Molecular Methods and Platforms for Infectious Diseases Testing A Review of FDA-Approved and Cleared Assays

被引：74

作者：

Emmadi, Rajyasree ^{[1
]}

Boonyaratanakomkit, Jerry B. ^{[2
]}

Selvarangan, Rangaraj ^{[3
]}

Shyamala, Venkatakrishna ^{[4
]}

Zimmer, Barbara L. ^{[5
]}

Williams, Laurina ^{[6
]}

Bryant, Bonita ^{[7
]}

Schutzbank, Ted ^{[8
]}

Schoonmaker, Michele M. ^{[9
]}

Wilson, Jean A. Amos ^{[10
]}

Hall, Leslie ^{[11
]}

Pancholi, Preeti ^{[12
]}

Bernard, Kathryn ^{[13
]}

机构：

[1] Univ Illinois, Dept Pathol, Chicago, IL 60612 USA

[2] AcroMetrix, Life Technol, Benicia, CA USA

[3] Univ Missouri, Sch Med, Childrens Mercy Hosp, Kansas City, MO 64108 USA

[4] Mol Diagnost & Blood Testings, N Potomac, MD USA

[5] Siemens Healthcare Diagnost, W Sacramento, CA USA

[6] Ctr Dis Control & Prevent, Atlanta, GA USA

[7] Access Genet LLC, Eden Prairie, MN USA

[8] Covance Cent Lab Serv, Indianapolis, IN USA

[9] Cepheid, Sunnyvale, CA USA

[10] Berkeley Heartlab, Alameda, CA USA

[11] Mayo Clin, Div Lab Med, Rochester, MN 55905 USA

[12] Ohio State Univ, Dept Pathol, Med Ctr, Columbus, OH 43210 USA

[13] Publ Hlth Agcy Canada, Natl Microbiol Lab, Winnipeg, MB, Canada

来源：

JOURNAL OF MOLECULAR DIAGNOSTICS | 2011年 / 13卷 / 06期

关键词：

COBAS AMPLIPREP/COBAS TAQMAN; IN-SITU HYBRIDIZATION; STAPHYLOCOCCUS-AUREUS STRAINS; REAL-TIME PCR; COAGULASE-NEGATIVE STAPHYLOCOCCI; VIRUS REVERSE-TRANSCRIPTASE; NUCLEIC-ACID AMPLIFICATION; PLASMA LOAD DISCREPANCIES; HIV-1 MONITOR VERSION-1.5; HUMAN-PAPILLOMAVIRUS DNA;

D O I：

10.1016/j.jmoldx.2011.05.011

中图分类号：

R36 [病理学];

学科分类号：

100104 ;

摘要：

The superior sensitivity and specificity associated with the use of molecular assays has greatly improved the field of infectious disease diagnostics by providing clinicians with results that are both accurate and rapidly obtained. Herein, we review molecularly based infectious disease diagnostic tests that are Food and Drug Administration approved or cleared and commercially available in the United States as of December 31, 2010. We describe specific assays and their performance, as stated in the Food and Drug Administration's Summary of Safety and Effectiveness Data or the Office of In Vitro Diagnostic Device Evaluation and Safety's decision summaries, product inserts, or peer-reviewed literature. We summarize indications for testing, limitations, and challenges related to implementation in a clinical laboratory setting for a wide variety of common pathogens. The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term. (J Mol Diagn 2011, 13.583-604; DOI: 10.1016/j.jmoldx.2011.05.011)

引用

页码：583 / 604

页数：22

共 92 条

[11] A Population-Based Clinical Trial Comparing Endocervical High-Risk HPV Testing Using Hybrid Capture 2 and Cervista From the SHENCCAST II Study [J].