Apresentação prime 092009_ing
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Transcript of 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