The Increasing Application of Multiplex Nucleic Acid Detection Tests to the Diagnosis of Syndromic Infections

Overview

Journal Epidemiol Infect

Publisher Cambridge University Press

Specialties Infectious Diseases
Public Health

Date 2013 Oct 8

PMID 24093495

Citations 26

Authors

J Gray

L J Coupland

Affiliations

Soon will be listed here.

Abstract

On 14 January 2013, the US Food and Drug Administration (FDA) announced permission for a multiplex nucleic acid test, the xTAG® Gastrointestinal Pathogen Panel (GPP) (Luminex Corporation, USA), which simultaneously detects 11 common viral, bacterial and parasitic causes of infectious gastroenteritis, to be marketed in the USA. This announcement reflects the current move towards the development and commercialization of detection technologies based on nucleic acid amplification techniques for diagnosis of syndromic infections. We discuss the limitations and advantages of nucleic acid amplification techniques and the recent advances in Conformité Européene - in-vitro diagnostic (CE-IVD)-approved multiplex real-time PCR kits for the simultaneous detection of multiple targets within the clinical diagnostics market.

Citing Articles

Comparison of AccuPower Diarrhea V1&V2 RT-PCR to a Chromatographic Immunoassay for Detecting Viral Pathogens from Human Diarrheal Stool Specimens.

Katic L, Mihaljevic B, Pirija M, Goic-Barisic I, Tonkic M, Novak A Trop Med Infect Dis. 2025; 10(2).

PMID: 39998037 PMC: 11860935. DOI: 10.3390/tropicalmed10020033.

Advancing quantitative PCR with color cycle multiplex amplification.

Chen W, Zhang K, Huang F, Zhao L, Waldren G, Jiang Q Nucleic Acids Res. 2024; 52(17):e81.

PMID: 39119904 PMC: 11417387. DOI: 10.1093/nar/gkae683.

Low-Density TaqMan® Array Cards for the Detection of Pathogens.

Heaney J, Rolfe K, Gleadall N, Greatorex J, Curran M Methods Microbiol. 2024; 42:199-218.

PMID: 38620215 PMC: 7172410. DOI: 10.1016/bs.mim.2015.06.002.

Current and Future Technologies for the Detection of Antibiotic-Resistant Bacteria.

Yamin D, Uskokovic V, Wakil A, Goni M, Shamsuddin S, Mustafa F Diagnostics (Basel). 2023; 13(20).

PMID: 37892067 PMC: 10606640. DOI: 10.3390/diagnostics13203246.

Next-generation molecular diagnostics: Leveraging digital technologies to enhance multiplexing in real-time PCR.

Kreitmann L, Miglietta L, Xu K, Malpartida-Cardenas K, DSouza G, Kaforou M Trends Analyt Chem. 2023; 160:116963.

PMID: 36968318 PMC: 7614363. DOI: 10.1016/j.trac.2023.116963.

References

Galar A, Leiva J, Espinosa M, Guillen-Grima F, Hernaez S, Yuste J . Clinical and economic evaluation of the impact of rapid microbiological diagnostic testing. J Infect. 2012; 65(4):302-9. DOI: 10.1016/j.jinf.2012.06.006. View

Templeton K, Scheltinga S, van den Eeden W, Graffelman A, van den Broek P, Claas E . Improved diagnosis of the etiology of community-acquired pneumonia with real-time polymerase chain reaction. Clin Infect Dis. 2005; 41(3):345-51. PMC: 7107904. DOI: 10.1086/431588. View

Barenfanger J, Drake C, Leon N, Mueller T, Troutt T . Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000; 38(8):2824-8. PMC: 87120. DOI: 10.1128/JCM.38.8.2824-2828.2000. View

Navidad J, Griswold D, Gradus M, Bhattacharyya S . Evaluation of Luminex xTAG gastrointestinal pathogen analyte-specific reagents for high-throughput, simultaneous detection of bacteria, viruses, and parasites of clinical and public health importance. J Clin Microbiol. 2013; 51(9):3018-24. PMC: 3754681. DOI: 10.1128/JCM.00896-13. View

Sakthivel S, Whitaker B, Lu X, Oliveira D, Stockman L, Kamili S . Comparison of fast-track diagnostics respiratory pathogens multiplex real-time RT-PCR assay with in-house singleplex assays for comprehensive detection of human respiratory viruses. J Virol Methods. 2012; 185(2):259-66. PMC: 7119496. DOI: 10.1016/j.jviromet.2012.07.010. View

Byington C, Castillo H, Gerber K, Daly J, Brimley L, Adams S . The effect of rapid respiratory viral diagnostic testing on antibiotic use in a children's hospital. Arch Pediatr Adolesc Med. 2002; 156(12):1230-4. DOI: 10.1001/archpedi.156.12.1230. View

Anderson T, Werno A, Barratt K, Mahagamasekera P, Murdoch D, Jennings L . Comparison of four multiplex PCR assays for the detection of viral pathogens in respiratory specimens. J Virol Methods. 2013; 191(2):118-21. PMC: 7119551. DOI: 10.1016/j.jviromet.2013.04.005. View

Yanagihara K, Kitagawa Y, Tomonaga M, Tsukasaki K, Kohno S, Seki M . Evaluation of pathogen detection from clinical samples by real-time polymerase chain reaction using a sepsis pathogen DNA detection kit. Crit Care. 2010; 14(4):R159. PMC: 2945143. DOI: 10.1186/cc9234. View

Murdoch D . Impact of rapid microbiological testing on the management of lower respiratory tract infection. Clin Infect Dis. 2005; 41(10):1445-7. DOI: 10.1086/497145. View

10.

Stark D, Al-Qassab S, Barratt J, Stanley K, Roberts T, Marriott D . Evaluation of multiplex tandem real-time PCR for detection of Cryptosporidium spp., Dientamoeba fragilis, Entamoeba histolytica, and Giardia intestinalis in clinical stool samples. J Clin Microbiol. 2010; 49(1):257-62. PMC: 3020426. DOI: 10.1128/JCM.01796-10. View

11.

Retamar P, Portillo M, Dolores Lopez-Prieto M, Rodriguez-Lopez F, Cueto M, Garcia M . Impact of inadequate empirical therapy on the mortality of patients with bloodstream infections: a propensity score-based analysis. Antimicrob Agents Chemother. 2011; 56(1):472-8. PMC: 3256027. DOI: 10.1128/AAC.00462-11. View

12.

Reddington K, Tuite N, Barry T, OGrady J, Zumla A . Advances in multiparametric molecular diagnostics technologies for respiratory tract infections. Curr Opin Pulm Med. 2013; 19(3):298-304. DOI: 10.1097/MCP.0b013e32835f1b32. View

13.

Blaschke A, Heyrend C, Byington C, Fisher M, Barker E, Garrone N . Rapid identification of pathogens from positive blood cultures by multiplex polymerase chain reaction using the FilmArray system. Diagn Microbiol Infect Dis. 2012; 74(4):349-55. PMC: 3496814. DOI: 10.1016/j.diagmicrobio.2012.08.013. View

14.

Josefson P, Stralin K, Ohlin A, Ennefors T, Dragsten B, Andersson L . Evaluation of a commercial multiplex PCR test (SeptiFast) in the etiological diagnosis of community-onset bloodstream infections. Eur J Clin Microbiol Infect Dis. 2011; 30(9):1127-34. DOI: 10.1007/s10096-011-1201-6. View

15.

van de Pol A, Wolfs T, Jansen N, van Loon A, Rossen J . Diagnostic value of real-time polymerase chain reaction to detect viruses in young children admitted to the paediatric intensive care unit with lower respiratory tract infection. Crit Care. 2006; 10(2):R61. PMC: 1550925. DOI: 10.1186/cc4895. View

16.

McAuliffe G, Anderson T, Stevens M, Adams J, Coleman R, Mahagamasekera P . Systematic application of multiplex PCR enhances the detection of bacteria, parasites, and viruses in stool samples. J Infect. 2013; 67(2):122-9. DOI: 10.1016/j.jinf.2013.04.009. View

17.

Amar C, East C, Gray J, Iturriza-Gomara M, Maclure E, McLAUCHLIN J . Detection by PCR of eight groups of enteric pathogens in 4,627 faecal samples: re-examination of the English case-control Infectious Intestinal Disease Study (1993-1996). Eur J Clin Microbiol Infect Dis. 2007; 26(5):311-23. DOI: 10.1007/s10096-007-0290-8. View

18.

Stranska R, Schuurman R, de Vos M, van Loon A . Routine use of a highly automated and internally controlled real-time PCR assay for the diagnosis of herpes simplex and varicella-zoster virus infections. J Clin Virol. 2004; 30(1):39-44. DOI: 10.1016/j.jcv.2003.08.006. View

19.

Falsey A, Becker K, Swinburne A, Nylen E, Formica M, Hennessey P . Bacterial complications of respiratory tract viral illness: a comprehensive evaluation. J Infect Dis. 2013; 208(3):432-41. PMC: 3699009. DOI: 10.1093/infdis/jit190. View

20.

Chen H, Lin W, Lin C, Hsieh W, Hsieh C, Wu M . Outcome of inadequate empirical antibiotic therapy in emergency department patients with community-onset bloodstream infections. J Antimicrob Chemother. 2012; 68(4):947-53. DOI: 10.1093/jac/dks475. View