When a result exceeds the analyzer’s range, the evidence should not stop there.

More useful results, with a controlled process.

A result reported only as “greater than” a limit may leave the provider without the quantitative information needed to follow a trend. Where the current method permits it and the laboratory has established the necessary evidence, dilution can support a reportable numerical result. Clinical use still depends on the assay and the patient’s care protocol.

MTX, CK/CKT and hCG need their own study designs.

The arithmetic is simple. The evidence is not. Confirm the assay, specimen type, diluent, manual and onboard dilution factors, instrument correction behavior and current manufacturer instructions. For MTX, interpretation depends on the treatment protocol and collection timing. For hCG, evaluate applicable high-dose hook-effect precautions. CK results must be considered with the clinical context. This service does not provide treatment recommendations.

A dilution multiplier is not a verified upper limit.

Multiplying the direct upper limit by a dilution factor gives a theoretical concentration, not proof of acceptable performance at that concentration. The approved protocol should address endpoint coverage, accuracy or recovery using suitable targets, precision and local acceptance limits. Consistent repeated results without an independent target establish repeatability, not accuracy.

What the director receives.

AssayIQ’s pilot records dilution factors, direct versus already-corrected results, targets, run dates, personnel and deviations. It calculates specimen-level means, sample SD, CV and target bias where supported. Each report is paired with a run worksheet and review signatures. Excluded or nonquantitative entries remain visible. Qualified review is required before any change to the reporting interval or LIS configuration.

Make fewer avoidable repeats. Preserve the evidence.

A clear dilution workflow can reduce handoffs, transcription errors and unnecessary repeat work. Savings are measured against the laboratory’s actual repeats, labor and materials; they are not guaranteed. AssayIQ can help scope the study, review the evidence and support implementation within the laboratory’s approved compliance framework.

Try the EMI pilot Discuss a managed EMI study

Sources and local controls

42 CFR §493.1253 covers applicable performance verification or establishment and documentation. §493.1283 addresses test records. These sections do not prescribe a universal EMI CV or bias limit. The current manufacturer IFU, applicable accreditation requirements and approved local SOP govern the study design. Sources reviewed October 7, 2026.