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The Bartels CINAkit™ CMV Antigenemia Test is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the rapid direct qualitative detection of CMV pp65 antigen in human blood leukocytes by indirect immunofluorescence (IF). This product is not intended to be used for testing (i.e. screening) blood or plasma donors.

BARTELS CINAKIT CMV Antigenemia is an indirect immunofluorescence test that allows detection of Human Cytomegalovirus antigen in leukocytes from peripheral blood. The test uses a monoclonal antibody pool (1C3, AYM-1) which recognizes the 65-68kDa lower matrix structural phosphoprotein (pp) (protein kinase, pp65, present in the nucleus of cells. The antibody pool (blended antibodies) recognizes two epitopes on the protein. Leukocytes are prepared from whole blood by dextran sedimentation and centrifugation; slides are prepared, fixed in formalin and permeabilized on detergent (NP40). Staining is accomplished with primary murine monoclonal antibodies to the pp65 antigen and F(Ab-)2 fluorescein-conjugated anti-mouse immunoglobulin secondary antibody. The slides are read using a fluorescence microscope.

This document describes the Bartels CINAkit CMV Antigenemia test, an immunoassay for the detection of CMV.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, the BIOTEST CMV BRITE TEST Kit. The performance characteristics of both devices are directly compared.

Note: The reported device performance for Bartels CINAkit CMV Antigenemia is presented in two places:

1. In Table 1, where it lists "Sensitivity: 82.86%, Specificity: 88.67%, Accuracy: 88.06%".
2. In the "Performance Characteristics 2." section, based on the clinical study, where it details "Sensitivity = 29/35 = 83% (95% Confidence interval = 70.4 - 95.3%)" and "Specificity = 266/300 = 89% (95% Confidence interval = 85.1 - 92.3%)". For the purpose of this table, the values from the clinical study are generally considered the primary performance claims. The values in Table 1 might represent initial expectations or a summary, but the detailed clinical study data provides the specific numbers that are directly supported.

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

• Sample Size: 335 clinical specimens.
• Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical specimens" and a "clinical study" but does not specify if it was retrospective or prospective. Given the nature of medical device submissions, it's typically a prospective collection of real-world samples to validate performance, but this is not explicitly stated.

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

The ground truth was established by a "culture method," referred to as the "gold standard." This typically implies laboratory testing and interpretation by trained microbiologists or laboratory technicians rather than clinical experts (e.g., radiologists) in the context of imaging. The document does not specify the number of experts or their qualifications for interpreting the culture results.

4. Adjudication Method

Not applicable. The ground truth was established by a "gold standard" culture method, not through adjudication of expert opinions on the test specimens themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This is a diagnostic kit for laboratory use, not typically a device that involves multiple human readers interpreting images against an AI. The "comparison" mentioned is between the Bartels CINAkit and "Other CMV" (the predicate device) in terms of their performance against a gold standard, not a human-in-the-loop study with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was clearly done. The Bartels CINAkit CMV Antigenemia device was evaluated by comparing its results against the "gold standard" culture method on 335 clinical specimens. The reported sensitivity and specificity are for the algorithm (kit) acting alone, without overt human-in-the-loop assistance for interpretation. The interpretation of the immunofluorescence slides by a fluorescence microscope would still involve a human reading the results of the kit-prepared slides.

7. Type of Ground Truth Used

Expert Consensus, Pathology, or Outcomes Data: The type of ground truth used was the culture method, which is explicitly stated as the "gold standard." This implies a microbiology laboratory culture result, which is considered highly reliable for detecting viral presence.

8. Sample Size for the Training Set

The document does not provide information about a separate training set. It describes a single "clinical study" involving 335 specimens for performance evaluation. For immunoassay kits like this, the development process might involve internal validation and optimization, but a distinct "training set" in the context of machine learning is not applicable here.

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

As there is no distinct "training set" described in the context of a machine learning-based device, this question is not applicable. The performance evaluation study used the culture method as the gold standard for its 335 specimens.

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