Ann Lab Med.  2012 Jan;32(1):44-49. 10.3343/alm.2012.32.1.44.

Evaluation of the Seeplex(R) Meningitis ACE Detection Kit for the Detection of 12 Common Bacterial and Viral Pathogens of Acute Meningitis

• Shin SY
• Kwon KC
• Park JW
• Kim JM
• Shin SY
• Koo SH

• KMID: 1781437
• DOI: http://doi.org/10.3343/alm.2012.32.1.44

Abstract

BACKGROUND
Bacterial meningitis is an infectious disease with high rates of mortality and high frequency of severe sequelae. Early identification of causative bacterial and viral pathogens is important for prompt and proper treatment of meningitis and for prevention of life-threatening clinical outcomes. In the present study, we evaluated the value of the Seeplex Meningitis ACE Detection kit (Seegene Inc., Korea), a newly developed multiplex PCR kit employing dual priming oligonucleotide methods, for diagnosing acute meningitis.
METHODS
Analytical sensitivity of the kit was studied using reference strains for each pathogen targeted by the kit, while it's analytical specificity was studied using the human genome DNA and 58 clinically well-identified reference strains. For clinical validation experiment, we used 27 control cerebrospinal fluid (CSF) samples and 78 clinical CSF samples collected from patients at the time of diagnosis of acute meningitis.
RESULTS
The lower detection limits ranged from 101 copies/microL to 5x101 copies/microL for the 12 viral and bacterial pathogens targeted. No cross-reaction was observed. In the validation study, high detection rate of 56.4% was obtained. None of the control samples tested positive, i.e., false-positive results were absent.
CONCLUSIONS
The Seeplex Meningitis ACE Detection kit showed high sensitivity, specificity, and detection rate for the identification of pathogens in clinical CSF samples. This kit may be useful for rapid identification of important acute meningitis-causing pathogens.

Keyword

Meningitis; Multiplex PCR; Dual priming oligonucleotide

MeSH Terms

Acute Disease
Adolescent
Adult
Aged
Child
Child, Preschool
Female
Humans
Infant
Male
Meningitis/*diagnosis/microbiology/virology
Middle Aged
*Polymerase Chain Reaction
RNA, Bacterial/cerebrospinal fluid
RNA, Viral/cerebrospinal fluid
Reagent Kits, Diagnostic
Sensitivity and Specificity
Sequence Analysis, RNA

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