JN-International Medical Corporation

HIV RAPID IMMUNO DIAGOSTIC TEST KIT

JN-International, Inc.Product Capabilities; Lateral Flow

Sample

WickTestLine

Conjugate

ControlLine

Negative Result

Positive Result

JN-International, Inc.HIV Two-Line Test

Sample

WickHIV-1/HIV-2

Conjugate

Control

Negative Result

Positive Result

JN-International, Inc.HIV TRI-LINE

Sample

WickHIV-2

Conjugate

Control

Negative Result

Positive Result

HIV-1

JN-QC-SPOT Rapid Tests

Source: Kalorama Information, LLC, January, 1999.

22%

18%

18%13%

8%

7%6% 4%

2%

2% Infectious Diseases

Drugs of Abuse

Therapeutic Drug Monitoring

Cardiac Markers

Portable Blood Analyzers

Pregnancy

Diabetes

Cholesterol Monitoring

Cancer

Other

Share of Market for Rapid Diagnostic Tests, by Product Segment: 1998.

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.

JN-QC-SPOT Rapid HIV Test

• Hospitals• Laboratories• Medical Clinics• Physicians' offices• Emergency care situations where standard tests

are not practical or available

JN-QC-SPOT Rapid HIV TestProduct Goals

• 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 TestDevelopment 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 TestPerforming the Assay

JN-QC-SPOT Rapid HIV TestPerforming the Assay

Results after 15 minutes

JN-QC-SPOT Rapid HIV TestField Evaluations and Results

Testing Facility Format DateTotal No. of

SamplesSamples Sensitivity Specificity

Caribbean Epidemiology Center World Health Organization

(WHO)

Serum / Plasma

Oct. 1998 289HIV-1 and

HIV-298% 100%

Vanderbuilt Medical CenterSerum / Plasma

Apr. 1997 2000HIV-1 and

HIV-299.5 99.90%

KMRI / World Health Organization

Serum / Plasma

April/May 1999

387HIV-1 and

HIV-296.80% 100.00%

KING/DREW MEDICAL CENTERWhole Blood

Jan. 1999 35HIV-1 and

HIV-2100% 100%

National Institute of Virology, Sandringham, South Africa

Serum / Plasma

Feb. 2000 150HIV-1 and

HIV-2100% 100%

CNRS/ WHOSerum / Plasma

Sep. 2000 181HIV-1 and

HIV-2100% 100%

NARL/ IDRC/ IMR Serum Jul-02 50HIV-1 and

HIV-2100% 100%

JN-QC-SPOT Rapid HIV Test2001 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 TestMother-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.

Point of care testing (POCT)

• Shift from central lab testing to other sites in the last decade

• Diabetes monitoring• Fertility testing• Kidney and liver function• Tumor detection• Infectious disease• Alcoholoism

POCT Sites

• POL• Pharmacies• Wards• Emergency Room• Intensive Care• Respiratory Care• Health Screening• Long term care• Nursing Home• Homecare

Point of Care Testing (POCT)

DRUGS OF ABUSE (24.00%)STD'S, UTI, VAGINAL (9.00%)

STREPTOCOCCUS (6.00%)OTHER (6.00%)

PREGNACY (24.00%)

H. PYLORI (9.00%)

CARDIAC MARKER (10.00%)

HIV (12.00%)

1997 WW SALES SHARE TOP VOLUME RAPID TESTS($1-2 BB This Decade)

From: The Market for Rapid InVitro Diagnostic Tests, Find/SVP, 1998

JN-International Medical CorporationCOMPANY:  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. 402-685-6587, 402-685-6591,Fax. 402-614-4437, Omaha, NE 68122, Web site: http://www.jnii-

usa-bharat.com E-mail: jninternational@msn.com