apresentação prime 092009_ing

Prime Diagnostics of Brazil

Our commitment to be recognized as the most innovative, quality and

customer service oriented IVD Distributor Company in the Brazilian market, has

led us to a strategy that involves the ANVISA1 approval for all products and

equipments offered by Prime Diagnostics. Also all our suppliers are certified by

the main International Quality Management Systems (ISO9001, ISO13485, GMP -the main International Quality Management Systems (ISO9001, ISO13485, GMP -

Good Manufacturing Practices, etc .) which allows us to completely satisfy, and

even surpass, all market requirements.

(1) - ANVISA – National Agency of Sanitary Surveillance (linked to Brazilian Ministry of Health)

Infectious Diseases Screening Tests

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● Prenatal Screening Tests

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● General Screening Tests

● History and the success of Newborn Screening

● 2002: Researchers and specialists developed the Q-Preven product line,kits which used samples of human blood collected on S&S903 filter

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kits which used samples of human blood collected on S&S903 filterpaper for infectious diseases screening.

1960, Robert Guthrie (1916- 1995)

Buffalo, NY

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Background

Guthrie published on 1963 theresults of a study involving400.000 newborn samples in thespecialized magazine Pediatrics(Guthrie R, Susi A. A Simple

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(Guthrie R, Susi A. A SimplePhenylalanine Method forDetecting Phenylketonuria inLarge Populations of NewbornInfants. Pediatrics, 1963 Sep;32:318-343).

Filter Paper in Brazil

1968 – Adopted by WHO/OMS (World Health Organization);

1976 – Introduced in Brazil

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1976 – Introduced in Brazil

1992 – Mandatory throughout the entire Brazilian territory

2001 – Newborn Screening National Program

SCREENING Definition

Preventive care and educational initiatives for pregnant women, general population and newborn babies.

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babies.

SCREENINGKit to collect samples

- Lancet

- Card (Filter Paper)

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● Concept: Screening for the masses;

● Target: 100% of all population;

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SCREENINGPhilosophy

● Target: 100% of all population;

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

● Facilitate the access to patients

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SCREENINGObjectives

● Identify the epidemiological profile.

Sample Collecting Procedure for Filter Paper

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Punching the dried blood spot samples to ELISA Microplate

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Dried blood spot

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Dilute the samplesPRIME Branded products

Sample Shaking and DilutionPRIME Branded products

Pipetting the Diluted Samples

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Equipments• Semi-Automatic

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ELISA microplates Reader

Equipments• Semi – Automatic

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ELISA Microplate Washer

Equipments• Fully Automatic

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Equipments• Puncher

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Access Practical Prevention Innovation Economical

AdvantagesPRIME Branded products

Access Prevention Innovation Economical

AdvantagesPractical

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• Rural epidemic control

• Laboratory infrastructure in remote areas

• Filter paper brings the laboratory structure from urbanized cities to the most remote places

Access Practical Prevention Innovation Economical

AdvantagesPRIME Branded products

• Easy method to collect the samples- Whole blood• Excellent solid support for antibodies• Low volume and non-invasive

(50ul/spot)•Transport (not infectious)• Room temperature facilitates storage

procedures• Excellent stability

Access Practical Prevention Innovation Economical

AdvantagesPRIME Branded products

• Easy to diagnose

• Immediate treatment, decreasing the number of critical cases

• Prevention Opportunities increase

• Lower Health Care costs

Access practicable Prevention Innovation Economical

AdvantagesPRIME Branded products

• This methodology can be integratedto preexisting programs:

• Rural and Indigen Population , etc...

• Family Health Programs

• Health Agents Programs

AdvantagesAccess practicable Prevention Innovation Economical

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• Cost Savings:TransportStorageEquipment

Materials:- Syringe / needle- Tubes (to collect samples)- Energy (no centrifuging procedure)

Summary1. Dried samples in filter paper are easy to

collect, transport and store.

2. Equivalent results when compared to the

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2. Equivalent results when compared to the

alternative liquid method.

3. Excellent solution for areas with no or minimal

laboratory infrastructure

SCREENINGAdvantages related to the use of filter paper

LOGISTCS Serum Filter Paper

EXTRACTION Syringe Lancet

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PREPARATION Centrifuge -

CONSERVATION Controled Temperature(Ice)

Ambient

SHIPMENT Styrofoam(Ice)

Envelop

PROFESSIONAL Specialized Simple Training

SCREENINGCONVENTIONAL ELISA MODIFIED ELISA

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SampleSerum/Plasma

SampleFilter Paper

SCREENING

HIVSyphilis

Infectious Diseases Kits in Filter Paper

CHAGASHTLV

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SyphilisTOXOMEASLESCMV

HTLVHCVHEPATITIS B

PRENATAL SCREENING

“It is terrible when a child dies due to AIDS.

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“It is terrible when a child dies due to AIDS.However it is worst when we know that it couldhave been prevented.”PEDIATRIC AIDS FOUNDATION