Search Results

The Atellica® CH Phencyclidine (Pcp) assay is for in the qualitative or semiguantitative analyses of phencyclidine in human urine using the Atellica® CI Analyzer, using a cutoff of 25 ng/mL. The Pop assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography-mass spectrometry (GCMS) is the preferred confirmatory method. The semiquantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS) or liquid chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Atellica® CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum and plasma (lithium heparin) using the Atellica® CI Analyzer. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The Atellica CH Pcp assay is a homogenous enzyme immunoassay based on competition between drug in the specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm. Endogenous G6PDH does not interfere because the coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

The Atellica CH Vanc assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 and 694 nm.

This document describes the analytical performance of two in vitro diagnostic (IVD) assays, the Atellica® CH Phencyclidine (Pcp) assay and the Atellica® CH Vancomycin (Vanc) assay, and does not contain information related to AI/ML clinical studies or multi-reader multi-case (MRMC) comparative effectiveness studies. Therefore, it is not possible to address acceptance criteria and study designs typically found in AI/ML performance evaluations (e.g., sample size for training/test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.).

However, I can extract and present the analytical performance criteria and reported device performance based on the provided text, which are relevant for IVD devices.

Analytical Acceptance Criteria and Reported Device Performance

Atellica® CH Phencyclidine (Pcp) Assay

This assay is for qualitative or semi-quantitative analysis of phencyclidine in human urine. The primary "acceptance" is demonstrated through agreement with a confirmatory method (GC/MS) and robust precision and recovery.

Table 1: Atellica® CH Phencyclidine (Pcp) Assay - Analytical Performance

• Overall POS agreement: 95% (19 true positives + 81 high positives / 108 total positives by Atellica CH)
• Overall NEG agreement: 94% (42 low negatives + 7 negatives / 54 total negatives by Atellica CH)
  Discordant Results (Atellica CI Pcp vs GC/MS cut-off 25 ng/mL):
• Atellica POS, GC/MS NEG: Samples 47 (27 ng/mL vs 18.0 ng/mL), 51 (30 ng/mL vs 24.2 ng/mL), 52 (26 ng/mL vs 24.8 ng/mL) - 3 false positives relative to GC/MS cut-off
• Atellica NEG, GC/MS POS: Samples 53 (21 ng/mL vs 25.8 ng/mL), 54 (20 ng/mL vs 26.7 ng/mL), 56 (22 ng/mL vs 27.6 ng/mL), 57 (24 ng/mL vs 27.8 ng/mL), 58 (24 ng/mL vs 28.5 ng/mL) - 5 false negatives relative to GC/MS cut-off |
  | Precision (Repeatability) | Overall Low CV% (e.g., 2.2% at 18.75 ng/mL, 2.4% at 25 ng/mL, 2.8% at 31.25 ng/mL)
• 0 ng/mL: SD 0.1, N/A CV
• 6.25 ng/mL: SD 0.4, 6.7% CV
• 12.5 ng/mL: SD 0.4, 3.3% CV
• 18.75 ng/mL: SD 0.4, 2.2% CV
• 25 ng/mL (Cutoff): SD 0.6, 2.4% CV
• 31.25 ng/mL: SD 0.9, 2.8% CV
• 37.5 ng/mL: SD 0.9, 2.3% CV
• 43.75 ng/mL: SD 1.1, 2.6% CV
• 50 ng/mL: SD 1.7, 3.3% CV |
  | Precision (Within-Lab) | Overall Low CV% (e.g., 4.4% at 18.75 ng/mL and 25 ng/mL, 5.3% at 31.25 ng/mL)
• 0 ng/mL: SD 0.20, N/A CV
• 6.25 ng/mL: SD 0.6, 10.0% CV
• 12.5 ng/mL: SD 0.6, 5.0% CV
• 18.75 ng/mL: SD 0.8, 4.4% CV
• 25 ng/mL (Cutoff): SD 1.1, 4.4% CV
• 31.25 ng/mL: SD 1.7, 5.3% CV
• 37.5 ng/mL: SD 2.3, 5.9% CV
• 43.75 ng/mL: SD 2.5, 5.8% CV
• 50 ng/mL: SD 3.7, 7.1% CV |
  | Reproducibility (Total) | Overall Low CV% (e.g., 6.1% for Urine QC 1, 5.8% for Urine QC 2, 6.5% for Urine QC 3)
• Urine QC 1 (18 ng/mL): SD 1.1, 6.1% CV
• Urine QC 2 (24 ng/mL): SD 1.4, 5.8% CV
• Urine QC 3 (34 ng/mL): SD 2.2, 6.5% CV |
  | Recovery | Mean Recovery ranging from 90% to 107% across various concentrations.
• 0 ng/mL: 0 ng/mL (N/A %)
• 4 ng/mL: 4 ng/mL (101 %)
• 5 ng/mL: 5 ng/mL (100 %)
• 10 ng/mL: 9 ng/mL (90 %)
• 15 ng/mL: 15 ng/mL (100 %)
• 20 ng/mL: 19 ng/mL (95 %)
• 25 ng/mL: 24 ng/mL (96 %)
• 30 ng/mL: 30 ng/mL (100 %)
• 40 ng/mL: 43 ng/mL (107 %)
• 60 ng/mL: 64 ng/mL (107 %)
• 80 ng/mL: 82 ng/mL (103 %) |
  | Endogenous Substances Interference | No false response relative to the 25 ng/mL cutoff for tested substances (Acetone, Ascorbic Acid, Conjugated bilirubin, Creatinine, Ethanol, Gamma Globulin, Galactose, Glucose, Hemoglobin, Human Serum Albumin, Oxalic Acid, Riboflavin, Sodium Azide, Sodium Chloride, Sodium Fluoride, Urea) at specified concentrations when spiked into control pools (19 ng/mL and 31 ng/mL). |
  | Specificity (Structurally Unrelated Compounds) | No false response relative to the 25 ng/mL cutoff for listed structurally unrelated compounds (e.g., Acetaminophen, Amitriptyline, Caffeine, Ibuprofen, etc.) at specified concentrations when spiked into control pools (19 ng/mL and 31 ng/mL). |
  | Specificity (Structurally Related Compounds - Cross-Reactivity) | Values range from 0.0% to 184.4% for structurally related compounds, indicating varying levels of cross-reactivity. Notably, 1-(1-Phenylcyclohexyl)pyrrolidine (PCPy) showed 154.4% and trans-4-phenyl-4-Piperidinocyclohexanol showed 184.4% cross-reactivity. This typically means these compounds may cause a positive result even if PCP itself is not present, emphasizing the need for confirmatory testing. |
  | Specific Gravity and pH Interference | No interference observed for negative urine pools with specific gravity 1.000–1.030 and pH 3–10, when tested at ±25% of the cutoff concentration. |
  | Standardization Traceability | Traceable to Emit Calibrators/Controls, which are referenced to gravimetrically prepared standards qualified by GC/MS from an independent laboratory (within ±10% of nominal). |

Atellica® CH Vancomycin (Vanc) Assay

This assay is for quantitative measurement of vancomycin in human serum and plasma.

Table 2: Atellica® CH Vancomycin (Vanc) Assay - Analytical Performance

• Serum QC 1 (6.1 µg/mL): SD 0.14, 2.3% CV
• Serum 1 (13.4 µg/mL): SD 0.13, 1.0% CV
• Serum QC 2 (19.5 µg/mL): SD 0.15, 0.8% CV
• Serum QC 3 (32.6 µg/mL): SD 0.34, 1.0% CV
• Serum 2 (46.1 µg/mL): SD 0.54, 1.2% CV |
  | Precision (Within-Laboratory) | Overall Low CV% (e.g., 1.5% - 2.8%).
• Serum QC 1 (6.1 µg/mL): SD 0.17, 2.8% CV
• Serum 1 (13.4 µg/mL): SD 0.20, 1.5% CV
• Serum QC 2 (19.5 µg/mL): SD 0.33, 1.7% CV
• Serum QC 3 (32.6 µg/mL): SD 0.61, 1.9% CV
• Serum 2 (46.1 µg/mL): SD 0.89, 1.9% CV |
  | Reproducibility (Total) | Overall Low CV% (e.g., 1.8% - 4.0%).
• Serum QC 1 (6.0 µg/mL): SD 0.24, 4.0% CV
• Serum 1 (13.4 µg/mL): SD 0.27, 2.0% CV
• Serum QC 2 (19.7 µg/mL): SD 0.38, 1.9% CV
• Serum QC 3 (32.9 µg/mL): SD 0.62, 1.9% CV
• Serum 2 (45.9 µg/mL): SD 0.81, 1.8% CV |
  | Assay Comparison (Correlation vs. Predicate) | Correlation coefficient ≥ 0.980 and slope 1.00 ± 0.10.
• Regression Equation: y = 0.97x + 0.3 µg/mL (y = 0.97x + 0.2 µmol/L)
• Correlation coefficient (r): 0.999 (for 107 serum samples in range 4.1–45.9 µg/mL). Meets criteria. |
  | Specimen Equivalency (Serum vs. Plasma (Lithium Heparin)) | Demonstrated equivalency between plasma and serum.
• Regression Equation: y = 1.00x - 0.1 µg/mL (y = 1.00x - 0.7 µmol/L)
• Correlation coefficient (r): 0.996 (for 50 samples in range 4.5–43.9 µg/mL). |
  | Interferences (Hemolysis, Icterus, Lipemia - HIL) | ≤ 10% bias.
• Hemoglobin (1000 mg/dL): 2% and 6% bias at two analyte levels.
• Bilirubin, conjugated (30 mg/dL): 0% and 1% bias.
• Bilirubin, unconjugated (30 mg/dL): -2% and -1% bias.
• Lipemia (Intralipid® 2000 mg/dL): 8% and 6% bias.
• Lipemia (from trig fraction 2000 mg/dL): 6% and 8% bias. *All results meet the

Ask a specific question about this device