Applying context of use to quantitative polymerase chain reaction method validation and analysis : a recommendation from the European Bioanalysis Forum
Polymerase chain reaction (PCR) is widely used in various fields of laboratory testing, ranging from forensic, molecular biology, medical and diagnostic applications to a wide array of basic research purposes. COVID-19 infection testing has brought the three-letter PCR abbreviation into the vocabulary of billions of people, making it likely the most well-known laboratory test worldwide. With new modalities and translational medicine gaining importance in pharmaceutical research and development, PCR or more specifically, quantitative PCR (qPCR) is now becoming a standard tool in the (regulated) bioanalytical laboratory, driving the bioanalytical community to define best practices for method development, characterization and validation. In absence of specific guidance from health authorities, qPCR may be vulnerable to scope creep from pharmacokinetics (PK) assay validation as defined in bioanalytical method validation guidance/guidelines. In this manuscript, the European Bioanalysis Forum builds a rationale for applying context of use principles when defining requirements for qPCR assay performance and validation criteria.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
Bioanalysis - 13(2021), 23 vom: 28. Dez., Seite 1723-1729 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Laurén, Anna [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Assay development |
|---|
| Anmerkungen: |
Date Completed 30.11.2021 Date Revised 30.11.2021 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.4155/bio-2021-0218 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM332470083 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM332470083 | ||
| 003 | DE-627 | ||
| 005 | 20231225215635.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.4155/bio-2021-0218 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1108.xml |
| 035 | |a (DE-627)NLM332470083 | ||
| 035 | |a (NLM)34708666 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Laurén, Anna |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Applying context of use to quantitative polymerase chain reaction method validation and analysis |b a recommendation from the European Bioanalysis Forum |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 30.11.2021 | ||
| 500 | |a Date Revised 30.11.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Polymerase chain reaction (PCR) is widely used in various fields of laboratory testing, ranging from forensic, molecular biology, medical and diagnostic applications to a wide array of basic research purposes. COVID-19 infection testing has brought the three-letter PCR abbreviation into the vocabulary of billions of people, making it likely the most well-known laboratory test worldwide. With new modalities and translational medicine gaining importance in pharmaceutical research and development, PCR or more specifically, quantitative PCR (qPCR) is now becoming a standard tool in the (regulated) bioanalytical laboratory, driving the bioanalytical community to define best practices for method development, characterization and validation. In absence of specific guidance from health authorities, qPCR may be vulnerable to scope creep from pharmacokinetics (PK) assay validation as defined in bioanalytical method validation guidance/guidelines. In this manuscript, the European Bioanalysis Forum builds a rationale for applying context of use principles when defining requirements for qPCR assay performance and validation criteria | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a assay development | |
| 650 | 4 | |a assay validation | |
| 650 | 4 | |a biomarker | |
| 650 | 4 | |a context of use | |
| 650 | 4 | |a polymerase chain reaction | |
| 650 | 4 | |a quantitative polymerase chain reaction | |
| 650 | 4 | |a regulated bioanalysis | |
| 700 | 1 | |a Braun, Manuela |e verfasserin |4 aut | |
| 700 | 1 | |a Byrne, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Cazzin, Chiara |e verfasserin |4 aut | |
| 700 | 1 | |a Colletti, Kelly |e verfasserin |4 aut | |
| 700 | 1 | |a Cox, Chris |e verfasserin |4 aut | |
| 700 | 1 | |a Dietz, Lisa |e verfasserin |4 aut | |
| 700 | 1 | |a Emrich, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Geddes, Kristin |e verfasserin |4 aut | |
| 700 | 1 | |a Herr, Kate |e verfasserin |4 aut | |
| 700 | 1 | |a Iles, Tracy |e verfasserin |4 aut | |
| 700 | 1 | |a Rogue, Alexandra |e verfasserin |4 aut | |
| 700 | 1 | |a Verlinden, Yvan |e verfasserin |4 aut | |
| 700 | 1 | |a Timmerman, Philip |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Bioanalysis |d 2009 |g 13(2021), 23 vom: 28. Dez., Seite 1723-1729 |w (DE-627)NLM196969840 |x 1757-6199 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2021 |g number:23 |g day:28 |g month:12 |g pages:1723-1729 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.4155/bio-2021-0218 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2021 |e 23 |b 28 |c 12 |h 1723-1729 | ||