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The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The Trinidad IM system's assay applications utilize chemiluminescent technology for clinical use.

The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Trinidad IM system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Trinidad IM TSH Calibrators are for in vitro diagnostic use in calibrating the Trinidad IM system TSH assay.

The Siemens Healthcare Diagnostics Trinidad Immunoassay (IM) system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software.

The Trinidad IM TSH assay reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
500 Test Kit:

• 5 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, Solid Phase, and Ancillary Reagent
• 2 vials of lyophilized Trinidad IM TSH low calibrator
• 2 vials of lyophilized Trinidad IM TSH high calibrator

100 Test Kit:

• 1 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, Solid Phase, and Ancillary Reagent
• 1 vial of lyophilized Trinidad IM TSH low calibrator
• 1 vial of lyophilized Trinidad IM TSH high calibrator

The ReadyPack consists of the following:

• Lite Reagent 6.0 mL/ reagent pack: The Lite Reagent contains bovine serum albumin (BSA) conjugated to murine monoclonal anti-TSH (~0.3 µg/mL) antibody labeled with acridinium ester, buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
• Solid Phase Reagent 21.0 mL/ reagent pack: The Solid Phase reagent contains anti-fluorescein murine monoclonal antibody covalently linked to paramagnetic particles (~85 µg/mL), buffer, stabilizers (bovine, caprine proteins), surfactant, and preservatives.
• Ancillary Reagent 6.0 mL/ reagent pack: The Ancillary reagent contains FITC conjugated to murine monoclonal anti-TSH antibody (~3 µg/mL), buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.

The TSH Calibrator consists of the following:

• After reconstitution, low and high levels of thyroid stimulating hormone (TSH) in HEPES buffered equine serum with sodium azide (< 0.1%) and preservatives. The low and high calibrators are targeted at ~ 0.032 and 97.5 µIU/mL, respectively.

Here's a breakdown of the acceptance criteria and the study details for the Trinidad IM Thyroid Stimulating Hormone (TSH) assay, Trinidad Immunoassay (IM) system, and Trinidad IM TSH Calibrators, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Detection Limits:
  • LoB: 10 times in each of at least 10 runs using 1 lot of reagent on 2 systems over a period of at least 5 days (n = 200).
  • LoD: Low level TSH serum samples assayed in duplicate in each of at least 20 runs using 1 lot of reagents on 2 systems over a period of at least 10 days (n=80).
  • LoQ: Multiple patient samples with low TSH values assayed in duplicate in each of 10 runs on 2 systems over a period of 10 days. (Specific n not given, but many samples implied).
• Linearity: Nine (9) equally spaced pools, ranging in TSH levels from 0.0001 to 151 ulU/mL, prepared from a high TSH serum sample mixed with an equine serum pool.
• Precision: Four commercial controls, six serum samples, and six plasma samples. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days. (Total of 80 replicates per sample tested).
• Interfering Substances: Specific number of samples not provided, but tested with various levels of hemolyzed, lipemic, and icteric specimens.
• Cross-reactivity: Human samples containing TSH, with added hCG, FSH, and LH. Specific number of samples not provided.
• High Dose Hook Effect: Serial dilutions of a very high TSH sample. Specific number of samples not provided.
• Method Comparison: Sample Range of 0.008 – 148.8 µIU/mL. (Exact number of samples not provided).
• Serum Plasma Matrix Equivalency: Sample Range of 0.014 – 134.5 µIU/mL for both lithium heparin and EDTA plasma vs. serum. (Exact number of samples not provided).
• Expected Values:
  • Infants (01 - 23 months): N = 46
  • Children (02 - 12 years): N = 136
  • Adolescents (13 - 20 years): N = 160
  • Adults (≥ 21 years): N = 155

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "human serum and plasma" samples and "patient samples," suggesting clinical samples were used.

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

This type of immunoassay device measures a quantitative biomarker. The "ground truth" for each sample is typically the concentration of TSH in that sample, as measured by a highly accurate and precise reference method or an existing, validated device. Therefore, the concept of "experts" to establish ground truth in the way it's used for AI image analysis (e.g., radiologists interpreting images) is not directly applicable here. The ground truth for method comparison studies is the measurement from the predicate device (ADVIA Centaur TSH3 Ultra assay).

4. Adjudication Method for the Test Set:

Not applicable in the context of quantitative laboratory assays. The "ground truth" values are instrumental measurements, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret cases, and the AI's effect on their performance is evaluated. For this TSH assay, the comparison is directly between the new device's readings and a predicate device's readings.

6. Standalone Performance:

Yes, a standalone performance was done. All the performance characteristics listed (detection limits, linearity, precision, interference, cross-reactivity, high dose hook effect, serum plasma matrix equivalency, expected values, stability) evaluate the algorithm's performance independent of human intervention once the sample is loaded into the automated system. The "method comparison" also compares the new device's standalone measurements directly against those of the predicate device.

7. Type of Ground Truth Used:

• Quantitative measurements: For most performance characteristics, the ground truth is implicitly defined by highly accurate and precise laboratory methods or reference materials.
• Predicate device measurements: For the method comparison study, the "ground truth" against which the new device's performance was compared was the measurements obtained from the legally marketed ADVIA Centaur TSH3 Ultra assay.

8. Sample Size for the Training Set:

This document does not specify a separate "training set" in the context of machine learning. For traditional immunoassay development, methods are developed and validated using various samples to establish performance characteristics. The document describes several testing phases:

• Detection Limits, Linearity, Precision, Interference, Cross-reactivity, High Dose Hook Effect: These involve testing across various samples and conditions to characterize the assay's fundamental performance.
• Expected Values: Human populations are tested (Infants N=46, Children N=136, Adolescents N=160, Adults N=155) to establish reference ranges.
• Method Comparison: Samples covering a range from 0.008 – 148.8 µIU/mL were used for comparison against the predicate.

While these tests inform the overall validation, they are not typically referred to as "training sets" in the AI sense. The assay principle is a fixed chemical reaction, not a machine learning model that "learns" from data.

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

As there isn't a traditional "training set" for a machine learning algorithm, this question isn't directly applicable. For the performance characteristics, the "ground truth" is established as follows:

• Reference Methods/Materials: For limits and linearity, the "true" concentrations are often derived from highly controlled preparations or validated reference materials.
• Predicate Device: For method comparison, the results from the previously cleared predicate device (ADVIA Centaur TSH3 Ultra assay) serve as the comparative "ground truth."
• Standardization to WHO International Standard: The TSH assay and calibrators are stated to be traceable to the World Health Organization (WHO) 3rd International standard for human TSH (IRP 81/565), which acts as a primary ground truth for TSH measurement comparability.

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