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FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

The FastPack® IP Sex Hormone Binding Globulin Immunoassay employs a sandwich immunoassay principle. Endogenous SHBG in a patient sample, calibrator, or control is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-SHBG antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-SHBG antibody linked to biotin will bind to streptavidin coated paramagnetic particles (PMP). After incubation, washing steps (using a Tris buffer containing detergents) occur to separate bound from unbound anti-SHBG monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of SHBG in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

Here's an analysis of the provided text regarding the FastPack® IP Sex Hormone Binding Globulin Immunoassay's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a separate section. However, based on the comparative effectiveness study against a predicate device and the presented performance data, we can infer some implied acceptance ranges or targets for the new device.

• Within-Run: 2.74% - 6.95%
• Between-Run: 0.00% - 7.79%
• Between-Day: 0.00% - 4.96%
• Total: 3.21% - 7.06%

Reagent lot 2, analyzer 2, calibrator lot 2:

• Within-Run: 4.16% - 7.74%
• Between-Run: 0.00% - 6.56%
• Between-Day: 1.25% - 7.44%
• Total: 5.04% - 11.53%

Reagent lot 3, analyzer 3, calibrator lot 3:

• Within-Run: 3.4% - 9.60%
• Between-Run: 0.0% - 7.21%
• Between-Day: 0.0% - 6.05%
• Total: 4.0% - 12.05% |
  | Linearity | Assay linear within a specified range (Predicate: 0.33 - 200 nmol/L) | Linear from LOQ (0.80 nmol/L) to 174 nmol/L |
  | Interfering Substances | No interference at specified levels (similar to predicate) | No interference with listed compounds (e.g., conjugated bilirubin 40 mg/dL, hemoglobin 1.0 g/dL, lipid 1000 mg/dL, d-Biotin 0.2 mg/dL) and cross-reactants (e.g., Transferrin 0.5 g/dL, Testosterone 2.5 mg/dL, etc.) at specified concentrations. Rheumatoid factor up to 1000 IU/mL and human anti-mouse IgG up to 4 µg/mL also showed no cross-reactivity. Six known heterophile samples did not generate detectable interference. |
  | Method Comparison | Strong correlation to predicate (Predicate R2 = 0.94) | R = 0.985, Slope (95% CI): 0.993 (0.967-1.019), y-intercept (95% CI): -0.614 (-2.21 to 0.982), R2 = 0.971 |
  | Sample Type Equivalence| Equivalence between serum and plasma | Strong correlation between serum and lithium-heparin plasma via Passing-Bablok regression: Slope (95% CI): 0.960 (0.920-1.00), y-intercept (95% CI): 1.859 (-0.89 to 4.61), R = 0.990, R2 = 0.979. Absolute bias 1.117 nmol/L, % Bias 1.928%. |
  | LOB | Not explicitly stated for acceptance, but a calculated value | 0.08 nmol/L SHBG |
  | LOD | Not explicitly stated for acceptance, but a calculated value | 0.20 nmol/L SHBG |
  | LOQ | Lowest sample with

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