apresentação prime - inglÊs - programa de triagem (10) alteraÇÕes1.ppt (1.103)

Prime Diagnostics

Screening Program

Our commitment to being recognized as the most innovating, quality and consumer-

oriented distribution company of in vitro diagnostics products of Brazilian and

international markets, leads us to a strategy that includes the approval of ANVISA¹ on all

equipment and products offered to the market by Prime Diagnostics.

Our suppliers have the main international certifications (ISO9001, ISO13485, GMP-Good

Manufacturing Practices, etc.), fact that allows us to satisfy completely, or even exceed,

the requirements of the market.

(1) - ANVISA – Agência Nacional de Vigilância Sanitária (Vinculada ao Ministério da Saúde) (National Health Surveillance Agency (linked to the Ministry of Health)

Mission

21

● General Population Screening Tests ● Hepatitis B ● Hepatitis C ● Syphilis ● HIV

Our Business

Human blood samples collected on

filter paper S&S 903

● Concept: Screening of large populations;

● Objective: 100% of the entire population;

● Methodology: Sample of dried blood collected on paper filter (ELISA).

Business Philosophy

Aiming at:Facilitating access to patientsIdentifying epidemiological profile

Procedure for collecting blood on paper filter

See attached sample

Access Practicality Prevention Innovation Economy

Benefits

Access Practicality Prevention Innovation Economic

• Internalization of the Epidemic

• Limited need of laboratory infrastructure in remote areas• Paper filter takes the laboratory structure of urban centers that are difficult to access.

Benefits

• Easy method of sample collection -Total blood•Great solid support for antibodies•Low volume and little invasive •(50ul/spot)

•Transport (non-infectious)• Easy storage at room temperature• great stability

Access Practicality Prevention Innovation Economic

Benefits

Access Practicality Prevention Innovation Economic

•Facilitates the diagnosis and consequently:

• Immediate treatment and reduction of severe cases• Increasing opportunities of prevention • Decrease in costs with assistance

Benefits

Access Practicality Prevention Innovation Economic

• This methodology can be integrated:

•Urban, rural and remote population

•Family health program

Benefits

Benefits

Access Practicality Prevention Innovation Economy

• Cost SavingsTransportationStorageEquipment

Material- Syringe needle-Collection tubes- Energy (no spin)

Logistics Serum Paper Filter

Extraction Syringe Lancet

Preparation Centrifugal machine -

Conservation Controlled Temperature(Ice)

Environment

TransportationPolystyrene

(Ice) Envelope

Professional Professionals Simple Training

The Benefits of Paper Filter vs. the Serum Method

1. Samples of dried blood on filter paper are easy to collect, carry and store.

2. Results equivalent to those obtained using the alternative method of test on serum.

3. Excellent solution for areas without structure, or with precarious laboratory structure.

4. Studies conducted by Brazilian institutions showed that, unlike the collection method on needles, dried blood samples on paper filter remain keep their properties preserved at extreme temperature conditions as 51°C, even when combined with high humidity.

Summary

HIV infection in the population is a growing

problem, especially in developing countries

hit by the AIDS epidemic.

The most frequent way of a child to

acquire HIV infection is through his/her

mother during pregnancy, at birth or

through breastfeeding.

The Importance of Prevention

In the 21st century, the HIV epidemic continues out

of control in many countries of the world. The Joint

United Nations Program on HIV/AIDS (UNAIDS)

estimates that 40 million people would be living with

HIV/AIDS, five million are infected every year, of

which three million would be children; of these, 500

thousand children would die as a result of the

infection and 700 thousand would have acquired

new infections only that year, many of them taken to

death before reaching adolescence.

The Importance of Prevention

Whatever the disease, it is always better to identify it in the pre-

symptomatic phase or in its early stages. This is the reason why the

programs aimed at the prevention and early diagnosis of various

diseases are the main objectives of current health initiatives. The main

purpose of these educational and prevention initiatives is to provide all

the resources necessary to disclose the information required for the

reduction of infection and mortality rates.

For example, the treatment of syphilis, a disease that can cause

blindness or death in neonates, can be accomplished with a single dose

of Benzathine Penicillin in primary cases, or up to 3 doses (one per

week), in cases of secondary or latent syphilis.

The Importance of Prevention

These initiatives can be applied to:

• General Screening Programs: For men and women in screening

diseases, such as AIDS, Syphilis and Hepatitis B and C.

The Importance of Prevention

The importance of diagnostic tests for the detection of infectious diseases,

has been widely disclosed around the world.

Programs with this scope of coverage, given their magnitude, only would be

possible to be implemented with the use of paper filter for the collection of

samples.

The Importance of Prevention

Infectious Disease Screening Program for the Population

What Prime Provides:

Prime Diagnostics has been operating in

the Brazilian market for more than five

years, and has extensive knowledge and

experience in the implementation,

management and control of population

screening programs intended for the

detection of infectious diseases.

Infectious Disease Screening Program

What Prime Provides:

1-Automated and/or semi-automated equipment:

High-tech equipment for the processing of results properly

certified at the major world sanitation control agencies such as the FDA and CE.

All equipment will be transferred under the lending scheme (commodato), without additional cost to the program.

2 - Technical Assistance for the maintenance and repair of equipment.

Alternatives to

1 - Automated and/or semi-automated equipment:

2 – Technical Assistance

Alternative consists of hiring a laboratory to conduct the tests and the same will be paid by PRIME.

Infectious Disease Screening Program for the Population

What Prime Provides: 4- Collection kit All the material necessary to the collection of blood samples (model attached).1 - Lancet 2- Sachet Silica3- Sachet Alcohol 4– Paper filter 5– Collecting card 6- Manual 7- Small envelope 8- Larger envelope

Infectious Disease Screening Program for the Population

• 5 - Operational Training of Sample Collection:

Training of multipliers of the process in relation to the care and use of the material provided for the collection, storage, handling and transport of samples.

Infectious Disease Screening Program for the Population

What Prime Provides:

6 – Chemical and Biological Reagents: Reagents needed for the processing of samples, tested and approved by international agencies of sanitary control.

What Prime Provides:

7 - Web-based management program:

Program for remote access to web-based results, with access protected by individual

password. (model attached)

Login l (lowercase L) 970

Password: bio970

Infectious Disease Screening Program for the Population

See example attached

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

RECORDS AT ANVISA

APPROVAL IN SOUTH AFRICA

APPROVAL IN SOUTH AFRICA

APPROVAL IN SOUTH AFRICA

APPROVAL IN SOUTH AFRICA