Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of "Non-Competitive" SAC for qPCR Assays.
assay
clinical
control
false negative
infection control
pandemic
qPCR
sampling
screening
test
Journal
Diagnostics (Basel, Switzerland)
ISSN: 2075-4418
Titre abrégé: Diagnostics (Basel)
Pays: Switzerland
ID NLM: 101658402
Informations de publication
Date de publication:
22 Jun 2021
22 Jun 2021
Historique:
received:
30
05
2021
revised:
15
06
2021
accepted:
20
06
2021
entrez:
2
7
2021
pubmed:
3
7
2021
medline:
3
7
2021
Statut:
epublish
Résumé
Sample Adequacy Control (SAC) has critical analytical, clinical and epidemiological value that increases confidence in a negative test result. The SAC is an integral qPCR assay control, which ensures that all pre-analytical and analytical steps are adequate for accurate testing and reporting. As such, a negative SAC with a negative result on pathogen screen specifies that the result should be reported as inconclusive instead of negative. Despite this, many regulatory approved tests do not incorporate SAC into their assay design. Herein, we emphasize the universal value of SAC and offer for the first time, a simple technical strategy to introduce non-competitive SAC which does not interfere with the limit of detection for the screened pathogen. Integration of SAC can provide key benefits towards identifying, isolating, quarantining and contact tracing infected individuals and in turn can improve worldwide efforts in infection control.
Identifiants
pubmed: 34206413
pii: diagnostics11071133
doi: 10.3390/diagnostics11071133
pmc: PMC8305439
pii:
doi:
Types de publication
Journal Article
Langues
eng
Références
Acta Cytol. 2014;58(5):439-45
pubmed: 25376096
J Clin Virol. 2021 Apr;137:104756
pubmed: 33662921
Diagnostics (Basel). 2020 Oct 23;10(11):
pubmed: 33114057
Optom Vis Sci. 1998 Jul;75(7):461
pubmed: 9703033
BMC Med. 2020 Nov 4;18(1):346
pubmed: 33143712
J Appl Physiol (1985). 2017 Jan 1;122(1):91-95
pubmed: 27909232
J Infect. 2021 Mar;82(3):414-451
pubmed: 33131699
Virol J. 2021 Apr 7;18(1):71
pubmed: 33827618
Clin Chem. 2000 Nov;46(11):1738-43
pubmed: 11067807
Sci Rep. 2020 Dec 17;10(1):22214
pubmed: 33335187
PLoS One. 2016 Aug 22;11(8):e0161403
pubmed: 27547971
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32350048
Front Med (Lausanne). 2020 Aug 28;7:562
pubmed: 32984389
Sex Transm Dis. 2017 Jan;44(1):67-68
pubmed: 27898567
Int J Infect Dis. 2021 Jan;102:14-16
pubmed: 33115681
Clin Transl Sci. 2017 Nov;10(6):470-479
pubmed: 28675646
Clin Chem. 2009 Apr;55(4):611-22
pubmed: 19246619
Int J Mol Sci. 2021 Feb 28;22(5):
pubmed: 33671091
Mol Biotechnol. 1995 Apr;3(2):129-34
pubmed: 7620973
J Clin Virol. 2020 Jul;128:104454
pubmed: 32485473
J Mol Diagn. 2014 May;16(3):305-13
pubmed: 24607271
Methods Mol Biol. 2011;687:231-43
pubmed: 20967612
PLoS One. 2020 Dec 31;15(12):e0244824
pubmed: 33382830
Matter. 2020 Nov 4;3(5):1589-1600
pubmed: 33043290
J Clin Virol. 2004 Mar;29(3):171-8
pubmed: 14962786
J Infect Public Health. 2018 Mar - Apr;11(2):234-237
pubmed: 28801105
Am J Infect Control. 2021 Mar 24;:
pubmed: 33774101
Heliyon. 2020 Mar 18;6(3):e03571
pubmed: 32211545
PLoS One. 2012;7(11):e48508
pubmed: 23155387
J Infect Public Health. 2020 Jul;13(7):991-993
pubmed: 32037201
Diagn Microbiol Infect Dis. 2015 Sep;83(1):1-6
pubmed: 26008123
Nucleic Acids Res. 2001 May 1;29(9):e45
pubmed: 11328886
Dan Med J. 2020 Aug 7;67(9):
pubmed: 32800072
J Clin Microbiol. 2021 Mar 19;59(4):
pubmed: 33436456
Cold Spring Harb Protoc. 2018 May 1;2018(5):
pubmed: 29717053
BMC Bioinformatics. 2007 Apr 20;8:131
pubmed: 17445280
Semergen. 2020 Aug;46 Suppl 1:6-11
pubmed: 32651152
Int J Infect Dis. 2020 Oct;99:190-192
pubmed: 32745627
Clin Infect Dis. 2021 Jun 1;72(11):e921
pubmed: 32986798
Int J Mol Sci. 2020 Apr 24;21(8):
pubmed: 32344568
J Med Virol. 2021 Mar;93(3):1288-1295
pubmed: 32890414
PLoS One. 2020 Oct 30;15(10):e0241542
pubmed: 33125422
Int J Gynaecol Obstet. 1995 Dec;51(3):225-8
pubmed: 8745087
Proc Natl Acad Sci U S A. 2005 Jun 14;102(24):8609-14
pubmed: 15937116
Biotechniques. 1996 Mar;20(3):478-85
pubmed: 8679209