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The AquaLite® LH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® LH assay) is intended to be used for the quantitative determination of human LH in sera and plasma. The AquaLite® LH assay is for in vitro diagnostic use.

The AquaLite® LH Bioluminescent Immunoassay Kit uses a polyclonal anti-LH aitibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma and appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. Anti-LH Conjugate (150uL) is then added to the tubes. The conjugate uses the photoprotein, AquaLite® (recombinant aequorin; Patent Nos. 5, 422, 266 and 5, 486, 455 which is covalently linked to an anti-LH monoclonal antibody. LH in the sample simultaneously combines with polyclonal antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 60-minute incubation period at room temperature (18°C to 25°C) on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.

The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. An injected calcium trigger solution causes AquaLite® to oxide its self-contained luciferin molecule. This reaction produces a flash of light at 469 nm, which is measured by the luminometer. The intensity of the light is directly proportional to the concentration of the LH in the sample. To calculate results, the light intensity (in relative light units. RLU) of the LH calibrators is plotted against LH concentration (in International Units per liter, IU/L) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to LH concentration in IU/L. Note that the numerical value for LH in mIU/mL is the same as for IU/L (International System). For example, 15.6 mIU/mL equals 15.6 IU/L.

Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted with Calibrator A and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the SeaLite Sciences, Inc. AquaLite® LH immunoassay, structured as requested:

Acceptance Criteria and Device Performance (AquaLite® LH)

Note: This document does not explicitly state pre-defined "acceptance criteria" but rather reports the performance characteristics observed during testing. The reported performance is the criteria met for demonstrating safety and effectiveness compared to other commercially available assays for LH.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• Sensitivity: 20 replicates of the zero-level calibrator.
• Specificity (Cross-reactivity): Aliquots of WHO/NIBSC preparations (specific quantities not detailed beyond "diluted to the following levels").
• Intra-assay precision: N = 20 per solution (three different concentrations).
• Inter-assay precision: N = 20 (10 assays, duplicate measurements per assay) per solution (three different concentrations).
• Method Comparison: N = 62 patient samples.
• Linearity and Nonparallelism: Three human serum samples (SLS#4, SLS#18, SLS#26) subjected to serial dilutions.
• Spike and Recovery: Eight normal male human serum samples.
• Recovery in Serum and Plasma: Blood samples from 2 normal subjects, processed into various types of serum and plasma.
• Effect of Common Interferents: Pooled normal male human serum.

Data Provenance:

• Country of Origin: Not explicitly stated for all samples. However, human sialoglycoprotein hormones for specificity were supplied by the World Health Organization's National Institute for Biological Standards and Control (London, England).
• Retrospective or Prospective: Unclear for patient samples. The study involved controlled laboratory experiments using commercial controls, patient samples, and spiked samples.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not applicable. The ground truth for this in vitro diagnostic (IVD) device is typically established by:
  • Calibrators: Precisely defined concentrations of the analyte.
  • Reference Methods: Established methods (e.g., the "commercially available kit" for method comparison) that are accepted as accurate.
  • Known Spiked Concentrations: Artificially created samples with a defined amount of analyte.
• Qualifications of Experts: Not applicable in the context of establishing ground truth for an IVD test.

4. Adjudication Method (Test Set)

• Not applicable for an in vitro diagnostic (IVD) device where ground truth is based on quantitative measurements against known standards or established reference methods, not expert interpretation of images or clinical data requiring adjudication.

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

• Not done. This is an in vitro diagnostic (IVD) device for quantitative measurement of an analyte. MRMC studies are typically for imaging devices or devices requiring human interpretation.

6. Standalone Performance (Algorithm Only)

• Yes, implied. The entire study describes the performance of the AquaLite® LH assay itself, which is a standalone in vitro test kit. There is no human-in-the-loop performance component beyond operating the luminometer and interpreting the calibration curve.

7. Type of Ground Truth Used

• Reference/Assigned Values:
  • Calibrators: For sensitivity, intra-assay, and inter-assay precision.
  • World Health Organization's National Institute for Biological Standards and Control (WHO/NIBSC) preparations: For specificity/cross-reactivity.
  • Commercial Reference Kit: For method comparison (the "commercially available kit").
  • Known Spiked Concentrations: For linearity and spike & recovery.
  • Expected values based on dilution: For linearity.

8. Sample Size for the Training Set

• The document describes performance studies for a finished in vitro diagnostic kit. It does not mention a "training set" in the typical machine learning sense. The device is a chemical immunoassay, not an AI/ML algorithm that requires training on a dataset in that manner. Any "training" would refer to the internal development and optimization of the assay by SeaLite Sciences, Inc., the details of which are not provided here.

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

• Not applicable. As stated above, this is not an AI/ML device with a "training set" in the conventional sense. The development of the assay would have involved various optimization steps using known concentrations of LH and other related substances, but these would fall under assay development rather than "training set ground truth establishment."

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