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Evaluation of a multiplex PCR assay for detection of respiratory viruses and Mycoplasma pneumoniae in oropharyngeal swab samples from outpatients.
J Clin Lab Anal 2019; :e23032JC

Abstract

BACKGROUND

Respiratory viruses, such as influenza viruses, initially infect the upper airways but can manifest as severe lower respiratory tract infections in high-risk patients with significant morbidity and mortality. For syndromic diagnosis, several multiplex nucleic acid amplification tests have been developed for clinics, of which SureX 13 Respiratory Pathogen Multiplex Kit (ResP) can simultaneously detect 13 pathogens directly from airway secretion specimens. The organisms identified are influenza virus A, influenza virus A pdmH1N1 (2009), influenza virus A H3N2, influenza virus B, adenovirus, boca virus, rhinovirus, parainfluenza virus, coronavirus, respiratory syncytial virus, human metapneumovirus, Mycoplasma pneumoniae, and Chlamydia.

METHODS

This study provides performance evaluation data of this assay by comparing with pathogen-specific PCRs from oropharyngeal swab samples.

RESULTS

Ten pathogens were detected in this assay, of which rhinovirus, adenovirus, and influenza virus A pdmH1N1 (2009) were the most common. The overall agreement between the ResP and the comparator tests was 93.8%. The ResP demonstrated 86.5% agreement for positive results and 97.8% agreement for negative results.

CONCLUSION

The ResP assay demonstrated a highly concordant performance comparing with pathogen-specific PCRs for detection of respiratory pathogens in oropharyngeal swabs from outpatients and could aid in the diagnosis of respiratory infections in a variety of clinical scenarios.

Authors+Show Affiliations

Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Ningbo Health Gene Technologies Co., Ltd, Ningbo, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.Ningbo Health Gene Technologies Co., Ltd, Ningbo, China.Guangzhou Center for Disease Control and Prevention, Guangzhou, China.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31628684

Citation

Zhang, Ying, et al. "Evaluation of a Multiplex PCR Assay for Detection of Respiratory Viruses and Mycoplasma Pneumoniae in Oropharyngeal Swab Samples From Outpatients." Journal of Clinical Laboratory Analysis, 2019, pp. e23032.
Zhang Y, Cao L, Xu Z, et al. Evaluation of a multiplex PCR assay for detection of respiratory viruses and Mycoplasma pneumoniae in oropharyngeal swab samples from outpatients. J Clin Lab Anal. 2019.
Zhang, Y., Cao, L., Xu, Z., Zhu, P., Huang, B., Li, K., ... Di, B. (2019). Evaluation of a multiplex PCR assay for detection of respiratory viruses and Mycoplasma pneumoniae in oropharyngeal swab samples from outpatients. Journal of Clinical Laboratory Analysis, pp. e23032. doi:10.1002/jcla.23032.
Zhang Y, et al. Evaluation of a Multiplex PCR Assay for Detection of Respiratory Viruses and Mycoplasma Pneumoniae in Oropharyngeal Swab Samples From Outpatients. J Clin Lab Anal. 2019 Oct 19;e23032. PubMed PMID: 31628684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a multiplex PCR assay for detection of respiratory viruses and Mycoplasma pneumoniae in oropharyngeal swab samples from outpatients. AU - Zhang,Ying, AU - Cao,Lan, AU - Xu,Zhi, AU - Zhu,Pingting, AU - Huang,Bing, AU - Li,Kuibiao, AU - Xu,Yang, AU - Zhang,Zhoubin, AU - Wu,Yong, AU - Di,Biao, Y1 - 2019/10/19/ PY - 2019/07/01/received PY - 2019/08/12/revised PY - 2019/08/12/accepted PY - 2019/10/20/entrez KW - acute respiratory infections KW - influenza virus A KW - multiplex PCR KW - oropharyngeal swab KW - respiratory virus SP - e23032 EP - e23032 JF - Journal of clinical laboratory analysis JO - J. Clin. Lab. Anal. N2 - BACKGROUND: Respiratory viruses, such as influenza viruses, initially infect the upper airways but can manifest as severe lower respiratory tract infections in high-risk patients with significant morbidity and mortality. For syndromic diagnosis, several multiplex nucleic acid amplification tests have been developed for clinics, of which SureX 13 Respiratory Pathogen Multiplex Kit (ResP) can simultaneously detect 13 pathogens directly from airway secretion specimens. The organisms identified are influenza virus A, influenza virus A pdmH1N1 (2009), influenza virus A H3N2, influenza virus B, adenovirus, boca virus, rhinovirus, parainfluenza virus, coronavirus, respiratory syncytial virus, human metapneumovirus, Mycoplasma pneumoniae, and Chlamydia. METHODS: This study provides performance evaluation data of this assay by comparing with pathogen-specific PCRs from oropharyngeal swab samples. RESULTS: Ten pathogens were detected in this assay, of which rhinovirus, adenovirus, and influenza virus A pdmH1N1 (2009) were the most common. The overall agreement between the ResP and the comparator tests was 93.8%. The ResP demonstrated 86.5% agreement for positive results and 97.8% agreement for negative results. CONCLUSION: The ResP assay demonstrated a highly concordant performance comparing with pathogen-specific PCRs for detection of respiratory pathogens in oropharyngeal swabs from outpatients and could aid in the diagnosis of respiratory infections in a variety of clinical scenarios. SN - 1098-2825 UR - https://www.unboundmedicine.com/medline/citation/31628684/Evaluation_of_a_multiplex_PCR_assay_for_detection_of_respiratory_viruses_and_Mycoplasma_pneumoniae_in_oropharyngeal_swab_samples_from_outpatients L2 - https://doi.org/10.1002/jcla.23032 DB - PRIME DP - Unbound Medicine ER -