(182 days)
The MONOLISA™ Anti-HAV EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of total antibodies (IgG and IgM) to Hepatitis A Virus (anti-HAV) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This kit can be used as an aid in the diagnosis of acute or past Hepatitis A Virus (HAV) infection or as an aid in the identification of HAVsusceptible individuals for vaccination. However, any diagnosis should take into consideration the patient's clinical history and symptoms, as well as serological data.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, and cord blood or neonatal specimens.
WARNING : This assay is not intended for screening blood or solid or soft tissue donors.
The MONOLISA™ Anti-HAV EIA is an enzyme immunoassay (competitive assay format) for the detection of total antibodies to Hepatitis A virus. In the assay procedure, patient specimens, a calibrator and controls are incubated with HAV antigen in microwells that have been coated with mouse monoclonal anti-Hepatitis A antibodies to HAV present in a specimen or control will complex with the HAV antigen reagent and with antibodies coated on the microwells. Excess sample and HAV Viral antigen reagent are removed by a wash step. The conjugate (containing horseradish peroxidase-labeled mouse monoclonal antibody to HAV) is subsequently added to the microwells and incubated. The conjuqate binds to the HAV antigen bound to the microwell in the absence of antibodies to HAV from the specimen. Excess conjugate is removed by a wash step, and a TMB Chromogen / Substrate solution is added to the microwells and allowed to incubate. If a sample does not contain anti-HAV antibodies, the bound enzyme (HRP) causes the colorless tetramethylbenzidine (TMB) in the Chromogen solution to change to blue. The blue color turns yellow after the addition of a Stopping Solution. If a sample contains anti-HAV antibodies, the Chromogen / Substrate Solution in the well remains colorless during the substrate incubation, and after the addition of the Stopping Solution. The color intensity is measured spectrophotometrically.
Absorbance value readings for patient specimens are compared to the Cutoff value determined by the mean of the Calibrator absorbance values.
Here's a breakdown of the acceptance criteria and study information for the MONOLISA™ Anti-HAV EIA, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implied by reported performance vs. comparative assay) | Reported Device Performance (MONOLISA™ Anti-HAV EIA) |
|---|---|---|
| Overall Positive Percent Agreement (PPA) with comparative assay | Not explicitly stated, but generally expected to be very high (e.g., >95%) | 99.5% (931/936) with 95% CI (98.8% - 99.8%) |
| Overall Negative Percent Agreement (NPA) with comparative assay | Not explicitly stated, but generally expected to be very high (e.g., >95%) | 96.2% (378/393) with 95% CI (93.8% - 97.9%) |
| PPA for US population | Not explicitly stated | 98.8% (237/240) with 95% CI (96.4% - 99.7%) |
| NPA for US population | Not explicitly stated | 92.6% (151/163) with 95% CI (87.5% - 96.1%) |
| PPA for European population | Not explicitly stated | 99.7% (610/612) with 95% CI (98.8% - 99.9%) |
| NPA for European population | Not explicitly stated | 98.7% (227/230) with 95% CI (96.2% - 99.7%) |
| PPA for Acute HAV Infection | Not explicitly stated | 100% (84/84) with 95% CI (96.5% - 100%) |
| PPA for Pediatric Subjects | Not explicitly stated | 100% (29/29) with 95% CI (90.2% - 100%) |
| NPA for Pediatric Subjects | Not explicitly stated | 96.8% (30/31) with 95% CI (83.3% - 99.9%) |
| Seroconversion Panel Sensitivity (compared to comparative assay) | Equivalent or more sensitive | Equivalent to or more sensitive in 6/6 panels. |
| Device Precision (Within-run, Between-run, Between-day CV) | CVs typically expected to be low (e.g., |
§ 866.3310 Hepatitis A virus (HAV) serological assays.
(a)
Identification. HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.(b)
Classification. Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.