Isolation:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Extraction:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Virus:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Control:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Positive Control:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Software:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Diagnostic Assay:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Multiplex Assay:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Acid Assay:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Quantitation Assay:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Sequencing:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
Real-time Polymerase Chain Reaction:Article Title:
Article Snippet: .. Specimen Types NP swabs NP swabs Collection and Transport Medium M4 and M5 Viral Transport Medium (Remel), UVT (Becton Dickinson), UTM (Copan) Universal Transport Medium (Copan) Nucleic Acid Isolation MagNA Pure LC System (Roche), NucliSENS easyMAG (bioMérieux) NucliSENS® miniMAG extraction Kit QIAamp® MiniElute® Virus Spin Kit Instrument /Assay Platform Cepheid SmartCycler® II System Luminex 100 or 200 Time to Result 3 to 5 hours 8 hours Assay Controls Adenovirus positive DNA transcript control and an Internal Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – Features ProAdeno+ Assay Luminex RVP DNA/RNA control provided ancillary reagents not provided Results Negative Positive Unresolved Negative Positive No Call K. Standard/Guidance Documents Referenced (if applicable): • Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, August 12, 2005 • Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens • Guidance for Industry, FDA Reviewers and Compliance: Off-the-Shelf Software Use in Medical Devices, September 9, 1999 • Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, March 13, 2007 • Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay, October 9, 2009 • User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline Second Edition (CLSI EP12-A2 2008) • Protocols for Determination of Limits of Detection and Limits of Quantitation (CLSI EP-17A 2004) • Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline (CLSI MM3-A2 2006) • Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (CLSI MM9-A 2004) • Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods (CLSI MM13-P 2005) • Medical devices – Quality management systems – Requirements for regulatory purpose (ISO 13485:2003) • Medical devices - Application of risk management to medical devices (ISO 14971:2007) • Stability Testing of In Vitro Diagnostic Reagents (CEN 13640:2002) L. Test Principle: The Real Time PCR process simultaneously amplifies and detects nucleic acid targets in a single closed-tube reaction. ..
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