results
16 JN-QC-SPOT Rapid HIV Test 2001 Goals Complete Validation ProcessContinue with overall GMP Requirements for UK, India and BelgiumSubmit clinical protocols to investigative sitesBegin clinical studies and collect data in Africa, S.Asia and S.America.Analyze and summarize data
17 JN-QC-SPOT Rapid HIV Test Mother-to-Infant Transmission of Human Immunodeficiency Virus (HIV) The spectrum of pediatric HIV disease has changed significantly over the last few years. In recent years, the pathogenesis of vertical HIV infection has been thoroughly investigated. Findings have indicated that transmission is due to multi-factorial mechanisms, including maternal virus burden, phenotype and genotype, maternal immunologic responses, and obstetrical events during labor and delivery. Studies demonstrate that the majority of HIV vertical transmission probably occurs at the time of birth. However, perhaps one-third of cases are infected prior to delivery, and in breast-feeding populations up to 20% of infected women may transmit via nursing. Quick and early diagnosis of the HIV-infected infant is needed and possible by using rapid HIV-1&2 diagnostic test kit designed by JN-International, Inc., permitting timely and effective treatment. Advances in antiretroviral therapy, specifically the development of highly active anti-retrovirals (HAART), including combination therapies of nucleoside analogues and protease inhibitors, are also now available for children. Furthermore, more effective measures of virus burden, specially the advent of HIV RNA polymerase chain reaction (PCR) and its prognostic value for determining subsequent disease development, has changed the clinical management of HIV disease. However, this assay is time consuming and expensive, not practical for screening large number of population in the given time. Where as, rapid HIV test is advantageous for quicker screening of large population and for implementation of effective measures.
18 Point of care testing (POCT) Shift from central lab testing to other sites in the last decadeDiabetes monitoringFertility testingKidney and liver functionTumor detectionInfectious diseaseAlcoholoism
19 POCT Sites POL Pharmacies Wards Emergency Room Intensive Care Respiratory CareHealth ScreeningLong term careNursing HomeHomecare
20 Point of Care Testing (POCT) 1997 WW SALES SHARE TOP VOLUME RAPID TESTS($1-2 BB This Decade)From: The Market for Rapid InVitro Diagnostic Tests, Find/SVP, 1998
21 JN-International Medical Corporation COMPANY: JN-International Medical Corporation is an emerging biotechnology company engaged in development and distribution of Medical Diagnostics and Vaccines for World health care and management of diseases & disorders. The primary business objective of the corporation is participation in International Tenders for the supply of Diagnostics and Vaccines. DIAGNOSTICS: JN offers over 290 diagnostic products; supplying a full range of commonly used test kits from a single source. JN's rapid tests include cardiac markers, cancer markers, sexually transmitted disease tests and infectious disease tests. JN is leading the way. In addition, our products are also used in several international epidemiological studies. JN plans to expand its product offerings and information services through its international distribution network system and the best experience for Healthcare professionals on a worldwide basis. JN products incorporate modern technology in open flexible formats that utilize genetically engineered techniques to diagnose infectious diseases and various sexually transmitted diseases, and are also used in the areas of reproductive health, viral and bacterial infectious diseases, gastrointestinal, hormones, cancer, cardiac, auto-immune disorders and for therapeutic drug treatment and drug abuse testing.JN-International Medical Corporation, P.O. Box 35,Oakland, NE 68045, USA, Tel , ,Fax , Omaha, NE 68122, Web site: