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Templates and downloads

In a study, Blank template (CSV) at the top of Set up and Data downloads a file with the study's column headings and no results, ready to fill in; the carryover template already lists the 21 positions and their roles. Each study type that takes an import also has an example file below with the same headings. To use one as a template, keep the header row, replace the rows with your own results and import it. The example data you can load come from these files, and the example study and project are described below.

Example files

Section titled “Example files”

All files are comma-separated UTF-8 with a decimal point, and the row counts leave out the header. The files show how entry and import work. Each linked study guide explains how many specimens, days, runs and replicates to collect.

File Study type Rows × columns What it contains
descriptive.csv Descriptive summary 5 × 6 Five results with IDs 00001 to 00005, one level, day and run
repeatability.csv Repeatability 21 × 8 One control material QC-001, 21 replicates in one run. One row, result 1004, is excluded as a transcription error
precision.csv Multi-day precision 25 × 6 One material QC1: 5 days × 1 run × 5 replicates
accuracy.csv Bias against an assigned value 10 × 4 Ten results for reference material CRM-1, all on day 1, run 1. Enter the assigned value on Set up
linearity.csv Linearity 15 × 5 Five expected concentrations (0, 25, 50, 100, 200) × 3 replicates
dilution.csv Dilution verification 7 × 9 Two high specimens HP-1 and HP-2, diluted in saline. Dilutions are given as volumes (100 + 400), a stated factor (5) and serial steps (5, 2)
comparison.csv Method comparison 20 × 4 20 specimens, comparative and test results in one row each
comparability.csv Instrument comparison 18 × 5 6 specimens at 3 levels, each measured on Analyzer A, Analyzer B and Analyzer C, one row per result
lots.csv Lot comparison 14 × 4 6 patient specimens and one QC material QC-1 on LOT-A and LOT-B. LOT-B is the new lot: on Set up, choose it under Which lot is in use now?
reference_verify.csv Reference interval verification 25 × 4 24 subjects in partitions adult (15 rows) and senior (10 rows). One subject has a second draw, replicate 2
reference_establish.csv Reference interval establishment 41 × 4 40 subjects in partitions female and male, one of them with a second draw. A small set for learning the steps
reference_establish_120.csv Reference interval establishment 240 × 4 120 subjects each in female and male, one result per subject
qualitative_agreement.csv Qualitative agreement 42 × 4 40 specimens with positive/negative results by both methods, some equivocal or invalid, and two repeat rows (replicate 2)
qualitative_cutoff.csv Near-cutoff precision 105 × 5 7 concentrations (6 to 13) × 3 days × 5 replicates, with positive, negative and equivocal results
detection_lob.csv Detection limits, LoB 40 × 8 Two blank materials BLK-A and BLK-B, 4 days × 5 replicates each
detection_lod.csv Detection limits, LoD 50 × 8 Two blank materials and three low materials (assigned 0.30, 0.40 and 0.55), 10 results each
detection_loq.csv Detection limits, LoQ 40 × 8 Four low materials assigned 0.5, 1, 2 and 4, 10 results each
carryover.csv Carryover 21 × 5 One complete 21-position run R1, low material LOW-01 and high material HIGH-01
carryover_21_template.csv Carryover 21 × 5 Blank template with the same 21 positions and roles and empty results
interference.csv Interference 48 × 6 Pools P1 and P2 at level low and P1 at level high, each with base, control (0) and test aliquots at 1, 2 and 5, three replicates each. Pool P2 at level high has test aliquots at 5 with no control
stability.csv Stability 80 × 5 5 specimens in duplicate: baseline at time 0, then Room temperature, unspun (2, 4, 8, 24) and Refrigerated, separated (4, 24, 72). The conditions are read from the file
qc-export.csv QC targets (QC export) 8 × 7 The seven QC export columns. Sodium, code NA, lot 00123, level 1, on P_CC_3 and P_CC_4 for three days each. Two censored <3.100 results for aHBs2 level Low on P_IM_4
calibration_verification.csv Calibration verification 9 × 3 Three levels × 3 replicates. Enter each level's independent assigned value or material range on Set up
pt_normal.csv PT and INR: normal mean 20 × 3 20 independent normal subjects, one PT result each, measured across 3 days
pt_programming.csv PT and INR: programming check 3 × 3 Three PT results with reported INR values. Enter the programmed mean normal PT and ISI on Set up
pt_lot_comparison.csv PT and INR: lot comparison 20 × 4 20 specimens with previous-lot and new-lot PT results, grouped as Normal, Therapeutic and High
glucose_error_grid.csv Glucose meter error grids 40 × 4 40 specimens with paired reference and meter results, all for Meter A
proficiency.csv Proficiency tracking 5 × 10 Five survey events with laboratory results, peer and all-method summaries, and provider grades; one peer SD is blank
uncertainty.csv Measurement uncertainty 6 × 5 Six materials with measured and assigned values, assigned uncertainties and coverage factors; add precision evidence on Set up

Sigma metric studies use entered or linked bias and imprecision values.

The example study

Section titled “The example study”

A single-run glucose repeatability study: one serum control, QC-001, measured 20 times, plus one result of 1004 excluded with a reason. It has two limits: mean within 2% of 100 mg/dL, and CV at most 0.8%.

Result Value
Included results 20 (1 excluded)
Mean 100.17 mg/dL
Repeatability SD 0.936 mg/dL
CV 0.93%
95% CI for mean 99.73–100.61 mg/dL
Mean near assigned target Met
Within-run imprecision Not met (0.93% against a limit of ≤ 0.8%)

The CV limit is strict on purpose, so the study status is Criteria not met.

The example project

Section titled “The example project”
Analyte Studies
C-reactive protein Descriptive summary
Creatine kinase Sample carryover (21-position sequence)
Glucose Repeatability; multi-day precision; bias check; method comparison; instrument comparison; reagent lot comparison; calibration verification; linearity; dilution verification; interference; stability; glucose meter error grid; proficiency tracking; measurement uncertainty; sigma metric
hCG, urine Qualitative agreement; near-cutoff precision
Prothrombin time Normal PT mean and intervals; INR programming; PT/INR lot comparison
Troponin I, high sensitivity Limit of blank; limit of detection; limit of quantitation
White blood cell count Reference interval verification; reference interval establishment by sex

Studies worth opening:

Study What it shows
Glucose · single-run repeatability The example study's data, signed off. The report reads Criteria not met.
Glucose · hemolysis interference Interference effect is not met for the low-glucose pools at 2 and 5 g/L hemoglobin and is Undecided at the high level, where only one pool has a matched control.
Glucose · analyzer comparability Corrected after sign-off, so it shows Results out of date. The signed report stays as it was.
Glucose · specimen stability A limit set for one storage condition, so it is Not applicable for the other.
hCG · qualitative agreement Undecided: 3 of 40 specimens have a nonreportable first result, so overall agreement can't be decided. The reportable pairs agree 91.9%.
Troponin I · limit of blank A result reported as <0.01, kept as text.
Glucose · derived sigma at 100 mg/dL Takes bias and imprecision from two other studies in the project.

Panel comparison files

Section titled “Panel comparison files”

Use these files with Compare a panel of analytes. Both layouts contain the same 20 specimens with glucose, sodium and potassium results from two methods.

File Rows × columns Layout
panel_wide.csv 20 × 7 Both methods side by side in one file
panel_reference.csv 20 × 4 Reference-method results; import together with the candidate file
panel_candidate.csv 20 × 4 Candidate-method results; import together with the reference file

Manual-only examples

Section titled “Manual-only examples”

Each of these files goes with an example in one chapter of this manual.

File Used in What it contains
qualitative_ordinal.csv Qualitative agreement 30 specimens with ordered grades negative, 1+, 2+, 3+ by both methods

Other downloads in the app

Section titled “Other downloads in the app”

From your own studies you can download: