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The IMMULITE® HCG Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE HCG assay on the IMMULITE 2000 systems.
The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems.
The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Pyrilinks-D assay on the IMMULITE 2000 systems.
The IMMULITE® Homocysteine Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Homocysteine assay on the IMMULITE 2000 systems.
The IMMULITE® Growth Hormone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Growth Hormone assay on the IMMULITE 2000 systems.
IMMULITE® 2000 HCG Calibration Verification Material: The Calibration Verification Material (CVM) contains One set of four vials each 3mL. CVM1 contains HCG-free human serum with preservatives. CVM2. CVM3 and CVM4 contain HCG added to HCG-free human serum respectively, with preservatives.
IMMULITE® 2000 Insulin Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVMI contains an equine serum matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of insulin in an equine serum matrix with preservatives.
IMMULITE® 2000 Pyrilinks-D Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM1 contains a phosphoric acid and sodium chloride matrix. CVM2, CVM3 and CVM4 contain various levels of H-Deoxypyridinoline in a phosphoric acid and sodium chloride matrix.
IMMULITE® 2000 Homocysteine Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2mL each. CVM 1 contains a bovine protein/buffer matrix with preservatives. CVM2, CVM3 and CVM4, contain various levels of s-adenosyl-L-homocysteine in a bovine protein/buffer matrix with preservatives.
IMMULITE® 2000 Growth Hormone Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM 1 contains an equine serum matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of human growth hormone in equine serum matrix with preservatives.
The provided text describes the acceptance criteria and performance data for several Calibration Verification Materials (CVMs) for the IMMULITE 2000 system, specifically for HCG, Insulin, Pyrilinks-D, Homocysteine, and Growth Hormone assays. The information is presented in sections relating to each CVM. I will extract the requested information for each CVM separately.
IMMULITE® 2000 HCG Calibration Verification Material
1. A table of acceptance criteria and the reported device performance:
| CVM Level | Assigned Dose (mIU/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (mIU/mL) | Reported Performance (Guideline Range based on Target Mean & ±2SD) (mIU/mL) |
|---|---|---|---|---|
| LCGCVM1 | 0.00 | N/A | <0.40 | ≤0.40 |
| LCGCVM2 | 9.35 | ±12% | 8.23 - 10.47 | 4.59 - 6.21 (Note: Target Mean for CVM2 is 5.4, not 9.35 as in accepted criteria table) |
| LCGCVM3 | 654 | ±8% | 601.68 - 706.32 | 588 - 734 (Note: Target Mean for CVM3 is 661, not 654) |
| LCGCVM4 | 5327 | ±23% | 4101.79 - 6552.21 | 3823 - 6107 (Note: Target Mean for CVM4 is 4965, not 5327) |
| Assay Range | 1 - 5000 mIU/mL | 1 - 5000 mIU/mL |
Review Limits (Part 2 criteria for all levels): Controls are within 2SD of the control target value when generated from the stability calibrator curve.
The reported performance (Guideline ±2SD Range) in section 7.4 ("Expected Values/Reference Range") is related to the "Target Mean" which differs from the "Assigned Dose" in the acceptance criteria table (Table 3), specifically for CVM levels 2, 3, and 4. This suggests a potential discrepancy between the defined acceptance criteria values and the target values used to generate the performance data.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of device performance directly against acceptance criteria. However, for "Value Assignment" and "Expected Values/Reference Range":
- Six levels of commercially available controls and 30 pregnancy samples were used to validate calibrator/CVM value assignments.
- Each CVM level was tested for a total of 15 replicates (5 runs and 3 replicates per run) for establishing expected values/reference range.
- Data provenance: Not specified (e.g., country of origin). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for the CVMs is based on assigned reference calibrators traceable to WHO 3rd IS (75/537) and internal manufacturing/measurement procedures.
4. Adjudication method for the test set:
- Not applicable. The stability acceptance criteria include a two-part review process:
- Part 1: Dose value within a specified percentage difference of the assigned dose.
- Part 2 (if Part 1 fails): Dose value of controls must be within 2SD of the control target value when generated from the stability calibrator curve.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a non-clinical performance study for in vitro diagnostic calibration verification materials, not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a stability and value assignment study for chemical calibrators.
7. The type of ground truth used:
- Traceability: The IMMULITE HCG CVMs are traceable to WHO 3rd IS (75/537).
- Value Assignment: CVMs are value assigned using assigned reference calibrators prepared using HCG antigen spiked in a human serum matrix with preservatives, traceable to WHO 3rd IS (75/537).
8. The sample size for the training set:
- Not applicable. This is not a machine learning model, so there isn't a "training set" in that sense. However, for developing the values, 15 replicates across 5 systems and 3 different reagent kit lots were used to generate CVM values, and 6 levels of commercially available controls and 30 pregnancy samples were used to validate value assignments.
9. How the ground truth for the training set was established:
- Not applicable. The "ground truth" (assigned values) is established through traceability to international standards (WHO 3rd IS (75/537)) and internal gravimetric preparation and measurement procedures.
IMMULITE® 2000 Insulin Calibration Verification Material
1. A table of acceptance criteria and the reported device performance:
| CVM Level | Assigned Dose (µIU/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (µIU/mL) | Reported Performance (Guideline Range based on Target Mean & ±2SD) (µIU/mL) |
|---|---|---|---|---|
| LINCVM1 | 0.00 | N/A | <2.00 | ≤2.00 |
| LINCVM2 | 7.00 | ±12% | 6.16 - 7.84 | 5.95 - 8.05 |
| LINCVM3 | 26.1 | ±10% | 23.49 - 28.71 | 23.5 - 28.7 |
| LINCVM4 | 418 | ±13% | 363.66 - 472.34 | Not directly reported (Target Mean 418, but a diluted sample 314* is reported) |
| CVM4* | 314 | N/A (Diluted) | N/A | 273 - 355 (for diluted CVM4) |
| Assay Range | 0.2 - 300 µIU/mL | 0.2 - 300 µIU/mL |
Review Limits (Part 2 criteria for all levels): Controls are within 2SD of the control target value when generated from the stability calibrator curve.
The reported performance for CVM4 in the "Expected Values/Reference Range" section is for a diluted sample (75% CVM4 + 25% CVM1), not the raw "Assigned Dose" of 418 µIU/mL. This note indicates that CVM4 requires dilution for testing.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of device performance directly against acceptance criteria. However, for "Value Assignment" and "Expected Values/Reference Range":
- Two levels of commercially available controls and 30 patient samples (20 normal, 10 spiked) were used to validate calibrator/CVM value assignments.
- Each CVM level was tested for a total of 26 replicates (9 runs and 2 or 3 replicates per run) for establishing expected values/reference range.
- Data provenance: Not specified (e.g., country of origin). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the CVMs is based on assigned reference calibrators traceable to WHO NIBSC 1st IRP (66/304) and internal manufacturing/measurement procedures.
4. Adjudication method for the test set:
- Not applicable. The stability acceptance criteria include a two-part review process:
- Part 1: Dose value within a specified percentage difference of the assigned dose.
- Part 2 (if Part 1 fails): Dose value of controls must be within 2SD of the control target value when generated from the stability calibrator curve.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a non-clinical performance study for in vitro diagnostic calibration verification materials, not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a stability and value assignment study for chemical calibrators.
7. The type of ground truth used:
- Traceability: The IMMULITE Insulin CVMs are traceable to WHO NIBSC 1st IRP (66/304).
- Value Assignment: CVMs are value assigned using assigned reference calibrators prepared using recombinant human Insulin antigen spiked into horse Serum with preservatives.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model. For developing the values, 26 replicates across 7 systems and 5 different reagent kit lots were used to generate CVM values, and 2 levels of commercially available controls and 30 patient samples were used to validate value assignments.
9. How the ground truth for the training set was established:
- Not applicable. The "ground truth" (assigned values) is established through traceability to international standards (WHO NIBSC 1st IRP (66/304)) and internal gravimetric preparation and measurement procedures.
IMMULITE® 2000 Pyrilinks-D Calibration Verification Material
1. A table of acceptance criteria and the reported device performance:
| CVM Level | Assigned Dose (nmol/L) | Guideline Criteria % difference to assigned dose | Acceptable dose range (nmol/L) | Reported Performance (Guideline Range based on Target Mean & ±2SD) (nmol/L) |
|---|---|---|---|---|
| LPDCVM1 | 0.00 | N/A | <7.00 | ≤7.00 |
| LPDCVM2 | 18.30 | ±10% | 16.47 - 20.13 | 16.3 - 22.8 (Note: Target Mean for CVM2 is 16.3, not 18.30) |
| LPDCVM3 | 49.00 | ±10% | 44.10 - 53.90 | 49.2 - 60.0 (Note: Target Mean for CVM3 is 49.2, not 49.00) |
| LPDCVM4 | 302.00 | ±10% | 271.80 - 332.20 | 301 - 331 (Note: Target Mean for CVM4 is 301, not 302.00) |
| Assay Range | 7 - 300 nmol/L | 7 - 300 nmol/L |
Review Limits (Part 2 criteria for all levels): Controls are within 2SD of the control target value when generated from the stability calibrator curve.
The reported performance (Guideline ±2SD Range) in section 7.4 ("Expected Values/Reference Range") shows slightly different "Target Mean" values compared to the "Assigned Dose" in the acceptance criteria table (Table 3) for CVM levels 2, 3, and 4.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of device performance directly against acceptance criteria. However, for "Value Assignment" and "Expected Values/Reference Range":
- Two levels of commercially available controls and 30 patient female urine samples were used to validate calibrator/CVM value assignments.
- Each CVM level was tested for a total of 15 replicates (5 runs and 3 replicates per run) for establishing expected values/reference range.
- Data provenance: Not specified (e.g., country of origin). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the CVMs is based on internal gravimetrically prepared material and manufacturing/measurement procedures.
4. Adjudication method for the test set:
- Not applicable. The stability acceptance criteria include a two-part review process:
- Part 1: Dose value within a specified percentage difference of the assigned dose.
- Part 2 (if Part 1 fails): Dose value of controls must be within 2SD of the control target value when generated from the stability calibrator curve.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a non-clinical performance study for in vitro diagnostic calibration verification materials, not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a stability and value assignment study for chemical calibrators.
7. The type of ground truth used:
- Traceability: The IMMULITE Pyrilinks-D CVMs are traceable to internal material which has been gravimetrically prepared.
- Value Assignment: CVMs are value assigned using assigned reference calibrators prepared using Hydrolysed Deoxypyridiniline antigen spiked in a phosphoric acid and sodium chloride matrix in deionised water.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model. For developing the values, 15 replicates across 4 systems and 3 different reagent kit lots were used to generate CVM values, and 2 levels of commercially available controls and 30 patient female urine samples were used to validate value assignments.
9. How the ground truth for the training set was established:
- Not applicable. The "ground truth" (assigned values) is established through traceability to internal gravimetrically prepared material and internal manufacturing/measurement procedures.
IMMULITE® 2000 Homocysteine Calibration Verification Material
1. A table of acceptance criteria and the reported device performance:
| CVM Level | Assigned Dose (µmol/L) | Guideline Criteria % difference to assigned dose | Acceptable dose range (µmol/L) | Reported Performance (Guideline Range based on Target Mean & ±2SD) (µmol/L) |
|---|---|---|---|---|
| LHOCVM1 | 0.00 | N/A | <2.0 | ≤2.0 |
| LHOCVM2 | 4.12 | ±15% | 3.50 - 4.74 | 3.25 - 4.97 (Note: Target Mean for CVM2 is 4.11, not 4.12) |
| LHOCVM3 | 17.60 | ±10% | 15.84 - 19.36 | 15.8 - 19.3 (Note: Target Mean for CVM3 is 17.5, not 17.60) |
| LHOCVM4 | 71.50 | ±10% | 64.35 - 78.65 | Not directly reported (Target Mean 73.0, but a diluted sample 51.1* is reported) |
| CVM4* | 51.1 | N/A (Diluted) | N/A | 46.0 - 56.2 (for diluted CVM4) |
| Assay Range | 2 - 50 µmol/L | 2 - 50 µmol/L |
Review Limits (Part 2 criteria for all levels): Controls are within 2SD of the control target value when generated from the stability calibrator curve.
The reported performance for CVM4 in the "Expected Values/Reference Range" section is for a diluted sample (70% CVM4 + 30% CVM1), not the raw "Assigned Dose" of 71.50 µmol/L. This note indicates that CVM4 requires dilution for testing.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of device performance directly against acceptance criteria. However, for "Value Assignment" and "Expected Values/Reference Range":
- Two levels of commercially available controls and 40 samples (30 spiked, 5 normal, 5 patient) were used to validate calibrator/CVM value assignments.
- Each CVM level was tested for a total of 27 replicates (9 runs and 3 replicates per run) for establishing expected values/reference range.
- Data provenance: Not specified (e.g., country of origin). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the CVMs is based on internal gravimetrically prepared material and manufacturing/measurement procedures.
4. Adjudication method for the test set:
- Not applicable. The stability acceptance criteria include a two-part review process:
- Part 1: Dose value within a specified percentage difference of the assigned dose.
- Part 2 (if Part 1 fails): Dose value of controls must be within 2SD of the control target value when generated from the stability calibrator curve.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a non-clinical performance study for in vitro diagnostic calibration verification materials, not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a stability and value assignment study for chemical calibrators.
7. The type of ground truth used:
- Traceability: The IMMULITE Homocysteine CVMs are traceable to internal material which has been gravimetrically prepared.
- Value Assignment: CVMs are value assigned using assigned reference calibrators prepared using s-adenosyl-L-homocysteine spiked into a Bovine protein/buffer matrix, traceable to internal gravimetrically prepared material.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model. For developing the values, 27 replicates across 7 systems and 3 different reagent kit lots were used to generate CVM values, and 2 levels of commercially available controls and 40 samples were used to validate value assignments.
9. How the ground truth for the training set was established:
- Not applicable. The "ground truth" (assigned values) is established through traceability to internal gravimetrically prepared material and internal manufacturing/measurement procedures.
IMMULITE® 2000 Growth Hormone Calibration Verification Material
1. A table of acceptance criteria and the reported device performance:
| CVM Level | Assigned Dose (ng/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (ng/mL) | Reported Performance (Guideline Range based on Target Mean & ±2SD) (ng/mL) |
|---|---|---|---|---|
| LGRHCVMI | 0.00 | N/A | <0.01 | ≤0.01 |
| LGRHCVM2 | 0.61 | ±12% | 0.54 - 0.68 | 0.457 - 0.593 (Note: Target Mean for CVM2 is 0.525, not 0.61) |
| LGRHCVM3 | 9.6 | ±10% | 8.64 - 10.56 | 7.38 - 9.02 (Note: Target Mean for CVM3 is 8.20, not 9.6) |
| LGRHCVM4 | 40 | ±12% | 35.20 - 44.80 | 33.4 - 43.4 (Note: Target Mean for CVM4 is 38.4, not 40) |
| Assay Range | 0.05 - 40 ng/mL | 0.05 - 40 ng/mL |
Review Limits (Part 2 criteria for all levels): Controls are within 2SD of the control target value when generated from the stability calibrator curve.
The reported performance (Guideline ±2SD Range) in section 7.4 ("Expected Values/Reference Range") shows slightly different "Target Mean" values compared to the "Assigned Dose" in the acceptance criteria table (Table 3) for CVM levels 2, 3, and 4.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of device performance directly against acceptance criteria. However, for "Value Assignment" and "Expected Values/Reference Range":
- Six levels of commercially available controls and 30 patient samples (10 normal, 20 spiked) were used to validate calibrator/CVM value assignments.
- Each CVM level was tested for a total of 27 replicates (9 runs and 3 replicates per run) for establishing expected values/reference range.
- Data provenance: Not specified (e.g., country of origin). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the CVMs is based on assigned reference calibrators traceable to WHO 2nd IS (98/574) and internal manufacturing/measurement procedures.
4. Adjudication method for the test set:
- Not applicable. The stability acceptance criteria include a two-part review process:
- Part 1: Dose value within a specified percentage difference of the assigned dose.
- Part 2 (if Part 1 fails): Dose value of controls must be within 2SD of the control target value when generated from the stability calibrator curve.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a non-clinical performance study for in vitro diagnostic calibration verification materials, not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a stability and value assignment study for chemical calibrators.
7. The type of ground truth used:
- Traceability: The IMMULITE Growth Hormone CVMs are traceable to WHO 2nd IS (98/574).
- Value Assignment: CVMs are value assigned using assigned reference calibrators prepared with human Growth Hormone spiked in an equine serum matrix with preservatives.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model. For developing the values, 27 replicates across 7 systems and 4 different reagent kit lots were used to generate CVM values, and 6 levels of commercially available controls and 30 patient samples were used to validate value assignments.
9. How the ground truth for the training set was established:
- Not applicable. The "ground truth" (assigned values) is established through traceability to international standards (WHO 2nd IS (98/574)) and internal manufacturing/measurement procedures.
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