Search Results

The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 mm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

For In Vitro Diagnostic Use.

The IT / IF Control is designed to qualitative detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods :

• Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP instrument,

• Immunofixation methods : SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.

The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.

The electrophoretic pattern obtained is specific for each batch of IT / IF control.

For In Vitro Diagnostic Use.

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in liquid solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses.

In CAPI 3 MMUNUOTYPING kit contains the sample diluent and specific antisera against gamma (Ig G), alpha (Ig A), mu (Ig M) heavy chains, and free and bound Kappa and Lambda light chains. A sample dilution is prepared and injected at the anodic end of six capillaries. The reference pattern (ELP pattern), which is a complete electrophoretic pattern of the sample's proteins, is obtained by mixing the sample with the ELP solution and injection into the 1st capillary. The antisera patterns are obtained by sample aspiration into the 5 subsequent capillaries separation is performed in a high voltage electrical field and detected using absorbance at 200 nm.

The IT / IF control contains three monoclonal proteins which can be used as a qualitative control with the CAPI IMMUNOTYPING kit on the CAPILLARYS 3 TERA instrument.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table. However, the method comparison study provides the performance benchmark against the predicate device.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Method Comparison (Test Set): 115 serum samples (12 normal, 103 pathological).
• Data Provenance: Not explicitly stated as country of origin. The manufacturing information (Sebia, FRANCE) implies the device developer is French, but the source of the samples is not provided. The study is retrospective as it compares results from existing clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth. The comparison is made against a "predicate device" (CAPILLARYS IMMUNOTYPING procedure), which implies the predicate device's results are considered the reference or "ground truth" for this study. The visual evaluation of electrophoregrams is mentioned, which typically involves trained laboratory personnel or pathologists, but specifics are missing.

4. Adjudication Method

Not explicitly stated. The study reports 100% agreement, suggesting no significant discrepancies arose that would require an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done based on the provided text. The study compares the device's performance to a predicate device, not human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the method comparison study appears to be a standalone performance evaluation of the CAPI 3 IMMUNOTYPING procedure (algorithm + instrument system) against the predicate device's procedure. While the "electrophoregrams are evaluated visually," the 100% agreement is attributed to the techniques rather than individual human interpretations.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the results obtained from the predicate device (CAPILLARYS IMMUNOTYPING procedure). This means the predicate device's ability to detect and characterize monoclonal proteins served as the reference standard.

8. The Sample Size for the Training Set

The document does not mention a training set nor does it explicitly describe an AI/machine learning component that would require a distinct training set. The device appears to be a diagnostic instrument based on capillary electrophoresis, not an AI-driven interpretation tool.

9. How the Ground Truth for the Training Set Was Established

Since no training set or AI component is described, this information is not applicable.

Ask a specific question about this device