(96 days)
The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.
The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
K971393 Mycoplasma IgG ELISA Test Kit: Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mycoplasma IgG ELISA Test Kit are primarily defined by its "relative" performance against a predicate commercial IFA kit, rather than absolute diagnostic accuracy against a confirmed disease state.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Study 1) | Reported Device Performance (Study 2) |
|---|---|---|---|
| Relative Sensitivity | Not explicitly stated, but generally expected to be high. | 95.1% (95% CI: 91.2% - 99.0%) | 98.5% (95% CI: 96.4% - 100.0%) |
| Relative Specificity | Not explicitly stated, but generally expected to be reasonably high. | 55.6% (95% CI: 40.7% - 70.4%) | 45.9% (95% CI: 29.6% - 62.3%) |
| Relative Agreement | Not explicitly stated, but generally expected to be high. | 84.5% (95% CI: 78.1% - 90.1%) | 87.1% (95% CI: 82.0% - 92.3%) |
| Linearity (r-value) | r ≥ 0.974 | All r-values ≥ 0.974 (for 20 positive sera) | Not applicable (linearity assessed for all 20 sera) |
| Paired Sera Sensitivity | 100% for detecting a four-fold increase in antibody level. | 100% (56/56 pairs showed >46% rise in ISR values) | 100% (7/7 pairs showed >46% rise in ISR values for CF comparison) |
| Precision (CV) | Intra and Inter-assay CV 0.987 | > 0.987 (between three sites) | Not applicable |
| Reproducibility (Percent Agreement of Expected Results) | Not explicitly stated. | 99.3% (145/146 excluding equivocals) | Not applicable |
Note on "Relative" Performance: The report explicitly states, "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This is crucial context for interpreting the results.
2. Sample Size and Data Provenance
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Test Set (Comparative Studies):
- Study 1: 187 frozen retrospective sera.
- Study 2: 176 frozen retrospective sera.
- Data Provenance: From two R&D laboratories at commercial companies in Maryland and New York, affiliated with the manufacturer. Sera in Study 1 were from "normal individuals of various ages, gender, from Lyme diseases endemic and non-endemic areas." Sera in Study 2 were "randomly selected sera from normal individuals of various ages, gender, and geographical location." Crucially, none of the performance characteristics were established with specimens from patients having documented mycoplasma infections.
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Test Set (Linearity): 20 positive sera (serially diluted).
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Test Set (Paired Sera Evaluation): 56 pairs of sera (acute sera with ISR
§ 866.3375
Mycoplasma spp. serological reagents.(a)
Identification. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms.Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.