We Reach the Highest Standards of Quality in PCR and qPCR Kit Development & Testing.

ProGene Diagnostix, a Division of ProGene Applied Sciences, uses a comprehensive QA/QC Management System designed to ensure:

• Regulation Compliance

Regulatory compliance is essential in successfully bringing new testing platforms to the marketplace. Our quality assurance and compliance efforts go beyond those required of a typical clinical laboratory (CLIA-88 and HIPAA):

• Independent Quality Assurance / Quality Control with dedicated auditing staff
• R & D trials project management and study coordination staff experienced in the demanding environment of trials testing and data management
• Quality system compliance training for needed laboratory staff
• Redundant, secure and safe archiving of study records
• Computerized system validation and security

• Sample Integrity

ProGene places great emphasis on proper storage of samples, precisely traceable handling to ensure that specimens are never contaminated, mislabeled, compromised or lost.

• Test Result Accuracy

Clients send specimens to ProGene for testing because they trust us to provide the most accurate results possible. In order to continue having that trust, we

• Use only the best available kits and methods from licensed reagent manufacturers as well as tests that ProGene has developed and validated through our rigorous standards
• Continually update our assays and processes to incorporate the latest discoveries and methodologies
• Employ only professional clinical, quality assurance, logistics, consulting and managerial staff
• Ensure that key employees are trained on and follow all applicable regulations, guidelines and standard operating procedures (SOPs)
• Encourage key staff members to pursue continuing education opportunities in their fields

• Data Integrity

To keep your confidential, proprietary test result data private and secure, ProGene:

• Hires experienced information technology professionals to manage data, networks and computer systems
• Employs sophisticated data backup, redundancy and security measures
• Implements secure data transfer protocols
• Validates information technology systems, software and processes

All kits listed below are made and validated in the U.S. They are for information, or research use only.

1- Qualitative PCR Kits:

1.1- HBV PCR Kit for Qualitative Detection of HBV:

Principle:

The HBV PCR kit is used to detect HBV based on the amplification of the specific DNA from the S gene of the HBV genome. The advantages of the kit are: (1) Effective total DNA extraction from sera with ProGene (PG) DNA extraction kit; (2) Use of PG primers to reach the highest sensitivity in the PCR; (3) Elimination of PCR carry-over with the built-in decontamination system in the PCR mix; (4) Inclusion of PG internal control in the PCR mix.

 Kit Content:

ONE HBV PCR Kit, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection of HBV

Detection Range:

Minimum Detection Limit                      100 copies/ml

 1.2- HCV PCR Kit for Qualitative Detection of HCV:

   Principle:

The HCV PCR kit is used to detect HCV in sera based on the amplification of the specific cDNA reverse transcripted from the 5’ region of the HCV genome. The advantages of the kit are: (1) Effective extraction of total RNA from the sera with ProGene (PG) RNA Extraction System; (2) Effective cDNA synthesis with PG cDNA Synthesis Kit; (3) Use of PG primers to reach the highest sensitivity in the PCR; (4) Elimination of PCR carry-over with the built-in decontamination system in the PCR Mix; (5) Inclusion of PG internal control in the PCR Mix.

  Kit Content:

ONE HCV PCR Kit, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection of HCV

  Detection Range:

  Minimum Detection Limit                      100 copies/ml

  1.3- HIV PCR Kit for Qualitative Detection of HIV:

   Principle:

The HIV PCR kit is used to detect HIV. It is based on the amplification of a specific cDNA that is reverse-transcripted from the HIV genome. The advantages of the kit are: (1) Highly effective extraction of total RNA from plasma with ProGene (PG) RNA Extraction System; (2) Highly effective cDNA synthesis with PG cDNA synthesis kit; (3) Use of PG primers to reach the highest sensitivity in the PCR; (4) No PCR carry-over with built-in decontamination in PG PCR Mix; (5) inhibitor control with PG PCR Mix.

  Kit Content:

ONE HIV PCR KIT, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection of HIV

Detection Range:

1.4- MTB PCR Kit for Qualitative Detection of MTB:

   Principle:

The MTB PCR kit is used to detect the M. tuberculosis (MTB) in different types of samples based on the amplification of the specific DNA around 250 bps from the IS 6110 of the M. tuberculosis genome. The advantages of the kit are: (1) Effective total DNA extraction from different types of samples with ProGene (PG) DNA extraction kit; (2) Use of PG primers to reach the highest sensitivity in PCR; (3) Elimination of the PCR carry-over with the built-in decontamination system in the PCR mix; (4) Inclusion of PG internal control in the PCR mix.

  Kit Content:

ONE MTB PCR KIT, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection of MTB

Detection Range:

2- Quantitative Real Time PCR (qPCR) Kits:

2.1- HBV qPCR Kit:

Principle:

The HBV qPCR kit is used to detect and quantitate HBV based on the amplification of the specific DNA from the S gene of the HBV genome. The advantages of the kit are: (1) Effective total DNA extraction from sera with ProGene (PG) DNA extraction kit; (2) Use of PG primers to reach the highest sensitivity in the PCR; (3) Elimination of PCR carry-over with the built-in decontamination system in the PCR mix; (4) Inclusion of PG internal control in the PCR mix.

 Kit Content:

ONE HBV qPCR Kit, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection and Quantitation of HBV

Detection Range:

Minimum - Maximum Detection Limit                      100 - 100,000,000 copies/ml

2.2- HCV qPCR Kit:

Principle:

The HCV qPCR kit is used to detect and quantitate HCV using Taqman^TM probe as the reporter to detect the products amplified from a 5’ region of the HCV genome. The advantages of the kit are: (1) Effective extraction of total RNA from the sera with ProGene (PG) RNA Extraction System; (2) Effective cDNA synthesis with PG cDNA Synthesis Kit; (3) Use of PG primers to reach the highest sensitivity in the PCR; (4) Elimination of PCR carry-over with the built-in decontamination system in the PCR Mix; (5) Inclusion of PG internal control in the PCR Mix.

 Kit Content:

ONE HCV qPCR Kit, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection and Quantitation of HCV

Detection Range:

Minimum - Maximum Detection Limit                      100 - 10,000,000 copies/ml

2.3- HIV qPCR Kit:

Principle:

The HIV qPCR kit is used for detection and quantitation of HIV in plasma based on having Taqman^TM probe as the reporter to detect the products amplified from a specific gene fragment of the HIV genome. The advantages of the kit are: (1) Highly effective extraction of total RNA from plasma with ProGene (PG) RNA Extraction System; (2) Highly effective cDNA synthesis with PG cDNA synthesis kit; (3) Use of PG primers to reach the highest sensitivity in the PCR; (4) No PCR carry-over with built-in decontamination in PG PCR Mix; (5) inhibitor control with PG PCR Mix.

  Kit Content:

ONE HIV qPCR KIT, made and validated in the USA, is designed to run up to 50 samples. Customized kits are available. Contact us at ucgl@progene.us for any inquiries.

Kit Usage:

Detection and Quantitation of HIV

Detection Range:

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