qualtex whole blood testing

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Your Partner for Whole Blood Donor Screening

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QualTex Whole Blood Testing brochure

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Page 1: QualTex Whole Blood Testing

Your Partner for Whole Blood Donor Screening

6211 IH 10 West, San Antonio, Texas 78201 A 4258 Communication Drive, Norcross, Georgia 30093

www.qualtexlabs.org

(888) QTX-LABS

QualTex focuses on serving as your partner for whole blood testing by supporting

your mission, and leaving you secure in your relationships with your hospital clients.

Our blood bank affiliate, the South Texas Blood & Tissue Center, seeks regional contracts,

rather than competing on a national level or in your markets for blood donors or clients.

Because you need a partner that brings a variety of advantages to the table, QualTex is

part of an enterprise that includes the Texas Cord Blood Bank and GenCure regenerative

medicine services. We can bring you partnerships that allow collaboration in related

high-tech industries, without the threat of competition for your core business.

At QualTex, Testing Is Our Business

Page 2: QualTex Whole Blood Testing

Two Locations Provide Redundant Large-Volume Capacity

To provide the capacity and logistical efficiency

to ensure timely deliveries of your test results,

QualTex Laboratories operates at two locations

in the U.S., in Norcross (Atlanta), Georgia, and

San Antonio, Texas. Each facility maintains an

operational capacity of more than 8 million

samples. Our infrastructure is configured

for high-volume sample testing with robust

processes for sample receipt, processing,

testing and delivering results.

QualTex facilities are strategically configured

to serve as a backup testing facility for each

location. The laboratories at QualTex operate 24

hours a day, 7 days a week, 365 days a year,

allowing us to provide timely test results that

exceed industry standards.

Our Specialty In Large-Volume Testing Translates Into Competitive Pricing

As the current economic environment leads

more blood banks to transfer whole blood

testing to third-party labs, our large-volume

capacity provides economies of scale that

cannot be matched in smaller labs.

Our position as the largest independent testing

lab in the U.S. for donor screening, testing more

than 8 million samples every year for clients

around the world, translates into economic

advantages that can maximize your budget. See

how our combination of competitive pricing,

large-volume expertise, long experience in

the blood bank industry and commitment to

customer service makes us the partner of

choice to support your mission to save lives and

support public safety.

QualTex Has the Technology to Exceed Testing Accuracy Standards

Our commitment to quality is backed up by

an investment in testing platforms that ensure we

exceed accuracy standards. Our platforms deliver

the lowest false-positive rate in the industry,

increasing the number of healthy donor samples.

Our fully automated platforms also maximize

operational efficiencies that are critical in dealing

with high volumes of donor samples.

QualTex offers a comprehensive package of testing platforms and assays:

Abbott PRISM – Used for Anti-HIV, Anti-HCV, Anti HTLV I/II,

Anti-HBc, HBsAg, Anti-T. cruzi (Chagas) and HBsAg

Neutralization. This technology offers the lowest

false-positive rate in the industry.

NOVARTIS Tigris – Used to perform NAT testing for HIV,

HCV & HBV (Ultrio) and West Nile Virus. All testing can

be performed in pools of 16 or in singlet.

Beckman Coulter PK 7300 – Used for ABO/Rh,

Red Cell Phenotyping, STS and CMV testing.

Immucor Gamma NEO – Used to perform atypical antibody screening on all donor samples.

Testing Accuracy Is Our PriorityIn whole blood screening, testing accuracy is paramount — providing

both a safety net to protect public health and a strategy to ensure

the highest possible number of healthy donor samples.

QualTex Laboratories is an internationally recognized facility that is

FDA and ISO registered, CLIA certified, and approved or accredited

by multiple companies and health ministries worldwide. We’ve made

continuous improvement a core value, developing processes that

achieve and sustain performance excellence by incorporating input

from employees, clients and regulatory audits.

Our employees are invested in providing the quality results required to surpass testing accuracy

standards. With more than 35 years of experience in whole blood testing, our commitment to quality at

every step along the way gives you the confidence in your testing results that is critical to your mission

of saving lives.

The Registrations/The Registrations/The Registrations/Certifications QualTex Certifications QualTex Certifications QualTex

Maintains IncludeMaintains IncludeMaintains Include(Complete List Online)(Complete List Online)(Complete List Online)(Complete List Online)(Complete List Online)(Complete List Online)

FDA Registration San Antonio

#3006339676

FDA Registration Norcross

#3008670156

CLIA San Antonio

#45D0500519

CLIA Norcross

#11D2016499

BLOOD TESTING SERVICES:

A Anti-HIV

A Anti-HCV

A Anti-HTLV I/II

A Anti-HBc

A HBsAg

A Syphilis

A Anti-T. cruzi (Chagas)

A Anti-CMV

A HIV/HCV/HBV NAT

A West Nile Virus NAT

A Parvo B19 NAT

A HAV NAT

A ABO/Rh

A Antibody Screen

A Confirmatory:HIV-1 Western Blot

HIV-2 EIA

HCV RIBA

Syphilis confirmatory

HBsAg Neutralization

A Supplemental:Chagas

A Component Manufacturing QC:Residual WBC count

Factor VIII and Fibrinogen

Platelet Count

Hemoglobin (Hgb)

Hematocrit (H&H)

A Immunohematology:RBC Genotyping

HLA Phenotyping(Class I A/B) for TRALI mitigation

HLA Antibody Screen

Platelet Specific Antibody Screen

Neutrophil Antibody Screen

Alternate HTLV I/II

A Optional Testing:Cholesterol

High Density Lipoprotein (HDL)

Low-Density Lipoprotein (LDL)

Triglyceride

Please see website for complete list of services. qualtexlabs.org

Specialized Customer Service Solutions

As your partner for whole blood testing, QualTex specializes in customized, competitive testing

solutions based on your unique needs and requirements. With more than 35 years of whole blood

testing experience and roots in the blood bank industry, we understand your priorities.

QualTex delivers the rapid turnaround times critical to maximizing the short lifespan of whole blood

products. Routine turnaround time is 10 – 12 hours from receipt of test samples. Customer service

support teams are available 7 days a week, offering logistics and transport services to meet your deadlines.

Samples are shipped via private courier for

counter-to-counter transport, with validated

shipping containers provided at no addi-

tional cost. Results are delivered by a 510K-

approved system, electronic file transfer

(FTP site), via email (PDF), or FAX.

Page 3: QualTex Whole Blood Testing

Two Locations Provide Redundant Large-Volume Capacity

To provide the capacity and logistical efficiency

to ensure timely deliveries of your test results,

QualTex Laboratories operates at two locations

in the U.S., in Norcross (Atlanta), Georgia, and

San Antonio, Texas. Each facility maintains an

operational capacity of more than 8 million

samples. Our infrastructure is configured

for high-volume sample testing with robust

processes for sample receipt, processing,

testing and delivering results.

QualTex facilities are strategically configured

to serve as a backup testing facility for each

location. The laboratories at QualTex operate 24

hours a day, 7 days a week, 365 days a year,

allowing us to provide timely test results that

exceed industry standards.

Our Specialty In Large-Volume Testing Translates Into Competitive Pricing

As the current economic environment leads

more blood banks to transfer whole blood

testing to third-party labs, our large-volume

capacity provides economies of scale that

cannot be matched in smaller labs.

Our position as the largest independent testing

lab in the U.S. for donor screening, testing more

than 8 million samples every year for clients

around the world, translates into economic

advantages that can maximize your budget. See

how our combination of competitive pricing,

large-volume expertise, long experience in

the blood bank industry and commitment to

customer service makes us the partner of

choice to support your mission to save lives and

support public safety.

QualTex Has the Technology to Exceed Testing Accuracy Standards

Our commitment to quality is backed up by

an investment in testing platforms that ensure we

exceed accuracy standards. Our platforms deliver

the lowest false-positive rate in the industry,

increasing the number of healthy donor samples.

Our fully automated platforms also maximize

operational efficiencies that are critical in dealing

with high volumes of donor samples.

QualTex offers a comprehensive package of testing platforms and assays:

Abbott PRISM – Used for Anti-HIV, Anti-HCV, Anti HTLV I/II,

Anti-HBc, HBsAg, Anti-T. cruzi (Chagas) and HBsAg

Neutralization. This technology offers the lowest

false-positive rate in the industry.

NOVARTIS Tigris – Used to perform NAT testing for HIV,

HCV & HBV (Ultrio) and West Nile Virus. All testing can

be performed in pools of 16 or in singlet.

Beckman Coulter PK 7300 – Used for ABO/Rh,

Red Cell Phenotyping, STS and CMV testing.

Immucor Gamma NEO – Used to perform atypical antibody screening on all donor samples.

Testing Accuracy Is Our PriorityIn whole blood screening, testing accuracy is paramount — providing

both a safety net to protect public health and a strategy to ensure

the highest possible number of healthy donor samples.

QualTex Laboratories is an internationally recognized facility that is

FDA and ISO registered, CLIA certified, and approved or accredited

by multiple companies and health ministries worldwide. We’ve made

continuous improvement a core value, developing processes that

achieve and sustain performance excellence by incorporating input

from employees, clients and regulatory audits.

Our employees are invested in providing the quality results required to surpass testing accuracy

standards. With more than 35 years of experience in whole blood testing, our commitment to quality at

every step along the way gives you the confidence in your testing results that is critical to your mission

of saving lives.

FDA Registration San Antonio

#3006339676

FDA Registration Norcross

#3008670156

CLIA San Antonio

#45D0500519

CLIA Norcross

#11D2016499

BLOOD TESTING SERVICES:

A Anti-HIV

A Anti-HCV

A Anti-HTLV I/II

A Anti-HBc

A HBsAg

A Syphilis

A Anti-T. cruzi (Chagas)

A Anti-CMV

A HIV/HCV/HBV NAT

A West Nile Virus NAT

A Parvo B19 NAT

A HAV NAT

A ABO/Rh

A Antibody Screen

A Confirmatory:HIV-1 Western Blot

HIV-2 EIA

HCV RIBA

Syphilis confirmatory

HBsAg Neutralization

A Supplemental:Chagas

A Component Manufacturing QC:Residual WBC count

Factor VIII and Fibrinogen

Platelet Count

Hemoglobin (Hgb)

Hematocrit (H&H)

A Immunohematology:RBC Genotyping

HLA Phenotyping(Class I A/B) for TRALI mitigation

HLA Antibody Screen

Platelet Specific Antibody Screen

Neutrophil Antibody Screen

Alternate HTLV I/II

A Optional Testing:Cholesterol

High Density Lipoprotein (HDL)

Low-Density Lipoprotein (LDL)

Triglyceride

Please see website for complete list of services. qualtexlabs.org

Specialized Customer Service Solutions

As your partner for whole blood testing, QualTex specializes in customized, competitive testing

solutions based on your unique needs and requirements. With more than 35 years of whole blood

testing experience and roots in the blood bank industry, we understand your priorities.

QualTex delivers the rapid turnaround times critical to maximizing the short lifespan of whole blood

products. Routine turnaround time is 10 – 12 hours from receipt of test samples. Customer service

support teams are available 7 days a week, offering logistics and transport services to meet your deadlines.

Samples are shipped via private courier for

counter-to-counter transport, with validated

shipping containers provided at no addi-

tional cost. Results are delivered by a 510K-

approved system, electronic file transfer

(FTP site), via email (PDF), or FAX.

Page 4: QualTex Whole Blood Testing

Two Locations Provide Redundant Large-Volume Capacity

To provide the capacity and logistical efficiency

to ensure timely deliveries of your test results,

QualTex Laboratories operates at two locations

in the U.S., in Norcross (Atlanta), Georgia, and

San Antonio, Texas. Each facility maintains an

operational capacity of more than 8 million

samples. Our infrastructure is configured

for high-volume sample testing with robust

processes for sample receipt, processing,

testing and delivering results.

QualTex facilities are strategically configured

to serve as a backup testing facility for each

location. The laboratories at QualTex operate 24

hours a day, 7 days a week, 365 days a year,

allowing us to provide timely test results that

exceed industry standards.

Our Specialty In Large-Volume Testing Translates Into Competitive Pricing

As the current economic environment leads

more blood banks to transfer whole blood

testing to third-party labs, our large-volume

capacity provides economies of scale that

cannot be matched in smaller labs.

Our position as the largest independent testing

lab in the U.S. for donor screening, testing more

than 8 million samples every year for clients

around the world, translates into economic

advantages that can maximize your budget. See

how our combination of competitive pricing,

large-volume expertise, long experience in

the blood bank industry and commitment to

customer service makes us the partner of

choice to support your mission to save lives and

support public safety.

QualTex Has the Technology to Exceed Testing Accuracy Standards

Our commitment to quality is backed up by

an investment in testing platforms that ensure we

exceed accuracy standards. Our platforms deliver

the lowest false-positive rate in the industry,

increasing the number of healthy donor samples.

Our fully automated platforms also maximize

operational efficiencies that are critical in dealing

with high volumes of donor samples.

QualTex offers a comprehensive package of testing platforms and assays:

Abbott PRISM – Used for Anti-HIV, Anti-HCV, Anti HTLV I/II,

Anti-HBc, HBsAg, Anti-T. cruzi (Chagas) and HBsAg

Neutralization. This technology offers the lowest

false-positive rate in the industry.

NOVARTIS Tigris – Used to perform NAT testing for HIV,

HCV & HBV (Ultrio) and West Nile Virus. All testing can

be performed in pools of 16 or in singlet.

Beckman Coulter PK 7300 – Used for ABO/Rh,

Red Cell Phenotyping, STS and CMV testing.

Immucor Gamma NEO – Used to perform atypical antibody screening on all donor samples.

Testing Accuracy Is Our PriorityIn whole blood screening, testing accuracy is paramount — providing

both a safety net to protect public health and a strategy to ensure

the highest possible number of healthy donor samples.

QualTex Laboratories is an internationally recognized facility that is

FDA and ISO registered, CLIA certified, and approved or accredited

by multiple companies and health ministries worldwide. We’ve made

continuous improvement a core value, developing processes that

achieve and sustain performance excellence by incorporating input

from employees, clients and regulatory audits.

Our employees are invested in providing the quality results required to surpass testing accuracy

standards. With more than 35 years of experience in whole blood testing, our commitment to quality at

every step along the way gives you the confidence in your testing results that is critical to your mission

of saving lives.

FDA Registration San Antonio

#3006339676

FDA Registration Norcross

#3008670156

CLIA San Antonio

#45D0500519

CLIA Norcross

#11D2016499

BLOOD TESTING SERVICES:

A Anti-HIV

A Anti-HCV

A Anti-HTLV I/II

A Anti-HBc

A HBsAg

A Syphilis

A Anti-T. cruzi (Chagas)

A Anti-CMV

A HIV/HCV/HBV NAT

A West Nile Virus NAT

A Parvo B19 NAT

A HAV NAT

A ABO/Rh

A Antibody Screen

A Confirmatory:HIV-1 Western Blot

HIV-2 EIA

HCV RIBA

Syphilis confirmatory

HBsAg Neutralization

A Supplemental:Chagas

A Component Manufacturing QC:Residual WBC count

Factor VIII and Fibrinogen

Platelet Count

Hemoglobin (Hgb)

Hematocrit (H&H)

A Immunohematology:RBC Genotyping

HLA Phenotyping(Class I A/B) for TRALI mitigation

HLA Antibody Screen

Platelet Specific Antibody Screen

Neutrophil Antibody Screen

Alternate HTLV I/II

A Optional Testing:Cholesterol

High Density Lipoprotein (HDL)

Low-Density Lipoprotein (LDL)

Triglyceride

Please see website for complete list of services. qualtexlabs.org

Specialized Customer Service Solutions

As your partner for whole blood testing, QualTex specializes in customized, competitive testing

solutions based on your unique needs and requirements. With more than 35 years of whole blood

testing experience and roots in the blood bank industry, we understand your priorities.

QualTex delivers the rapid turnaround times critical to maximizing the short lifespan of whole blood

products. Routine turnaround time is 10 – 12 hours from receipt of test samples. Customer service

support teams are available 7 days a week, offering logistics and transport services to meet your deadlines.

Samples are shipped via private courier for

counter-to-counter transport, with validated

shipping containers provided at no addi-

tional cost. Results are delivered by a 510K-

approved system, electronic file transfer

(FTP site), via email (PDF), or FAX.

Page 5: QualTex Whole Blood Testing

Your Partner for Whole Blood Donor Screening

6211 IH 10 West, San Antonio, Texas 78201 A 4258 Communication Drive, Norcross, Georgia 30093

www.qualtexlabs.org

(888) QTX-LABS

QualTex focuses on serving as your partner for whole blood testing by supporting

your mission, and leaving you secure in your relationships with your hospital clients.

Our blood bank affiliate, the South Texas Blood & Tissue Center, seeks regional contracts,

rather than competing on a national level or in your markets for blood donors or clients.

Because you need a partner that brings a variety of advantages to the table, QualTex is

part of an enterprise that includes the Texas Cord Blood Bank and GenCure regenerative

medicine services. We can bring you partnerships that allow collaboration in related

high-tech industries, without the threat of competition for your core business.

At QualTex, Testing Is Our Business

Page 6: QualTex Whole Blood Testing

Your Partner for Whole Blood Donor Screening

6211 IH 10 West, San Antonio, Texas 78201 A 4258 Communication Drive, Norcross, Georgia 30093

www.qualtexlabs.org

(888) QTX-LABS

QualTex focuses on serving as your partner for whole blood testing by supporting

your mission, and leaving you secure in your relationships with your hospital clients.

Our blood bank affiliate, the South Texas Blood & Tissue Center, seeks regional contracts,

rather than competing on a national level or in your markets for blood donors or clients.

Because you need a partner that brings a variety of advantages to the table, QualTex is

part of an enterprise that includes the Texas Cord Blood Bank and GenCure regenerative

medicine services. We can bring you partnerships that allow collaboration in related

high-tech industries, without the threat of competition for your core business.

At QualTex, Testing Is Our Business