Search Results

The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

The test system consists of BIOCHIPs coated with HEp-20-10 cells. It includes a fluorescein-labeled goat anti-human IgG, a positive and negative control, salt for PBS, Tween 20, embedding medium, cover glasses and instruction booklet. Reagent trays for the TITERPLANE technique are required but ordered separately.

Here's a breakdown of the acceptance criteria and study information for the EUROIMMUN IFA 40: HEp-20-10 device, based on the provided text:

Acceptance Criteria and Device Performance

Ask a specific question about this device

The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.

This device is an aid to the diagnosis of SSc. Systemic sclerosis (SSc) is an autoimmune disease characterized by microvascular damage and fibrosis of the skin and internal organs. RNA polymerase(RNAP) I, II and III are major targets of autoantibody responses in SSc patients. Each RNAP catalyzes transcription of unique sets of genes: RNAP I transcribes ribosomal RNA genes, RNAP II transcribes all protein coding genes and several small nuclear RNA genes, and RNAP III transcribes genes that produce small stable RNAs including 5S and transfer RNAs. Anti-RNAP I and anti-RNAP III antibodies are almost always present together (anti-RNAP I/II), and some sera contain anti-RNAP II antibody as well. Anti-RNAP I/II antibodies are the most common SSc related antibodies in white North American patients with SSc and is associated with diffuse cutaneous involvement, a high frequency of "renal crisis", and high mortality. In addition, it has been shown that some SSc sera contain autoantibodies recognizing RNAP II but not RNAP I or III. Antibodies to RNAP II are also present in sera from some patients with systemic lupus erythematosus (SLE) or overlap syndrome. PRINCIPLE: The anti-RNA Polymerase III ELISA Kit measures anti-RNAP III antibodies present in the serum by ELISA. Diluted Calibrators and patient serum are added to microwell coated with RNAP III antigens, allowing anti-RNAP III antibodies to react with the immobilized antigen (Sample incubation). After washing to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG is added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.

The provided text doesn't contain specific acceptance criteria with quantifiable metrics (e.g., sensitivity, specificity thresholds) or a detailed study description with performance metrics for the MBL Anti-RNA Polymerase III ELISA Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices based on general characteristics and clinical utility.

However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices and the performance characteristics established by comparison with a research method (Immunoprecipitation).

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

• Sample Size: The document does not specify the sample size used for the clinical trial or test set. It only mentions "clinical trial."
• Data Provenance: The document does not state the country of origin of the data or whether it was retrospective or prospective. It just refers to "clinical and non-clinical testing data."

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided.

4. Adjudication Method for the Test Set

This information is not provided.

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

• The document does not indicate that an MRMC comparative effectiveness study was done.
• It refers to "comparison with a research method, Immunoprecipitation, AND K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM." This suggests a direct comparison of the device's results against a gold standard/reference method and a predicate device, rather than an evaluation of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance assessment was done. The entire premise of an ELISA kit is to provide a diagnostic result from the assay itself. The "clinical trial via comparison with a research method, Immunoprecipitation" directly evaluates the performance of the kit (the "algorithm only") against a known reference. There is no human-in-the-loop component mentioned for interpreting the ELISA results beyond standard laboratory practices.

7. Type of Ground Truth Used

• The primary ground truth used for performance validation was a research method, Immunoprecipitation. This is commonly considered a highly specific and sensitive "gold standard" for detecting autoantibodies in research and some clinical settings.
• Additionally, comparison was made against K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, which is an indirect fluorescent antibody test for antinuclear antibodies, likely serving as another comparator or a secondary form of reference for general ANA detection, although Immunoprecipitation is the more specific reference for anti-RNA Polymerase III.

8. Sample Size for the Training Set

• The document does not specify a training set size. This is common for traditional in-vitro diagnostic kits like ELISA, where algorithms are not "trained" in the machine learning sense. The kit's performance characteristics are inherent to its biochemical design and manufacturing, and validated through clinical trials, without a distinct "training set" of patient data for algorithm development.

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

• As there's no mention of a "training set" in the context of an algorithm, there's no information on how its ground truth was established. The development of the ELISA kit (e.g., choice of antigens, antibodies, assay conditions) would be based on scientific understanding of anti-RNA Polymerase III antibodies and their detection, rather than an iterative training process with labeled data. The validation (test set) uses Immunoprecipitation as the ground truth.

Ask a specific question about this device

This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

This is an enzyme immunoassay for the detection of antinuclear antibodies in human serum.

This document describes the RELISA® ANA Screening Test System, an enzyme immunoassay for the detection of antinuclear antibodies in human serum, intended as an aid in detecting antibodies associated with systemic rheumatic disease.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion appears to be "overall agreement" with a reference method. The initial comparison to the predicate device set the stage, but a "referee method" (Immuno Concepts HEp-2000® ANA-Ro Test System using indirect fluorescent antibody technique) was ultimately used to clarify "false positive" and "false negative" results.

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

• Sample Size:
  • Initial Comparison (with Predicate device): 214 (Positive) + 46 (Predicate Negative/Test Positive) + 12 (Predicate Positive/Test Borderline) + 105 (Predicate Negative/Test Borderline) + 8 (Predicate Positive/Test Negative) + 787 (Negative) = 1172 samples.
  • Revised Comparison (with Referee Method): The number of samples re-evaluated for the "referee method" was 79 "false positive" (from the initial comparison) and 4 "false negative" samples. The table provided for the revised comparison then summarizes the results for the entire cohort of 1172 samples based on the referee method's classification for the previously discrepant cases.
• Data Provenance: Not explicitly stated, but given context of the submission, it is assumed to be retrospective clinical samples. No country of origin is mentioned.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The ground truth for the referee method involved use of the "indirect fluorescent antibody technique" and observation of "clearly discernible ANA patterns." This strongly implies interpretation by trained laboratory professionals, likely medical technologists or clinical immunologists with expertise in ANA testing. Specific qualifications (e.g., years of experience, board certification) are not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: The document describes a specific process for adjudication of discrepant results: "The large number of 'false positive' samples seen with the Immuno Concepts test was troubling, so we tested all of these sera for antinuclear antibodies using Immuno Concepts HEp-2000® ANA-Ro Test System (K944096 & K972145)." This indicates a targeted re-evaluation of initially discrepant samples using a more definitive "referee method" (indirect fluorescent antibody technique), where the results of this referee method were then considered the "true" classification. This is a form of discrepancy resolution with a gold standard.

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

• There is no indication of an MRMC comparative effectiveness study being performed. The study focuses on comparing the new device against a predicate device and a "referee method," not on human reader performance with or without AI assistance.

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

• Yes, a standalone performance study was conducted. The RELISA® ANA Screening Test System is an enzyme immunoassay, and its performance was evaluated directly against other laboratory tests (the predicate device and the indirect fluorescent antibody technique) without explicit human intervention in the interpretation of the RELISA results for the purpose of the study. The results are from the device itself.

7. The Type of Ground Truth Used:

• The initial comparison used the predicate device's results as a reference.
• The refined comparison, which led to the final performance metrics, used the indirect fluorescent antibody technique (IFA) performed with the Immuno Concepts HEp-2000® ANA-Ro Test System as the "referee method" or gold standard for establishing ground truth, especially for discrepant samples. IFA is generally considered a highly sensitive and specific method for ANA detection and pattern recognition, often serving as a reference method in clinical immunology.

8. The Sample Size for the Training Set:

• The document does not explicitly mention a separate training set or its sample size. This type of submission for an in vitro diagnostic (IVD) device typically focuses on clinical validation (test set) for regulatory approval rather than machine learning model training.

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

• As no training set is explicitly described, there is no information provided on how its ground truth might have been established.

Ask a specific question about this device