LIAISON Biotrin Parvovirus B19 IgG Plus and Control
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus FDA PMA
- Generic Name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG FDA PMA
Identifiers
- PMA Number
- P220034 FDA PMA
- FDA Product Code
- MYL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The LIAISON Biotrin Parvovirus B19 IgG Plus is a chemiluminescent immunoassay (CLIA) designed for the qualitative detection of IgG antibodies to human parvovirus B19 (B19V) in human serum, lithium heparin, dipotassium EDTA (K2-EDTA), and sodium citrated plasma. This assay aids in diagnosing fifth disease (erythema infectiosum) and assessing exposure risk in women of childbearing age.
The test is performed exclusively on the LIAISON XL Analyzer and includes a paired control (LIAISON Biotrin Control Parvovirus B19 IgG Plus) for quality assurance. Supplied as a Class III device under FDA PMA approval (P220034), it is intended for laboratory use only and requires no special sterility or MRI safety considerations. Storage and handling follow standard immunoassay protocols.
Frequently asked questions
What types of patient samples can the LIAISON Biotrin Parvovirus B19 IgG Plus test analyze, and why is this important for clinical use?
The LIAISON Biotrin Parvovirus B19 IgG Plus is designed to analyze human serum, as well as plasma collected with lithium heparin, dipotassium EDTA (K2-EDTA), or sodium citrate. This flexibility is important because it allows clinicians to use samples that are commonly collected for routine testing, reducing the need for additional phlebotomy or special handling. The test is specifically intended for qualitative detection of IgG antibodies to parvovirus B19, which helps in diagnosing fifth disease (erythema infectiosum) and assessing exposure risk in women of childbearing age.
Is this test compatible with any specific laboratory equipment, and if so, how does that affect its use?
Yes, the LIAISON Biotrin Parvovirus B19 IgG Plus is **exclusively** designed to be performed on the LIAISON XL Analyzer. This means the test cannot be used on other immunoassay platforms, and laboratories must have this specific analyzer to run it. The analyzer’s compatibility ensures consistent results and proper calibration, which is critical for accurate diagnosis of parvovirus B19 exposure or fifth disease.
What is the purpose of the paired control (LIAISON Biotrin Control Parvovirus B19 IgG Plus) included with this assay, and how does it enhance reliability?
The paired control serves as a quality assurance measure to verify the performance of the LIAISON Biotrin Parvovirus B19 IgG Plus assay before running patient samples. It helps ensure the test is functioning correctly, reducing the risk of false positives or negatives due to equipment malfunctions, reagent degradation, or procedural errors. This is particularly important in clinical settings where accurate results directly impact patient management, such as in diagnosing parvovirus B19 infections or assessing maternal-fetal risks.
How should the LIAISON Biotrin Parvovirus B19 IgG Plus be stored, and does it require any special handling beyond standard immunoassay protocols?
The device follows standard immunoassay storage and handling protocols, meaning it should be stored according to the manufacturer’s instructions provided with the kit (typically refrigerated or at room temperature, depending on the specific lot). No additional sterility or MRI safety considerations apply, as it is intended for laboratory use only and is not implanted or exposed to magnetic fields. Proper storage ensures the assay’s reagents remain stable and reliable for accurate testing.
What is the intended clinical use of this assay, and why is it particularly relevant for certain patient populations?
The assay is intended for **qualitative detection of IgG antibodies** to parvovirus B19 in patients, aiding in diagnosing fifth disease (erythema infectiosum) and assessing exposure risk—especially in women of childbearing age. This is clinically relevant because parvovirus B19 infections during pregnancy can pose risks to fetal health, such as hydrops fetalis or miscarriage. The test helps clinicians identify prior exposure (via IgG presence) or active infection (via IgM, if available), guiding preventive or supportive care decisions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Parvovirus Diagnostics Solutions | Immunodiagnostics - DiaSorin, LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control ..., PDF LIAISON Biotrin Control Parvovirus B19 IgG Plus, PDF LIAISON® Biotrin Parvovirus B19 IgG Plus (REF 311540)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P220034 | Class III | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P220034 24 fields · synced Sep 18, 2026