Comparison of a novel chemiluminescence immunoassay with the passive agglutination method for the diagnosis of Mycoplasma pneumoniae infection in children
Introduction
Mycoplasma pneumoniae is a common cause of community-acquired pneumonia (CAP) in children around the world (Vervloet et al., 2007). Previous studies have shown that M. pneumoniae infections accounted for 30% to 37% of CAP cases in children (Gao et al., 2019; Qu et al., 2019). In children, M. pneumoniae infection can result in severe pneumonia, requiring hospitalization (Diaz and Winchell, 2016; Defilippi et al., 2008; Winchell, 2013).
Due to the absence of typical and specific clinical features in the early stage of a M. pneumoniae infection, sensitive and specific laboratory indicators for early diagnosis and treatment of M. pneumoniae are urgently needed. Currently, the common methods for the identification of M. pneumoniae infections include cultures, polymerase chain reactions (PCRs), and serological tests. Although cultures are the gold standard for the detection of M. pneumoniae infection, few laboratories use cultures for diagnosis of M. pneumoniae infections due to the need for fastidious growth requirements and extensive time required (Waites et al., 2008; She et al., 2010). PCR is another reliable detection method with superior sensitivity in detecting M. pneumoniae infection in comparison with serology and culture; however, its specificity is inadequate and it cannot be used to distinguish between asymptomatic and acute infections (Waites et al., 2008). Serological tests, such as the indirect immunofluorescence assay (IFA), passive agglutination (PA), and enzyme-linked immunosorbent assay (ELISA) are the most commonly used serological tests. However, all these traditional serological tests have specific limitations, such as complicated operation procedures, extensive time consumption, and difficult automation (Beersma et al., 2005; Diederen et al., 2006; Li et al., 2017). Therefore, the development of new methods with simple operation procedures, higher sensitivity, and higher specificity for rapid diagnosis of M. pneumoniae infections is needed.
A chemiluminescence immunoassay (CLIA) can automatically and quickly detect IgM and IgG antibodies with high sensitivity, and it has been increasingly used to detect M. pneumoniae infections in recent times. The purpose of the present study was to evaluate CLIA compared to PA in detecting M. pneumoniae infections in children.
Section snippets
Patients
Children suspected of M. pneumoniae infections were enrolled from September 2018 and December 2019 at the Second Affiliated Hospital of Guangxi Medical University. All children had respiratory symptoms, such as fever (≥38 °C), cough, acute bronchitis, and were diagnosed with upper or lower respiratory tract infection. The study was approved by the Ethics Committee of the Second Affiliated Hospital of Guangxi Medical University and written informed consent was obtained from all the children's
Baseline characteristics
A total of 291 patients were enrolled in the present study, including 158 males (54%) and 133 females (46%). The mean age of the patients was 3.6 ± 2.5 years (range, 0–16 years). The clinical and demographic data were collected, including white blood cells (WBC), C-reactive protein (CRP), lactate dehydrogenase (LDH), and erythrocyte sedimentation rate (ESR). The mean level of serum WBC was 13.9 ± 3.1 109/L; CRP, 28.7 ± 11.1 mg/L; ESR, 40.5 ± 15.3 mm/h; and LDH, 305.2 ± 42.3 U/L (Table 1). The
Discussion
M. pneumoniae is an important cause of upper and lower respiratory tract infections, especially in children and adolescents. Although the infections are asymptomatic and self-limited in most patients, approximately 18% of pediatric patients require hospitalization in China owing to extra pulmonary complications or severe pneumonia. The early diagnosis of pneumonia due to M. pneumoniae is important for deciding treatment including the choice of proper antibiotics. Serological tests are the most
Conclusion
In conclusion, this study showed a high agreement between the PA and CLIA methods in detecting M. pneumoniae infections. Compared with PA, CLIA is more reliable, faster, sensitive, and accurate for the detection of M. pneumoniae antibodies. Finally, CLIA may be used as an alternative test with better sensitivity compared to PA for the diagnosis of M. pneumoniae infections.
Author statement
I have made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND.
I have drafted the work or revised it critically for important intellectual content; AND I have approved the final version to be published; AND.
I agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Li Xie and Shiyi
Declaration of Competing Interest
The authors have declared no conflict of interest.
Acknowledgements
This work was supported by Guangxi Natural Science Foundation for Young Scientists (2017GXNSFBA198068).
References (16)
- et al.
Epidemiology and clinical features of Mycoplasma pneumoniae infection in children
Resp. Med.
(2008) - et al.
Molecular characterization and analysis of mycoplasma pneumoniae among patients of all ages with community-acquired pneumonia during an epidemic in China
Int. J. Infect. Dis.
(2019) - et al.
Evaluation of 12 commercial tests and the complement fixation test for Mycoplasma pneumoniae-specific immunoglobulin G (IgG) and IgM antibodies, with PCR used as the “gold standard”
J. Clin. Microbiol.
(2005) - et al.
Comparison of chemiluminescence immunoassay, enzyme-linked immunosorbent assay and passive agglutination for diagnosis of Mycoplasma pneumoniae infection
Ther. Clin. Risk Manag.
(2018) - et al.
The evolution of advanced molecular diagnostics for the detection and characterization of Mycoplasmapneumoniae
Front. Microbiol.
(2016) - et al.
Evaluation of Vircell enzyme-linked immunosorbent assay and indirect immunofluorescence assay for detection of antibodies against Legionella pneumophila
Clin. Vaccine Immunol.
(2006) - et al.
Rapid detection of Mycoplasma pneumoniae IgM antibodies in pediatric patients using ImmunoCard Mycoplasma compared to conventional enzyme immunoassays
Eur. J. Clin. Microbiol. Infect. Dis.
(2004) - et al.
The epidemiology of paediatric Mycoplasma pneumoniae pneumonia in North China: 2006 to 2016
Epidemiol. Infect.
(2019)
Cited by (12)
Clinical role of M. pneumoniae typing antibody detected by chemiluminescent immunoassay in the diagnosis of Mycoplasma pneumoniae pneumonia in children
2022, International ImmunopharmacologyCitation Excerpt :Due to the absence of typical and specific clinical features in the early stage of M. pneumoniae infection, sensitive and specific laboratory indicators for early diagnosis and treatment of M. pneumoniae are urgently needed. CLIA can automatically and quickly detect MP-IgM and MP-IgG levels with high specificity and sensitivity, which has been increasingly used to detect M. pneumoniae infections in recent times [20,36]. This study would raise the awareness of early diagnosis by M. pneumoniae typing antibodies, as well as prompt intervention to reduces macrolide-resistant strains and sequelae of children with M. pneumoniae pneumonia.
Risk factors for the development of post-infectious bronchiolitis obliterans after Mycoplasma pneumoniae pneumonia in the era of increasing macrolide resistance
2020, Respiratory MedicineCitation Excerpt :The Institutional Review Board (IRB) approved this study with a waiver of informed consent (IRB no. CNUH-2019-261). The diagnosis of MP pneumonia was based on the presence of all three items: (1) acute respiratory symptoms, such as productive cough with sputum and rhinorrhea in previously healthy children, (2) chest radiography findings suggestive of pneumonia with/without abnormal lung sounds, such as wheezing or crackle, and (3) positive polymerase chain reaction (PCR) results for MP or positive or higher titers of MP-specific IgM antibodies using chemiluminescence immunoassay [11]. PIBO was defined based on a combination of medical history and clinical and radiologic findings, including mosaic ground-glass patterns, air-trapping, bronchial thickening with/without bronchiectasis or atelectasis on chest high-resolution computed tomography (HRCT) in previously healthy children [9,12,13].
Establishment of Sensitive Sandwich-Type Chemiluminescence Immunoassay for Interleukin-18 in Urinary Samples
2023, Applied Biochemistry and Biotechnology
- 1
These authors contributed equally to this work