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Lumipulse G TSH-III Immunoreaction Cartridges
For in vitro diagnostic use. Lumipulse G TSH-III is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulation hormone (TSH) in human serum on the LUMIPULSE G System. Lumipulse GTSHIII is to be used as an aid in the diagnosis of thyroid or pituitary disorders.
Lumipulse GTSH-III is an assay system, including a set of immunoassay reagents, for the quantitative measurement of TSH in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. TSH in specimens specifically binds to anti-human TSH monoclonal antibody (mouse) on the particles, and antigen-antibody immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP: calf)-labeled anti-human TSH monoclonal antibody (mouse) specifically binds to TSH of the immunocomplexes on the particles, and additional immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Substrate Solution is added and mixed with the particles. AMPPD contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of dephosphorylated AMPPD. The luminescent signal reflects the amount of TSH.
The Lumipulse® G TSH-III Immunoreaction Cartridges is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum on the LUMIPULSE G System. It is intended for in vitro diagnostic use, as an aid in the diagnosis of thyroid or pituitary disorders.
The study presented focuses on demonstrating the analytical performance and method comparison of the Lumipulse G TSH-III assay against the predicate device, Abbott ARCHITECT TSH assay, to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from study results and CLSI guidelines) | Reported Device Performance (Lumipulse G TSH-III) |
|---|---|---|
| Precision/Reproducibility | ||
| Within-Laboratory (Total) Precision (20-Day) | ≤ 6.4% CV (as demonstrated by predicate and industry standards) | ≤ 6.4% CV (range 1.9% - 6.4% across 5 panels) |
| Lot-to-Lot Reproducibility (Total Precision) | ≤ 4.6% CV (as demonstrated) | ≤ 4.6% CV (range 3.1% - 4.6% across 3 panels) |
| Between-Lot Precision | ≤ 4.0% CV (as demonstrated) | ≤ 4.0% CV |
| Site-to-Site Reproducibility (Total Precision) | ≤ 4.3% CV (as demonstrated) | ≤ 4.3% CV (range 2.9% - 4.3% across 3 panels) |
| Between-Site Precision | ≤ 2.4% CV (as demonstrated) | ≤ 2.4% CV |
| Linearity/Assay Reportable Range | Linear correlation (R-squared close to 1) over a wide range; no high dose hook effect | Linear in the range of 0.001 to 227.804 µIU/mL (y = 1.03x + 0.001; R-squared: 0.9962); No high dose hook effect observed up to ~5,000 µIU/mL |
| Detection Limits | ||
| Limit of Blank (LoB) | Low as possible for diagnostic utility (consistent with CLSI EP17-A2) | 0.0010 µIU/mL |
| Limit of Detection (LoD) | Low as possible for diagnostic utility (consistent with CLSI EP17-A2) | 0.002 µIU/mL |
| Limit of Quantitation (LoQ)/Functional Sensitivity (FS) | ≤ 0.02 µIU/mL for third-generation TSH assays (NACB Guideline) | ≤ 0.006 µIU/mL |
| Analytical Specificity (Interference) | Average interference ≤ 10% for each compound | ≤ 10% interference for tested endogenous and therapeutic drug compounds |
| Method Comparison (vs. Abbott ARCHITECT TSH) | High correlation coefficient (r) and acceptable slope/intercept relative to predicate | n=141; r = 0.9838; Intercept = -0.0037 (95% CI: -0.0064 to -0.0010); Slope = 0.97 (95% CI: 0.93 to 1.01); Average Bias = -1.051 µIU/mL |
2. Sample Size for the Test Set and Data Provenance
- Precision/Reproducibility (20-Day): 5 human serum-based panels, assayed in replicates of two at two separate times of the day for 20 days (n=80 for each sample). The origin of these human serum-based panels is not explicitly stated regarding country or retrospective/prospective nature, but they are described as "human serum-based panels."
- Lot-to-Lot Reproducibility: 3 panels, specific sample size (replicates/days) not explicitly stated but part of a larger precision analysis.
- Site-to-Site Reproducibility: 3 panels (Lot A), specific sample size (replicates/days) not explicitly stated but part of a larger precision analysis.
- Linearity/Assay Reportable Range: High and low sample pools, number of samples not explicitly stated beyond "patient samples."
- Detection Limit (LoB & LoD): Eight low-level specimens tested over 6 weeks using two LUMIPULSE G1200 Systems and two Lumipulse G TSH-III lots, giving 480 determinations for each panel.
- Analytical Specificity: Human serum specimens with TSH concentrations of approximately 0.566, 2.530, and 67.515 ulU/mL, supplemented with potentially interfering compounds.
- Cross-reactivity: Human serum specimens with TSH concentrations of approximately 0.566, 2.530, and 67.515 µIU/mL, supplemented with potentially cross-reacting compounds (n=3 for each test concentration).
- Method Comparison: 141 serum samples, ranging from 0.026 to 84.299 µIU/mL (Lumipulse G TSH-III) and 0.030 to 89.930 µIU/mL (ARCHITECT TSH). The provenance (e.g., country of origin, retrospective/prospective) of these samples is not specified beyond being "patient samples."
- Expected values/Reference range: 116 healthy test subjects. Provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of immunoassay performance study typically does not involve human expert adjudication for ground truth of individual measurements in the same way imaging or diagnostic accuracy studies might. The "ground truth" for the performance characteristics (precision, linearity, detection limits, specificity) is based on the inherent analytical properties of the reference materials, calibrated instruments, and statistical methodologies (e.g., CLSI protocols). For the method comparison, the predicate device (Abbott ARCHITECT TSH) serves as the comparator, and its established performance is implicitly relied upon.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense. The "ground truth" for analytical performance is derived from well-defined reference materials, established concentrations, and statistical analyses following recognized CLSI protocols. For method comparison, the reference measurements from the predicate device serve as the comparison point.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not an imaging or diagnostic aid that involves human readers interpreting cases with or without AI assistance. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was done. All performance characteristics (precision, linearity, detection limits, analytical specificity, and method comparison) evaluate the Lumipulse G TSH-III assay's performance as a standalone algorithm/device. The results reported are direct measurements from the LUMIPULSE G System.
7. Type of Ground Truth Used
- Precision/Reproducibility: Based on repeated measurements of samples with established concentrations, and statistical analysis of variability.
- Linearity/Assay Reportable Range: Established using prepared high and low sample pools with known TSH concentrations and assessed by linear regression analysis.
- Detection Limits (LoB, LoD, LoQ/FS): Determined statistically from measurements of very low concentration samples according to CLSI guidelines.
- Analytical Specificity/Cross-reactivity: Determined by measuring samples spiked with known concentrations of interfering or cross-reacting substances.
- Method Comparison: Compared against the measurements obtained from a legally marketed predicate device (Abbott ARCHITECT TSH), which itself has established performance characteristics.
- Traceability of Calibrators: Traceable to the 3rd International Standard, 2003 (code: 81/565) by the National Institute for Biological Standards and Control (NIBSC).
8. Sample Size for the Training Set
The document describes performance studies, which are typically validation studies. It does not explicitly mention a "training set" in the context of an AI/machine learning model. For a traditional immunoassay, the "training" aspect is more akin to the assay development and optimization process, not a distinct dataset used for machine learning. The calibrators and controls are used for instrument calibration and assay quality control, not as a training set for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of an AI training set. For an immunoassay, the "ground truth" for calibrators and controls is established through gravimetric preparation and traceability to international standards (e.g., NIBSC 3rd International Standard for TSH).
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