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Immunoturbidometric assay for the quantitative in-vitro determination of Prealbumin.

Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma.

Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

The Prealbumin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Prealbumin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Prealbumin antibodies (R₂ reagent) is added to mixture of the first step. The antibody binds to the Prealbumin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of Prealbumin present in the sample.

The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Prealbumin in the sample is directly proportional to the amount of turbidity formed.

Here's a breakdown of the acceptance criteria and study information for the Boehringer Mannheim Tina-quant® Prealbumin Assay, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" with pass/fail thresholds. Instead, it presents performance characteristics for the Tina-quant® Prealbumin assay and compares them to a predicate device (Behring BN® Prealbumin assay) to demonstrate substantial equivalence. The implication is that the Tina-quant® assay's performance should be comparable to or better than the predicate.

Here's a table summarizing the reported device performance:

Study Details

Based on the provided text, the document describes the performance characteristics of the device rather than a single, named "study." The data presented are likely derived from various validation experiments detailed in Attachment 6 (which is not provided in this extract).

1. Sample size used for the test set and the data provenance:

   • Precision (Intra-Assay): N=21 for each of the three levels tested.
   • Precision (Inter-Assay): N=21 for each of the two samples tested.
   • Method Comparison: N=102 samples used for comparison against the Behring BN® Prealbumin.
   • Method Comparison (Vs NDR Parigen® Prealbumin): N=40 samples.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It is implied to be laboratory-derived data for performance validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. For this type of in-vitro diagnostic device (immunoturbidometric assay), "ground truth" is established by the reference method or comparison method itself (e.g., the Behring BN® Prealbumin assay or NDR Parigen® Prealbumin). Expert consensus for image interpretation, for example, is not relevant here.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative immunoassay, not a qualitative assessment requiring adjudication.

4. 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 is an in-vitro diagnostic assay, not an AI-assisted diagnostic imaging device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is a standalone assay. Its performance characteristics are measured directly, without human interpretation as part of the primary measurement output. The device itself (Tina-quant® Prealbumin Assay run on a Hitachi instrument) is the "standalone" entity producing quantitative results.

6. The type of ground truth used:

   • For method comparison, the "ground truth" is considered to be the results obtained from the predicate device (Behring BN® Prealbumin assay) or another established method (NDR Parigen® Prealbumin). For precision, the "truth" is the inherent variability of the assay itself. For interfering substances, the "truth" is that known concentrations of interferents do not significantly impact the result.

7. The sample size for the training set:

   • Not explicitly stated. For a traditional immunoassay, there isn't a "training set" in the machine learning sense. The assay is developed and optimized, then validated with test samples. The data provided are from the validation phase.

8. How the ground truth for the training set was established:

   • Not applicable as there is no "training set" in the machine learning context for this device. The development of such assays involves optimizing reagents and reaction conditions against known standards and reference methods to achieve accurate and precise measurements.

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