Performance of Meridian ImmunoCard Mycoplasma test in a multicenter clinical trial

Abstract

Serology is the principal laboratory method used to diagnose Mycoplasma pneumoniae infection. Meridian Diagnostics has developed the ImmunoCard Mycoplasma kit, a 10-min card-based enzyme-linked immunosorbent assay (ELISA) designed to detect immunoglobulin M (IgM) antibodies to M. pneumoniae. We compared the ImmunoCard with two M. pneumoniae IgM-specific assays (immunofluorescence assay [IFA] and ELISA) and a standard complement fixation (CF) procedure using 896 specimens submitted to clinical laboratories for M. pneumoniae serology. Equivocal results obtained by CF, IFA, or ELISA were resolved by testing with an additional method or by reviewing patient chart information. The ImmunoCard had sensitivities ranging from 74% compared with the ELISA to 96% compared with CF results resolved with IFA. ImmunoCard specificities ranged from 85% compared with the IgM-specific ELISA to 98% compared with IgM-specific IFA results resolved with clinical chart review. We also compared the ImmunoCard results with consensus results of 694 specimens tested on at least two non-ImmunoCard methods because of the lack of a ''gold standard'' for M. pneumoniae serology. Overall, the ImmunoCard Mycoplasma IgM assay had 90% sensitivity, 93% specificity, and 92% agreement with the consensus results. The ImmunoCard is technically less complex and requires less equipment than the three other assays. Our results indicate that the ImmunoCard Mycoplasma IgM assay is a valid and simple procedure which can reduce technologist time (and, thus, labor cost) and turnaround time for laboratories analyzing small numbers of specimens (<10 per batch) submitted for IgM anti-M. pneumoniae testing.

New concepts of Mycoplasma pneumoniae infections in children

“…It is ideally suited for the detection of MP infection in children, and was evaluated in comparison to other types of assays with confirmed MP infection, with comparable or better overall performance than CF. [103][104][105] Another rapid EIA test (Remel Laboratories, Lenexa, KS) that qualitatively measures IgG and IgM together was also shown useful for point-of-care diagnosis of MP infections in adults. 106,107 The cost of materials to perform these rapid EIAs exceeds $10 (US) for each patient tested.…”

Prevalence of Mycoplasma IgM in children with lower respiratory tract illness

“…The Meridian ImmunoCard Mycoplasma test is a rapid enzyme immunoassay card assay designed to detect IgM antibodies to M. pneumoniae, and is widely used in pediatric practice. 8,9 Caution is required in interpretation of the results of this rapid test, however, because the specific IgM responses after Mycoplasma infection last for several months to more than 1 year. 13,14 This is also true for the present results of rapid detection tests for pathogens, because both ImmunoCard and RSV or influenza virus antigen were positive in seven patients at the same time in the present study.…”

“…The details of procedures have been previously described. 8,9 Respiratory syncytial virus (RSV) and/or influenza virus antigens were additionally determined in the patients who were suspected to have RSV or influenza virus infections in the prevalent periods of the diseases. ImmunoCard ST RSV (TFB, Tokyo, Japan) and Capilia Flue A+B (Alfresa, Osaka, Japan) rapid diagnosis kits were used for the detection of RSV and influenza antigens, respectively.…”

Comparison of the new InoDiag automated fluorescence multiplexed antigen microarray to the reference technique in the serodiagnosis of atypical bacterial pneumonia

“…For M. pneumoniae, sera received at the Timone Hospital laboratory that were obtained from patients with acute pneumonia were used. Serology was performed using ELISA (Meridien, Cincinnati, OH, USA) [18]. Nineteen sera were selected according to the following diagnostic criteria: IgM ‡1.2 and patient age £30 years (n = 10) or seroconversion (n = 5), and convalescent-phase serum (n = 4).…”