Watermarked public demonstration

Test the laboratory reporting workflow

Choose an instrument module and assay configuration, confirm the current manufacturer range, apply CLIA reference or local SOP criteria, enter synthetic results, and inspect a structured report preview.

Do not enter patient names, accession numbers, dates of birth or protected health information.This demonstration processes entries in your browser. Export and printing are disabled.
Public demonstrationUse synthetic, deidentified data only. Reports are watermarked previews and export is disabled.
1 Study2 Criteria3 Data4 Draft report

Choose the report product

Configure the study

All 70 quantitative analytes in the current CLIA routine chemistry, endocrinology and toxicology tables are included. Choose the chemistry or immunoassay module for your study. Blood gases and blood lead have separate configurations. Lipid studies include total cholesterol, HDL, triglycerides and directly measured LDL. Calculated LDL, VLDL, non-HDL and ratios are derived results, not independently measured assays; they do not inherit the direct-LDL PT limit or an analyzer AMR. Verify the selected calculation separately.

Linearity / AMRAssess assigned versus observed results across the proposed analytical measurement range.
Method configurationHexokinasePlatform-linked planning default; confirm the current lot-specific IFU.

Set the evaluation criteria

CLIA PT reference criterion±6 mg/dL or ±8%, whichever is greaterCLIA PT reference reviewed October 14, 2026. Not an automatic validation or clinical decision limit. View criterion source Absolute limits are scaled to the selected reporting unit. Changing units clears entered ranges and data to avoid mixing units.

Enter deidentified results

For linearity, enter expected and observed values. For comparison, use comparator and candidate-method results. Do not enter patient identifiers.

#ExpectedObservedDifferenceStatus
10.40Within
2-0.50Within
31.20Within
4-2.20Within
54.10Within

EMI / dilution verification demo

Enter your current method configuration. No manufacturer AMR or dilution claim is assumed. This is a numerical screening pilot, not a final validation approval.

Selecting an assay does not establish a dilution claim. Enter the current IFU range, permitted dilution, and approved local EMI criteria.

Every replicate is a separate run. Use the same deidentified study ID to group replicates. Enter an independent target only when its source is documented.

Run 1
Run 2
Run 3
ASSAYIQ GLOBAL | WATERMARKED DEMONSTRATION

Extended Measurement Interval | Methotrexate (MTX)

[FACILITY NAME] | Methotrexate (MTX) | µmol/L

DIRECTOR REVIEW REQUIRED
DEMO ONLY • NOT FOR CLINICAL USE
InstrumentNot recorded
SpecimenSerum
Direct AMR– µmol/L
Proposed upper EMI µmol/L
Current IFUNot recorded
QC / calibration / lotsNot recorded
Diluent / preparationNot recorded
Local criteriaCV ≤10%; bias/deviation ≤20%

Specimen-level analytical summary

Study IDnMeanSDCV %Assigned targetBias %Max deviation %Screen

Add eligible replicates to display the dilution study chart.

Interpretation and director action

3 run(s) excluded from calculations; all remain on the attached worksheet. Without an independent assigned/comparator target, this screen assesses repeatability only, not accuracy or dilution recovery. Conflicting targets require reconciliation. A theoretical AMR × dilution factor is not a validated reporting limit.

The proposed limit is not automatically approved. Confirm endpoint coverage, traceable target assignment, dilution preparation, instrument correction behavior, QC, current IFU permissions, specimen matrix, local SOP, reporting comments and LIS build. MTX interpretation depends on the treatment protocol and collection timing.

References and controlling documents

42 CFR §493.1253: performance specifications; §493.1283: test records. Apply the current manufacturer IFU and approved local SOP: Not supplied; verification required.

DEMONSTRATION ONLY | NOT FOR CLINICAL USE | Attached worksheet forms part of this report.
ASSAYIQ GLOBAL | ATTACHED WORKSHEET | DEMO ONLY

EMI dilution and target-result worksheet

[FACILITY NAME] | Methotrexate (MTX) | µmol/L

Date/time: Not recorded

Performed by: Not recorded

Storage / target source: Not recorded

Result basis: direct

LineStudy IDOriginal resultManual DFOnboard DFEntered resultCorrected resultTargetScreen
111Not estimableNoneExcluded / range review
211Not estimableNoneExcluded / range review
311Not estimableNoneExcluded / range review

Required supporting records

□ Study IDs traceable □ Specimen acceptable □ Diluent/volumes recorded □ Current IFU reviewed □ QC verified □ Printouts retained □ Comparator target traceable or no target documented □ Deviations reviewed

Corrected result = direct measured result × manual DF × onboard DF only when the entered result has not already been dilution-corrected. Already-corrected results are never multiplied again. Nonquantitative results are retained, not treated as numeric values. Grouping uses the entered study ID; use distinct IDs for distinct materials or concentrations.

Deviations / corrective actions: ______________________________________________________________

Approved upper reporting limit and dilution procedure: __________________________________________

Performed by

Name/signature: __________________

Date: __________________

Technical review

Name/signature: __________________

Date: __________________

Director approval

Name/signature: __________________

Date: __________________

Worksheet format 1.1 | Retain with report, instrument records, QC evidence and approved dilution procedure.

Watermarked preview only. Public downloads and printing remain disabled. The private controlled output includes both the report and its worksheet.

How this demonstration works

Test the workflow without receiving the production software.

Instrument-linked menus

Browse grouped chemistry, immunoassay and toxicology configurations. The full CLIA catalog is also available for manual mapping after local compatibility confirmation.

IFU confirmation gate

Manufacturer intervals remain editable and require explicit confirmation because claims may vary by reagent and region.

Two acceptance layers

The preview preserves the CLIA reference criterion and records a laboratory-specific SOP limit when used.

Protected preview

The public report remains visibly watermarked and cannot be downloaded or printed from the application.