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cobas EBV is an in vitro nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA in human EDTA plasma on the cobas 6800/8800 Systems.

cobas EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess response to treatment.

The results from cobas EBV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Negative test results do not preclude EBV infection or EBV disease. Test results must not be the sole basis for patient management decisions.

cobas EBV is not intended for use as a screening test for donors of blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Device Description

cobas EBV is a quantitative test performed on the cobas 6800 System and cobas 8800 System. cobas EBV enables the detection of EBV DNA in plasma specimens. The cobas EBV assay is a dual target assay, with both targets using the same dye. The DNA Internal Control, used to monitor the entire sample preparation and PCR amplification process, is introduced into each specimen during sample processing. cobas EBV enables the detection and quantitation of EBV DNA in EDTA plasma from solid organ transplant patients (SOT) and from hematopoietic stem cell transplant (HSCT) patients. The test is intended for use as an aid in the management of SOT patients and HSCT patients.

The cobas EBV consists of:

Proteinase Solution ●
DNA Quantitation Standard (DNA QS) ●
Elution Buffer ●
Master Mix Reagent 1
. EBV Master Mix Reagent 2

The EBV viral load is quantified against a non-EBV DNA quantitation standard (DNA-OS), which is introduced into each specimen during sample preparation. The DNA-QS also functions as an internal control for sample preparation and the PCR amplification process.

In addition, the test utilizes the following separately packed and sold control materials:

1. cobas EBV Positive Control Kit:
- . EBV Low Positive Control (EBV L(+)C)
- EBV High Positive Control (EBV H(+)C) ●

The positive control contains phage packaged EBV DNA in normal human plasma and serves as a control for the cobas EBV test.

1. cobas Negative Control Kit:
- cobas Buffer Negative Control (BUF (-) C) ●

Testing with the cobas EBV test requires the following materials that are not provided:

cobas OMNI Reagents: Including the following reagents used for specimen ● processing, PCR and detection:
cobas EBV Assay Specific Analysis Package (ASAP) software .

The cobas EBV test uses sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection, all steps are fully automated by the cobas 6800/8800 platform.

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Reported Device Performance
Precision	Standard Deviation (log10 transformed titer): Ranged from 0.02 to 0.17 across various concentrations (Table 1).
Lognormal Percent Coefficient of Variation (%CV): Ranged from 7% to 43% for positive panel members (Table 2).
Reproducibility	Total Lognormal Coefficient of Variation (% CV): Ranged from 13.7% to 46.16% among positive panel members when tested across three reagent lots, three test sites, and three instruments (Table 3).
Linearity (Genotype 1)	Linear Range: 35 IU/mL (LLoQ) to 1.0E+08 IU/mL (ULoQ).
Accuracy: Within ± 0.15 log10 IU/mL (Mean Square Error) across the linear range.
Best-fitting model: 1st order for individual lots/panel types, 2nd order for combined data (minor difference to 1st order: ≤ ± 0.01 log10 IU/mL). (Table 4, Figure 1)
Linearity (Genotype 2)	Accuracy: Within ± 0.12 log10 IU/mL (Mean Square Error) across the linear range, with minor differences (–0.06 log IU/mL to +0.08 log IU/mL) between 1st and 3rd order regression models. (Figure 2)
Traceability	Quantitation values for the cobas EBV calibration panel and RMS EBV Secondary Standard showed deviations not more than 0.15 log10 IU/mL from expected values, demonstrating traceability to the 1st WHO International Standard for EBV (NIBSC 09/260). (Figure 3)
Regression equations: EBV Calibration Panel: y = 1.000x - 0.002; R2 = 1.000.
EBV 1st WHO Standard: y = 0.975x + 0.159; R2 = 0.983.
Clinical Specimen Stability	Whole blood (EDTA-plasma tubes) stable for up to 24 hours at 2-25°C. Plasma stable for 24 hours at 2-30°C, then up to 6 days at 2-8°C, or up to 6 months at -15 to -80°C. Plasma stable for up to four freeze/thaw cycles. Mean log10 titers at different time points/conditions were within ±0.5 log10 of the reference (T0).
Open Kit and On-board Stability	Open test-specific reagent cassettes stable for up to 90 days at 2-8℃ (Open Kit) and up to 40 hours at 37°C (On-Board). Reusable for up to 40 runs.
Reagent Stability	Shelf-life stability claim of 12 months when stored at 2-8°C (supported by real-time stability data).
Limit of Detection (LoD)	WHO EBV Standard (Genotype 1): LoD = 18.8 IU/mL by Probit analysis (highest LoD across lots). LoD by 95% hit rate was (b) (4) for all lots. (Table 5)
EBV Genotype 2: LoD verified at 18.8 IU/mL with a hit rate of 95% or higher. (Table 6)
Plasma vs Buffer (GSD): Comparable LoD performance in Plasma and GSD (Hit rate 98.4% at 1.5xLoD, 92.1% at 1.0xLoD). (Table 7)
Lower Limit of Quantitation (LLoQ)	LLoQ: 35 IU/mL. Determined based on Total Analytical Error (TAE) and difference between two measurements. (Table 8)
Cross-reactivity	EBV-negative samples: Negativity rate was high (not explicitly stated as 100% but implied by lack of reported positives).
EBV-positive samples: Mean log10 titer of positive EBV samples with 35 potential cross-reacting microorganisms was within ±0.5 log10 of the positive spike control. (Table 9)
Endogenous Interference	EBV-negative samples: All produced valid negative results.
EBV-positive samples: Mean log10 titer of positive EBV samples with interfering substances (NaOH2, Albumin, Bilirubin, Human DNA, Hemoglobin, Triglycerides) was within ±0.05 log10 of the spike control. (Table 10)
Exogenous Interference	EBV-negative samples: 100% negativity rate.
EBV-positive samples: Mean log10 titer of positive EBV samples with 24 common drugs was observed to be within acceptable range (implied by table values, e.g., Max Mean Difference in log10 Titer of -0.03 for Ethanol SC). (Table 11)
Cross-Contamination	0% cross-contamination rate (upper one-sided 95% CI: 1.24%) from testing 240 replicates of EBV-negative matrix sample in checkerboard configuration with high-titer samples.
Concordance with Comparator EBV Test	Overall Column Percent Agreement: Ranged from 82.5% to 100% depending on analyte concentration (for valid samples on both assays, n=464). (Table 12)
Negative Percent Agreement (NPA): 95.4% (95% CI: 84.2%-99.4%) with comparator EBV negative samples (n=43).
Agreement at clinical thresholds: High agreement, e.g., 98.0% (

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