(348 days)
ADVIA Centaur® Testosterone II (TSTII)
The ADVIA Centaur Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.
Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
ADVIA Centaur® Testosterone II (TSTII) Master Curve Material
The ADVIA Centaur Testosterone II (TSTI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Testosterone II (TSTII) assay.
ADVIA Centaur® SHBG
The ADVIA Centaur SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.
The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
ADVIA Centaur® SHBG Calibrator
For in vitro diagnostic use in calibrating the ADVIA Centaur SHBG assay on the ADVIA Centaur systems.
ADVIA Centaur® SHBG Master Curve Material
The ADVIA Centaur SHBG Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur SHBG assay.
The submission describes several components:
ADVIA Centaur TSTII Assay Components: Includes ADVIA Centaur TSTII Primary Reagent ReadyPack (Lite Reagent and Solid Phase Reagent), ADVIA Centaur TSTII Ancillary Reagent ReadyPack (Releasing Agent), and ADVIA Centaur TSTII Calibrator (Low and High Calibrators). The ingredients are listed in Table 6.
ADVIA Centaur TSTII Master Curve Material: Includes ADVIA Centaur TSTII MCM1 and MCM2-7. The ingredients are listed in Table 6.
ADVIA Centaur SHBG Assay Components: Includes ADVIA Centaur SHBG Primary Reagent ReadyPack (Lite Reagent and Solid Phase Reagent), and ADVIA Centaur SHBG Ancillary Well Reagent. The ingredients are listed in Table 7.
ADVIA Centaur SHBG Calibrator: Includes ADVIA Centaur SHBG Low and High Calibrators. The ingredients are listed in Table 7.
ADVIA Centaur SHBG Master Curve Material: Includes ADVIA Centaur SHBG MCM1-5. The ingredients are listed in Table 8.
The ADVIA Centaur TSTII assay uses a chemiluminescence competitive immunoassay methodology. The ADVIA Centaur SHBG assay uses a chemiluminescence sandwich immunoassay methodology. Both assays are intended for use on the ADVIA Centaur XP system.
The provided document describes the acceptance criteria and study results for the ADVIA Centaur Testosterone II (TSTII) assay and the ADVIA Centaur SHBG assay.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since the document does not explicitly present a table of predetermined acceptance criteria with a pass/fail column, I will infer the acceptance criteria from the context provided (e.g., studies performed and expected deviations/recoveries). The "Reported Device Performance" column will contain the results from the studies presented.
ADVIA Centaur Testosterone II (TSTII) Assay:
| Performance Characteristic | Inferred Acceptance Criteria (Based on typical IVD expectations and study narrative) | Reported Device Performance |
|---|---|---|
| Precision | CVs generally 0.95) and minimal bias compared to reference method/predicate | CDC HoSt Testosterone ID-LC-MS/MS: ADVIA Centaur TSTII = 0.97(ID-LC-MS/MS) + 1.94 ng/dL (r = 0.98) |
| Dimension Vista TST (Adult & Pediatric): ADVIA Centaur TSTII = 1.01(Dimension Vista TST) + 0.99 ng/dL (r = 0.99) | ||
| Dimension Vista TST (Pediatric): ADVIA Centaur TSTII = 1.04(Dimension Vista TST) + 0.22 ng/dL (r = 0.99) | ||
| Matrix Comparison | No significant difference or acceptable correlation between tube types | Slope: 0.94-0.98, Intercept: -1.61 to 4.50 ng/dL, r: 0.991-0.996 (No significant difference observed) |
| Detection Limits (LoQ) | LoQ should be clinically relevant and achievable | LoQ: 7.00 ng/dL |
| Interference | Acceptable interference percentages for common interferents | Hemoglobin (-0.4 to 5.8%), Triglycerides (-8.5 to 1.2%), Conjugated Bilirubin (-4.1 to 4.2%), Unconjugated Bilirubin (3.2 to 9.6%), Cholesterol (-9.4 to 6.4%), Rheumatoid Factor (0.7 to 4.6%). |
| Biotin: 10% interference at 30 ng/mL. | ||
| Conjugated Bilirubin: >15 mg/dL causes erroneous results (~-14.4% change at 20 mg/dL). | ||
| Unconjugated Bilirubin: >20 mg/dL causes erroneous results (~20.1% change at 30 mg/dL). | ||
| Heterophile Interference | Mean recovery close to 100% (e.g., 90-110%) | Mean recovery for ~30 ng/dL: 98.69% |
| Mean recovery for ~300 ng/dL: 94.55% | ||
| Cross-Reactivity | Specificity for testosterone with minimal cross-reactivity from other steroids | Varied, with some substances showing higher cross-reactivity (e.g., 11β-Hydroxytestosterone, Ethisterone, Testosterone propionate). Specific percentages are provided in the table. |
ADVIA Centaur SHBG Assay:
| Performance Characteristic | Inferred Acceptance Criteria (Based on typical IVD expectations and study narrative) | Reported Device Performance |
|---|---|---|
| Precision | CVs generally 0.95) and minimal bias compared to predicate | ADVIA Centaur SHBG = 0.99(Elecsys) - 0.11 nmol/L (r = 0.99) |
| Detection Limits (LoQ) | LoQ should be clinically relevant and achievable | LoQ: 1.8 nmol/L |
2. Sample sizes used for the test set and the data provenance:
- ADVIA Centaur Testosterone II (TSTII) Assay:
- Precision: 5 serum patient pools, 3 control levels, 1 female patient serum specimen. Assayed twice a day in replicates of 2 for 20 days (n = 80 replicates per sample).
- Linearity: 11 serially diluted samples. Each sample tested in duplicate.
- Dilution Recovery: 5 serum samples.
- Method Comparison:
- Against CDC HoSt Testosterone ID-LC-MS/MS: 128 serum samples.
- Against Dimension Vista Total Testosterone: 117 serum samples (adults) and 61 samples (pediatrics). The pediatric samples consisted of 27 females (age 7-18) and 34 males (age 9-18).
- Matrix Comparison: Minimum of 50 matched specimens for each tube type (serum red top, serum separator tube, plasma separator tube, dipotassium EDTA, lithium heparin, and sodium heparin).
- Reference Intervals:
- Adults: 119-167 samples per group (Males Age
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.