Evidence map›Paper›PMID 41530473›Full record

ReviewThe AAPS journal2026

Best practices in the application of parallelism for biomarker assay validation.

Lindsay King, John Allinson, Lakshmi Amaravadi, Robert Kernstock, Fabio Garofolo, Michele Gunsior, Barry Jones, Joel Mathews, Robert Neely, Robert Nelson and 4 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Lindsay KingPfizer Inc, Translational Clinical Sciences, 610 Main Street, Cambridge, Massachusetts, 02139, USA. Lindsay.king@pfizer.com.ORCID 0009-0005-3749-1522
John AllinsonImmunologix Laboratories, Tampa, Florida, 33634, USA.ORCID 0000-0002-9375-8026
Lakshmi AmaravadiAstraZeneca, Waltham, Massachusetts, 02451, USA.ORCID 0009-0008-1720-3249
Robert KernstockAstellas Research Institute of America, LLC, Northbrook, Illinois, 60062, USA.ORCID 0000-0002-3984-9138
Fabio GarofoloBRI Frontage, Vancouver, British Columbia, V6P 3S8, Canada.ORCID 0009-0002-6929-9357
Michele GunsiorAstria Therapeutics, Boston, Massachusetts, 02210, USA.ORCID 0000-0002-6086-5968
Barry JonesCrinetics Pharmaceuticals Inc., San Diego, CA, 92121, USA.ORCID 0009-0008-8421-8272
Joel MathewsIonis Pharmaceuticals, Carlsbad, California, 92010, USA.ORCID 0000-0002-5535-8080
Robert NeelyImmunologix Laboratories, Tampa, Florida, 33634, USA.ORCID 0009-0000-5619-0163
Robert NelsonBioAgilytix Laboratories, 22339, Hamburg, Germany.ORCID 0009-0004-9144-1182
Marc-Olivier PepinCharles River Laboratories, Senneville, Quebec, Canada.ORCID 0009-0001-8050-8394
Honglue ShenMerck & Co., Inc., Boston, MA, 02115, USA.ORCID 0009-0005-9021-9114
Lauren StevensonImmunologix Laboratories, Tampa, Florida, 33634, USA.ORCID 0009-0001-3103-3150
Troy VoelkerAliri Bioanalysis, Colorado Springs, Colorado, 80907, USA.ORCID 0009-0007-5421-8039

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An assessment of parallelism is critical for biomarker assays to confirm whether the assay recognizes the endogenous analyte similarly to the calibrator, the suitability of a surrogate calibrator matrix and the potential need for a minimal required dilution. While the importance of parallelism has been raised in numerous publications there remains a lack of detail on how to conduct and interpret parallelism experiments, as well as some confusion between parallelism, dilution linearity, and spike recovery experiments. This best practice paper provides a detailed discussion of the reasons for conducting parallelism, as well as recommendations for when to conduct parallelism experiments, the number of samples needed, the selection of appropriate surrogate matrices, the interpretation of parallelism data, including graphical and statistical methods, and parallelism results reporting. It emphasizes the need for continuous evaluation of parallelism throughout the assay life cycle to ensure reliable measurement of the desired analyte within the context of use. Finally, a number of short case studies are provided to illustrate the application and interpretation of parallelism.

Indexed as

Biological AssayBiomarkersPractice Guidelines as TopicCalibrationHumansReproducibility of ResultsBiomarkersbest practicebiomarkercalibratorparallelism

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.