Transcript Document

JN-International Medical Corporation
HIV RAPID IMMUNO DIAGOSTIC TEST KIT
JN-International, Inc.
Product Capabilities; Lateral Flow
Test
Line
Sample
Control
Line
Conjugate
Negative Result
Positive Result
Wick
JN-International, Inc.
HIV Two-Line Test
HIV-1/HIV-2
Sample
Control
Conjugate
Negative Result
Positive Result
Wick
JN-International, Inc.
HIV TRI-LINE
HIV-2 HIV-1
Control
Sample
Conjugate
Negative Result
Positive Result
Wick
JN-QC-SPOT Rapid Tests
Share of Market for Rapid Diagnostic Tests, by Product Segment: 1998.
2%
2%
6%
4%
22%
7%
8%
18%
13%
18%
Source: Kalorama Information, LLC, January, 1999.
Infectious Diseases
Drugs of Abuse
Therapeutic Drug Monitoring
Cardiac Markers
Portable Blood Analyzers
Pregnancy
Diabetes
Cholesterol Monitoring
Cancer
Other
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 AJ and ‘O’ in plasma, serum, and whole blood.
JN-QC-SPOT Rapid HIV Test
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Hospitals
Laboratories
Medical Clinics
Physicians' offices
Emergency care situations where standard tests
are not practical or available
JN-QC-SPOT Rapid HIV Test
Product Goals
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The ability to detect HIV-1 antibodies
The ability to detect HIV-2 antibodies
The ability to detect HIV-1, group O antibodies
Sensitivity and specificity of 98-100%
Simple and quick
JN-QC-SPOT Rapid HIV Test
• Sensitivity – The ability to detect positive
samples
• Specificity – The ability to distinguish between
positive and negative samples
JN-QC-SPOT Rapid HIV Test
Development History
•Development Project began April 1996
•Configuration– November 1996
•HIV Whole Blood Format Prototype
completed – September 1997
•Whole Blood Format – February 1998
•Combined Serum/plasma and Whole Blood
Format – July 1998
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 1998
– Caribbean Epidemiology Center, Pan American Health
Organization, World Health Organization (WHO),
Port of Spain, Trinidad
• Third Evaluation by– February 1999
– Kenya Medical Research Institute, WHO East and Central
Africa Reference Laboratory, Nairobi, Kenya
- CONTINUED
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. Africa
•Fifth Evaluation by – September, 2000
- Centro Colaborador Para El Sida (CNRS)
World Health Organization,
Buenos Aires, Argentina
•Sixth Evaluation by – July, 2002
- National AIDS Reference Laboratories (NARL)
Infectious Diseases Research Centre (IDRC)
Institute of Medical Research
Kuala Lumpur, Malaysia
JN-QC-SPOT Rapid HIV Test
Performing the Assay
JN-QC-SPOT Rapid HIV Test
Performing the Assay
Results after 15 minutes
JN-QC-SPOT Rapid HIV Test
Field Evaluations and Results
Date
Total No. of
Samples
Samples
Sensitivity
Specificity
Caribbean Epidemiology Center
Serum /
World Health Organization
Plasma
(WHO)
Oct. 1998
289
HIV-1 and
HIV-2
98%
100%
Vanderbuilt Medical Center
Serum /
Plasma
Apr. 1997
2000
HIV-1 and
HIV-2
99.5
99.90%
KMRI / World Health
Organization
Serum /
Plasma
April/May
1999
387
HIV-1 and
HIV-2
96.80%
100.00%
KING/DREW MEDICAL CENTER
Whole
Blood
Jan. 1999
35
HIV-1 and
HIV-2
100%
100%
National Institute of Virology,
Sandringham, South Africa
Serum /
Plasma
Feb. 2000
150
HIV-1 and
HIV-2
100%
100%
CNRS/ WHO
Serum /
Plasma
Sep. 2000
181
HIV-1 and
HIV-2
100%
100%
NARL/ IDRC/ IMR
Serum
Jul-02
50
HIV-1 and
HIV-2
100%
100%
Testing Facility
Format
JN-QC-SPOT Rapid HIV Test
2001 Goals
• Complete Validation Process
• Continue with overall GMP Requirements for UK,
India and Belgium
• Submit clinical protocols to investigative sites
• Begin clinical studies and collect data in Africa, S.Asia
and S.America.
• Analyze and summarize data
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 multifactorial 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 JNInternational, 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.
Point of care testing (POCT)
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Shift from central lab testing to other sites in the last decade
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Diabetes monitoring
Fertility testing
Kidney and liver function
Tumor detection
Infectious disease
Alcoholoism
POCT Sites
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Pharmacies
Wards
Emergency Room
Intensive Care
Respiratory Care
Health Screening
Long term care
Nursing Home
Homecare
Point of Care Testing (POCT)
1997 WW SALES SHARE TOP VOLUME RAPID TESTS
($1-2 BB This Decade)
OTHER (6.00%)
STREPTOCOCCUS (6.00%)
STD'S, UTI, VAGINAL (9.00%)
DRUGS OF ABUSE (24.00%)
H. PY LORI (9.00%)
CARDIAC MARKER (10.00%)
PREGNACY (24.00%)
HIV (12.00%)
From: The Market for Rapid InVitro Diagnostic Tests, Find/SVP, 1998
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, autoimmune disorders and for therapeutic drug treatment and drug abuse testing.
JN-International Medical Corporation, P.O. Box 35,Oakland, NE 68045, USA,
Tel. 402-685-6587, 402-685-6591,Fax. 402-614-4437, Omaha, NE 68122, Web site:
http://www.jnii-usa-bharat.com
E-mail: [email protected]