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. 2024 Dec 18;14(1):134.
doi: 10.1186/s13568-024-01782-5.

Evaluation of three rapid assays for detecting Mycoplasma pneumoniae in nasopharyngeal specimens

Chenglin Yang  1 , Ziyi Wang  1 , Lingjun Kong  1 , Juan Du  1 , Jie Yi  2
Affiliations

Evaluation of three rapid assays for detecting Mycoplasma pneumoniae in nasopharyngeal specimens

Chenglin Yang et al. AMB Express. .

Abstract

During the 2023 autumn-winter period in China, Mycoplasma pneumoniae (MP) infections have increased. To address this, rapid and accurate MP DNA detection methods are crucial. Three nucleic acid detection assays (Ustar, Coyote Flash10, Coyote Flash 20) that are widely used in China are currently being evaluated for their effectiveness in detecting MP DNA in nasopharyngeal specimens. Reference standard materials for MP and a total of 35 NPS collected from Peking Union Medical College Hospital were tested using the Ustar, Coyote Flash10 and Coyote Flash 20 assays to assess analytical sensitivity, analytical specificity, diagnostic performance and workflow. The assays showed differing limits of detection (LOD) based on the absolute quantification of reference standards, with LODs of 500 copies/mL for the Ustar assays and 200 copies/mL for both Coyote Flash10 and Coyote Flash 20 assays. Additionally, all three assays displayed excellently analytical specificity in detecting MP DNA.The clinical correlation analysis demonstrated that the Ustar assay exhibited a sensitivity of 90.00%, specificity of 100%, positive predictive value (PPV) of 100%, and negative predictive value (NPV) of 62.50%. In contrast, both the Coyote Flash10 and Coyote Flash 20 assays displayed perfect diagnostic accuracy with 100% sensitivities, specificities, PPVs, and NPVs. Despite variations in detection principles, sample volume, and pre-preparation among the three assays, they all had a turnaround time of less than 30 min with low-throughput processing. Overall, all three rapid nucleic acid detection assays displayed excellent clinical performance in detecting MP DNA, offering a solid foundation for the quick clinical diagnosis of MP infection.

Keywords: Mycoplasma pneumoniae; Analytical sensitivity; Analytical specificity; Diagnostic performance, workflow; Rapid nucleic acid detection assays.

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Conflict of interest statement

Declarations. Ethical approval and consent to participate: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committee at PUMCH. Competing interests: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The impact of NPS on Ct values of MP DNA detected by three rapid nucleic acid detection assays with and without the interfering substance
See this image and copyright information in PMC

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