(248 days)
The E. histolytica Test can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis.
The kit, which includes ready-to-use reagents, contains microtiter wells coated with polyclonal antibody, positive control reagent, monoclonal-antibody conjugate, diluent, two component substrate, wash solution, and intensifier. The microtiter wells coated with polyclonal antibody "capture" the adhesin and the monoclonal antibodyconjugate serves as the "detecting" antibody. The polyclonal antibody used to coat the wells is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to prepare the conjugate is prepared from mouse ascites fluid. The E. histolytica Test is to be used in an ELISA format.
Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with zymodeme analysis of > 93% | > 93% correlation with zymodeme analysis |
Study Details
-
Sample size used for the test set and the data provenance: The document does not explicitly state the exact sample size. It mentions "stool specimens in areas where amebiasis is endemic," implying a prospective or at least recently collected retrospective set from endemic regions globally.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The text does not specify the number of experts or their qualifications. The ground truth method (zymodeme analysis) is described as "available only in a select number of clinical laboratories around the world," suggesting specialized expertise is involved in performing this analysis, but not in a consensus reading of results.
-
Adjudication method for the test set: Not applicable, as the ground truth (zymodeme analysis) is presented as a definitive biochemical method, not requiring expert adjudication in the traditional sense of image or clinical interpretation.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ELISA diagnostic test, not an AI-assisted diagnostic tool or an imaging modality that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device's performance stands alone, comparing its ELISA results directly against zymodeme analysis. It is an in vitro diagnostic test, not requiring human interpretation of complex outputs.
-
The type of ground truth used: Zymodeme analysis of Entamoeba isolates cultured from stool specimens. This is described as the "gold standard" for distinguishing between pathogenic E. histolytica and non-pathogenic E. dispar.
-
The sample size for the training set: Not explicitly stated. The document describes the "clinical evaluations" and comparison with zymodeme analysis, implying a single evaluation set rather than a distinct training set. For an ELISA kit, "training" would typically refer to assay development and optimization, rather than machine learning training.
-
How the ground truth for the training set was established: Not applicable in the context of an ELISA kit with machine learning "training" as described above. The ground truth for the performance evaluation (test set) was established by zymodeme analysis.
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.