Exhibit 1 Technical Evaluation Checklist - Factor C (Fentanyl) (002).docx

REAGENT FOR THE DETECTION OF FENTANYL

TECHNICAL EVALUATION FACTOR C

N62645-20-R-0005

Technical Evaluation for ______________________________ (Company Name)

Evaluation Factor C – Performance Test (Best Value/Trade Off)

Instructions to Evaluator: The overall performance of each vendor reagent will be assigned a performance rating by NMLC, based on the results of the comments the evaluator provides below. Please assign a Performance indicator for each Element. In the “Narrative” field for each Element, please indicate the objective test results and your justification for the assigned Performance indicator.

1. Previously confirmed and archived fentanyl positive specimens that are authorized for disposal shall be re-confirmed as positive (fentanyl at or above the 1 ng/mL confirmation cut-off) and analyzed by immunoassay. At least 20, but no more than 100, positive specimens shall be analyzed with water blanks between each specimen.

1.1. 95% of the specimens should be correctly identified as positive by the offeror’s immunoassay reagent for the presence of fentanyl or norfentanyl (utilizing the DoD initial screen cutoff concentration of 1 ng/mL).

1.1 Narrative:

2. Approximately 2,000 specimens, submitted to the FTDTL for routine testing, shall be analyzed by immunoassay.

2.1. 100% of the 0% QC samples should screen negative and provide values less than the mean of the 50-75% QC samples both within runs and between runs.

2.1 Narrative:

2.2. 95% of the 50-75% QC samples should screen negative.

2.2 Narrative:

2.3. 97.5% of the 150-200% QC samples should screen positive.

2.3 Narrative:

2.4. An enhancing factor is the ability to correctly identify positive and negative specimens. During the evaluation of offeror reagents, specimens that yield a positive fentanyl/norfentanyl initial screen result shall be confirmed by Gas Chromatography-Mass Spectrometry (GC-MS) or liquid chromatography–mass spectrometry (LC-MS/MS). The discriminatory ability of the reagent to correctly identify confirmed negative and confirmed positive specimens (fewer false positives and fewer false negatives) shall increase the value of the reagent kit.

2.4 Narrative:

3. Precision/Accuracy, Linearity, and Calibration Stability of the fentanyl reagent shall be evaluated based on an analysis of 20 replicates of QC samples at target concentrations of 0%, 50%, 75%, 100%, 125%, 150%, and 200% of the CAL/cutoff analyzed at 0 hours, 4 hours, and 8 hours after calibration.

3.1. There should be a positive correlation for the slopes (i.e., increasing concentrations result in increasing values) of the lines drawn between the mean replicate values of the 0% through 150% concentrations.

3.1 Narrative:

3.2. Individual replicates at 0%, 50%, 100%, and 150% should demonstrate a distinctive range of values with no overlap with adjacent concentrations.

3.2 Narrative:

3.3. The coefficients of variation (CVs) of the 20 replicate values at 75%, 100%, 125%, 150%, and 200% of the CAL should be less than 10% within each run and less than 15% within the three timed runs.

3.3 Narrative:

4. The effect/interference of endogenous matrix components, commonly encountered compounds, and compounds that are structurally similar to the analytes of interest on the immunoassay response shall be evaluated by spiking drug-free urine with potentially-interfering analytes in the table below. Cross-reactivity will be evaluated according to the response values.

4.1. An enhancing factor is a low cross reactivity with the interference study analytes. Better specificity (lower/negative response values for non-analyte of interest specimens) will increase the rating of the enhancing factor

4.1 Narrative:

FOR SOURCE SELECTION INFORMATION, SEE FAR 3.104