(185 days)
The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test İs intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is a colloidal gold/antibody conjugatebased immunoassay designed for the detection of cTnl in human whole blood, plasma and serum samples. To perform the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test, the sample is dispensed into the sample well. The red cells in the whole blood will react with certain biochemical reagents (such as anti-red blood cells) which are immobilized in the sample pad. This reaction will cause the red blood cells to bind to the sample pad, allowing only the plasma to travel forward. CTnl that is present in the specimen is bound by a gold-antibody conjugate forming a gold-antibody-antigen complex. This complex migrates across the membrane by capillary action and reacts with three anticTnl monoclonal antibodies immobilized in the test region to produce a pink color band when the cTnl concentration is equal to or greater than 1.5 ng/ml. If cTnl is not present in the specimen, there is no line in the test line area. The mixture continues to migrate to the procedural control line area and produce a pink color band. If no procedural control line is present, the sample is invalid and should be retested.
This document describes the test performance characteristics of the BioCheck Whole Blood/Plasma/Serum cTnI Rapid Test. Here's a breakdown of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with predefined targets. Instead, it presents various test performances which implicitly serve as the criteria the device met.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (Between Runs - Serum) | 100% agreement | 100% agreement between runs and between four testing sites |
| Precision (Between Runs - Whole Blood) | 100% agreement | 100% agreement between runs and between four testing sites |
| Recovery Study (Serum) | 100% agreement | 100% agreement between expected and observed results at each cTnI concentration |
| Recovery Study (Whole Blood) | 100% agreement | 100% agreement between expected and observed results at each cTnI concentration |
| Interference (Various analytes & drugs) | No interference up to specified levels | No interference observed at the indicated test levels for all listed analytes and drugs |
| Clinical Correlation (Serum samples vs. ELISA) | High Sensitivity, Specificity, and Accuracy | Sensitivity = 97.3%, Specificity = 97.1%, Overall Accuracy = 97.1% |
| Correlation (Whole Blood vs. Plasma) | 100% agreement | 100% agreement (68/68 samples) |
| Clinical Studies (Confirmed MI - Whole Blood) | High agreement with patient status | 95.8% agreement (23/24 samples) with confirmed MI status |
| Clinical Studies (Non-MI - Whole Blood) | 100% agreement with patient status | 100% agreement (44/44 samples) with non-MI status |
| Correlation (Whole Blood vs. Serum - Spiked Samples) | 100% agreement | 100% agreement between whole blood and serum spiked samples |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision (Serum & Whole Blood):
- Each of 4 labs tested 5 blind replicates of 3 different cTnI concentrations (0, 1.5, 3.0 ng/ml).
- Total tests per site = 15. Total over 4 sites = 60. Manufacturer's lab also tested.
- Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. and collaborating labs. Retrospective from spiked samples.
- Recovery Study (Serum & Whole Blood):
- 6 replicates for each of 5 cTnI concentrations (0, 0.5, 1.0, 1.5, 3.0 ng/ml).
- Total replicates per sample type = 30. Total for both serum and whole blood = 60.
- Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. Retrospective from spiked samples.
- Interference:
- Amount not specified, but various analytes and drugs were tested at specified concentrations.
- Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. Retrospective from spiked samples.
- Clinical Correlation (Serum):
- Test Set Size: 245 patient serum samples.
- Data Provenance: Not explicitly stated, but implies patient samples, likely retrospective. Country of origin not specified.
- Correlation (Whole Blood vs. Plasma):
- Test Set Size: 68 paired whole blood and plasma samples from patients.
- Data Provenance: Patient samples, likely retrospective. Country of origin not specified.
- Clinical Studies (Confirmed MI Patients - Whole Blood):
- Test Set Size: 24 whole blood specimens from confirmed MI patients.
- Data Provenance: Patient samples, likely retrospective. Country of origin not specified.
- Clinical Studies (Non-MI Patients - Whole Blood):
- Test Set Size: 44 whole blood specimens from non-MI patients.
- Data Provenance: Patient samples, likely retrospective. Country of origin not specified.
- Correlation (Whole Blood vs. Serum - Spiked Samples):
- Test Set Size: 20 individuals provided paired whole blood and serum samples, spiked with cTnI.
- Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. Retrospective from spiked samples.
3. Number of Experts and Qualifications for Ground Truth:
- For the Clinical Correlation Study and Clinical Studies (confirmed MI and non-MI patients), the reference method for confirming cTnI levels was a "commercially available quantitative ELISA assay for cTnI" and the "BioCheck cTnI ELISA Test."
- For the "Confirmed MI Patients" and "Non-MI Patients" studies, the ground truth refers to "patient status" as confirmed MI or non-MI. This implies clinical diagnosis, likely involving medical professionals, but the number and qualifications of these experts are not specified in the document. The ELISA assay serves as the reference for the cTnI concentration in these studies.
4. Adjudication Method for the Test Set:
- The document describes comparisons to existing methods (ELISA for cTnI, clinical status for MI). There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth or resolving discrepancies in any of the studies. The reference methods are assumed to be definitive.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test for qualitative determination of cTnI, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. Standalone Performance:
- Yes, standalone performance was done. All the reported performance metrics (precision, recovery, interference, clinical correlation, and clinical studies) assess the performance of the BioCheck Whole Blood/Plasma/Serum cTnI Rapid Test on its own, without human-in-the-loop assistance. It is designed to provide a direct qualitative result.
7. Type of Ground Truth Used:
- Expert Consensus / Reference Assay and Clinical Outcomes:
- For assays confirming cTnI levels, the ground truth was established by comparison to a commercially available quantitative ELISA assay for cTnI (implicitly considered a gold standard for cTnI concentration).
- For the "Clinical Studies" on confirmed MI and non-MI patients, the ground truth for patient status was based on clinical diagnosis ("confirmed MI patients" and "non-MI patients"), likely supported by the ELISA results, which falls under clinical outcomes/diagnosis, implicitly representing expert medical consensus.
- For spiked samples, the ground truth was the known, introduced concentration of cTnI.
8. Sample Size for the Training Set:
- The document does not mention a training set or indicate that the device used machine learning or AI algorithms requiring a training set. This is a traditional immunoassay. The studies described are validation and performance testing, not model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for this device.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.