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The Dimension® EXL™ LOCI® BRAHMS Procalcitonin (PCT) assay is an in vitro diagnostic test for the quantitative measurement of procalcitonin in human serum and plasma (lithium heparin, K2EDTA, and K3EDTA) using the Dimension® EXL™ integrated chemistry system with LOCI® Module.

The Dimension EXL LOCI® BRAHMS PCT assay is intended for use in conjunction with other laboratory findings and clinical assessments, as an aid in:

· The risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.

• Assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission using percentage change in PCT levels over time.

· Decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) - defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) - in an inpatient setting or an emergency department.

· Decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Device Description

The Dimension EXL LOCI BRAHMS PCT assay is a homogeneous sandwich chemiluminescent immunoassay based on LOCI technology. The LOCI reagents include two synthetic bead reagents and one biotinylated anti-procalcitonin (anti-PCT) monoclonal antibody. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with two anti-PCT monoclonal antibodies and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-PCT-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the procalcitonin (PCT) concentration in the sample.

AI/ML Overview

The provided document describes the performance characteristics of the Dimension® EXL™ LOCI® BRAHMS Procalcitonin (PCT) assay and its equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Precision	Within-lab %CV: ≤ 10.0% for QC1, QC2, QC3, Serum 2, 3, 4, 5; ≤ 15.0% for Plasma, Serum 1.	Lot FB1218: QC1 (4.3%), QC2 (2.2%), QC3 (2.5%), Plasma (4.0%), Serum 1 (4.0%), Serum 2 (2.7%), Serum 3 (2.0%), Serum 4 (1.5%), Serum 5 (2.7%). All Pass.
Lot FC1218: QC1 (3.3%), QC2 (4.2%), QC3 (2.6%), Plasma (4.0%), Serum 1 (3.0%), Serum 2 (2.7%), Serum 3 (2.7%), Serum 4 (2.1%), Serum 5 (2.3%). All Pass.
	Total %CV: ≤ 10.0% for QC1, QC2, QC3, Serum 2, 3, 4, 5; ≤ 15.0% for Plasma, Serum 1.	Lot FB1218: QC1 (7.1%), QC2 (3.5%), QC3 (3.2%), Plasma (6.0%), Serum 1 (5.0%), Serum 2 (4.1%), Serum 3 (2.7%), Serum 4 (3.0%), Serum 5 (5.5%). All Pass.
Lot FC1218: QC1 (6.2%), QC2 (4.5%), QC3 (3.2%), Plasma (6.0%), Serum 1 (6.0%), Serum 2 (3.6%), Serum 3 (3.2%), Serum 4 (3.1%), Serum 5 (5.8%). All Pass.
Reproducibility	Total Reproducibility (CV%) for various PCT levels. (No explicit criteria mentioned in the document, but results are provided indicating good reproducibility).	MDP1 (0.10 ng/mL): 7.0%, MDP2 (0.25 ng/mL): 4.4%, MDP3 (0.48 ng/mL): 3.8%, MDP4 (1.95 ng/mL): 3.8%, MDP5 (8.94 ng/mL): 4.2%, MDP6 (41.01 ng/mL): 9.3%.
Detection Capability	LoB 10% interference at >1200 ng/mL. HAMA >10% interference at 32.5 mg/mL (HAMA 1) and 65.0 mg/mL (HAMA 1 and 2), Total Protein >10% interference at 15.0 g/dL.	Biotin: >10% interference at 1500 ng/mL (-19% bias at 1.88 ng/mL PCT) and 3510 ng/mL (-26% to -29% bias). HAMA 1: -10% to -12% bias at 65.0 mg/mL and -11% to -12% bias at 32.5 mg/mL. HAMA 2: -14% to -13% bias at 65.0 mg/mL and -11% bias at 32.5 mg/mL (at 2.19 ng/mL PCT). Total Protein: -18% bias at 15.0 g/dL. These led to specific labeling cautions.
Cross-Reactivity	No explicit criterion provided, only results of testing.	No significant cross-reactivity observed with Calcitonin (Human, Eel, Salmon), Katacalcin (Human), α-CGRP, and β-CGRP. For example, Human Calcitonin at 8 ng/mL showed 0.00% to -0.50% cross-reactivity.
Hook Effect	No hook effect for PCT concentrations up to 2000.00 ng/mL.	For patient specimens with PCT concentrations between 50.00 ng/mL and 2000.00 ng/mL the assay will report results as "Above Assay Range" (> 50.00 ng/mL).
Sample Carryover	No sample carryover from high to low samples.	Calculated to be 0.00 ng/mL. No sample carryover observed.
Method Comparison	Strong correlation (r), passing Deming/Passing-Bablok regression, high percentage agreement at clinical cutoffs with predicate device.	Measuring Interval (0.05-50.00 ng/mL):
Lot FB1218: r = 0.958, Slopes 1.07, Intercepts -0.01.
Lot FC1218: r = 0.963, Slopes 1.04, Intercepts 0.00 to -0.01.
Positive % agreement: 96.1-97.8%, Negative % agreement: 89.1-97.5%, Overall % agreement: 95.9-97.5% across various cut-offs (0.10, 0.25, 0.50, 2.00 ng/mL).
Extended Measuring Interval (0.05-1000.00 ng/mL):
Lot FB1218: r = 0.988, Slopes 1.08, Intercepts -0.01.
Lot FC1218: r = 0.991, Slopes 1.05, Intercepts 0.00 to -0.01.
Positive % agreement: 96.5-98.0%, Negative % agreement: 89.1-97.5%, Overall % agreement: 96.1-97.6% across various cut-offs. These results demonstrate substantial equivalence to the predicate device.
Matrix Comparison	No significant difference based on Passing-Bablok regression analysis between serum and plasma samples.	All specimen types (Serum (SST), Serum (RST), Lithium Heparin plasma, Sodium Heparin plasma, K2EDTA plasma, and K3EDTA plasma) showed high correlation coefficients (0.996-0.998) and regression equations close to y=x (slopes around 0.98-1.00, intercepts around 0.00-0.01 ng/mL) when compared to Serum (SST), indicating no significant difference.
Reference Interval Verification	Reference interval claim of

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