Essential Quality Metrics for Immune Cell Biospecimens in Translational Research

Photo Credit: National Institute of Allergy and Infectious Diseases (NIAID)

Immune cell biospecimens are the cornerstone of modern immunological research. They offer unmatched insight into cellular function, therapeutic development, and disease mechanisms. But how intact and pure these materials are directly affects experimental reproducibility and data interpretation. Ultimately, it determines whether translational research succeeds.

Multi-parameter flow cytometry, single-cell sequencing, and functional assays keep getting more advanced. As they do, demand for rigorously characterized biospecimens keeps growing. Moving from basic research to clinical applications requires biospecimens that meet strict quality standards across several parameters.

Whether you’re developing next-generation CAR-T therapies, investigating new oncology biomarkers, or profiling immune responses in infectious disease, you need to think about several factors. These include cell viability, phenotypic stability, functional competence, and annotation quality. At Sanguine, our direct-to-donor model and thorough QC protocols ensure specimen quality. Every specimen — from Human PBMCs to specialized Human CD56+ NK Cells — meets the standards required for publication-quality research and regulatory submissions.

Understanding Critical Quality Parameters for Immune Cell Products

Cell viability is the fundamental quality metric for all immune cell biospecimens, but it’s only the starting point. Post-thaw viability for cryopreserved Human PBMCs should consistently top 85% when measured by trypan blue exclusion or 7-AAD flow cytometry within 24 hours of thawing.[1] Viability alone doesn’t guarantee functional competence — cells may exclude vital dyes yet still show weak proliferation, cytokine production, or receptor expression.

Functional viability assessments give you a fuller picture of cellular health. For Human CD3+ T Cells, stimulation assays using anti-CD3/CD28 beads should show strong proliferation and cytokine secretion (IL-2, IFN-γ, TNF-α) comparable to freshly isolated cells.[2] Similarly, Human CD56+ NK Cells must keep their cytotoxic function against standard target lines (K562). Specific lysis should stay above 40% at 10:1 effector-to-target ratios after cryopreservation.[3] These functional benchmarks confirm that your downstream results reflect true biology, not processing artifacts.

Phenotypic stability is another essential dimension, especially for multi-parameter immunophenotyping. Improper handling, extended processing times, or suboptimal cryopreservation can significantly change surface marker expression. When you work with Human Leukopak preparations, check the major subsets — CD4+ T cells, CD8+ T cells, B cells, NK cells, and monocytes. Confirm they keep their expected proportions and marker profiles after processing.[4] Sanguine’s standardized protocols include thorough immunophenotyping data with every cellular product.

Quality Control in Apheresis-Derived Products

Human Leukopak products offer excellent cellular yields but need rigorous quality checks for consistency. Total nucleated cell (TNC) counts should fall within predefined ranges (typically 1–5 × 10^10 cells per standard leukapheresis). Mononuclear cell enrichment should stay above 90% after density gradient centrifugation.[5] Red blood cell contamination needs to stay minimal, since it can cause oxidative stress and hemoglobin-related interference in colorimetric assays.

The apheresis collection process itself introduces variables that affect quality. Anticoagulant choice (ACD-A, sodium citrate, or heparin) affects how well later isolation and functional assays perform.[6] Processing time from collection to cryopreservation shouldn’t exceed 24 hours for the best viability. Some protocols do extend this window with media supplementation and temperature control. Sanguine’s same-day collection and shipping protocols keep delays to a minimum, preserving function and reducing activation-induced changes.

Clinical-grade materials must meet extra standards, including sterility testing, mycoplasma screening, endotoxin quantification, and full batch documentation.[7] These enhanced specifications support IND-enabling studies and clinical trial applications where regulatory compliance is essential. Our custom collection services accommodate study-specific requirements, from specialized protocols to tailored QC panels.

Plasma and Serum Quality Considerations

Blood-derived biofluids are essential for biomarker discovery and validation, and their quality depends heavily on how they’re handled before analysis. Human Plasma collected in EDTA, citrate, or heparin tubes shows distinct protein stability profiles that affect downstream proteomic, metabolomic, and cytokine analyses.[8] Hemolysis — the rupture of red cells during collection or processing — introduces intracellular proteins and can artificially raise many analytes, confounding interpretation.

Processing time is a critical variable in plasma quality. Platelets activate quickly after venipuncture, releasing proteins and bioactive molecules that alter the biological profile.[9] Centrifuging within 2 hours of collection works best for most applications, though specific questions may call for different handling. Human Serum preparation involves an intentional clotting step. This step produces a biofluid depleted of coagulation factors but enriched in clot-derived proteins — helpful for certain immunoassays but potentially confounding for others.

Freeze-thaw cycles dramatically affect biofluid quality. Each cycle can degrade fragile proteins, activate proteases, and change metabolite concentrations. Single-aliquot strategies minimize freeze-thaw exposure but require careful volume planning up front. Sanguine’s thorough genomic annotation comes with every plasma and serum sample, documenting collection conditions, processing times, anticoagulant type, and storage history.

Whole Blood: Fresh and Cryopreserved Considerations

Human Whole Blood is the most physiologically relevant specimen for certain applications, since it keeps cell-cell interactions and natural cellular ratios intact. Fresh whole blood enables real-time functional assays — phagocytosis, oxidative burst, and degranulation — that require intact cellular interactions.[10] But whole blood has limited stability. Cells can activate and change their gene expression within hours of collection.

Anticoagulant choice strongly affects whole blood assay performance. EDTA binds calcium and blocks most coagulation factors but can affect certain surface markers. Heparin preserves calcium-dependent processes but may interfere with PCR-based assays. Sodium citrate offers a middle ground for many applications but dilutes the specimen by 10%.[11] Match your anticoagulant choice to both the cellular function you need and downstream analytical compatibility.

Temperature control during transport is another critical variable. Lymphocyte activation cascades kick in at elevated temperatures, altering gene expression and surface marker density.[12] Overnight ambient shipment may work for some assays but proves suboptimal for sensitive gene expression studies. Sanguine’s temperature-controlled logistics and same-day delivery get specimens to you within hours of phlebotomy.

Sample Annotation: The Often-Overlooked Quality Dimension

High-quality genomic annotation turns biospecimens from anonymous materials into powerful, reproducible research tools. Physician-confirmed diagnoses give you confidence in disease classification, while detailed medication histories let you account for therapies that influence immune profiles.[13] Demographic information — age, sex, ethnicity, BMI — enables stratification and lets you investigate population-specific mechanisms.

Electronic medical record (EMR) integration gives you access to longitudinal clinical data, including lab values, imaging, treatment responses, and disease progression markers. This depth matters especially in oncology biospecimens, where tumor stage, histological subtype, and treatment history strongly shape immune cell phenotypes.[14] Patient-reported outcomes (PRO) data add another dimension, capturing symptom burden, quality of life, and treatment adherence that medical records often miss.

Infectious disease status documentation goes beyond serology to include viral load, CD4+ counts (for HIV studies), vaccination history, and pathogen exposure timelines.[15] This level of annotation is what separates providers who simply collect samples from those who deliver complete research solutions. Sanguine’s direct-to-donor model across the United States gives researchers access to detailed medical histories and patient-reported data, supporting sophisticated multi-variable analyses.

Critical Quality Metrics Checklist for Immune Cell Biospecimens

Pre-Acquisition Assessment Criteria

When you evaluate potential biospecimen sources, systematically assessing a provider’s capabilities helps ensure the sample quality matches your experimental requirements. Below are minimum quality standards for translational research.

Cellular Product Quality Standards:

• Post-thaw viability ≥85% by trypan blue or flow cytometry (7-AAD/PI exclusion)
• Functional viability confirmed by antigen-specific stimulation assays
• Phenotypic stability verified by flow cytometry across major immune subsets
• TNC counts documented with coefficient of variation data
• RBC contamination <5% for enriched products
• Sterility testing completed (negative bacterial/fungal cultures)
• Mycoplasma screening performed (negative by PCR)
• Endotoxin quantification <0.5 EU/mL for sensitive applications
• Cryopreservation medium composition disclosed
• Processing time from collection to preservation documented

Biofluid Quality Standards:

• Hemolysis index <0.5 g/L free hemoglobin
• Lipemia assessment and documentation
• Icterus evaluation when relevant
• Centrifugation protocol specified (g-force, duration, temperature)
• Processing time from venipuncture documented
• Anticoagulant type clearly identified
• Freeze-thaw cycle history tracked
• Storage temperature verification
• Aliquot volume and concentration specified
• Platelet count for plasma specimens

Genomic Annotation Requirements:

• Physician-confirmed diagnosis with ICD-10 codes
• Disease duration and stage classification
• Current medication list with dosages
• Vaccination history (recent 6 months minimum)
• Comorbidity documentation
• Infectious disease serological status
• Demographic data (age, sex, ethnicity, BMI)
• Relevant laboratory values (CBC, chemistry panel)
• Smoking status and substance use history
• Family history for genetic conditions

Post-Acquisition Verification Protocols

Once a specimen arrives, systematic quality verification protects your research investment and confirms validity. Even specimens from qualified providers benefit from third-party validation before you commit them to labor-intensive or costly downstream applications.

Immediate Assessment (Within 24 Hours):

• Visual inspection for particulate matter or discoloration
• Verify specimen labeling matches documentation
• Confirm storage temperature during transit
• Assess packaging integrity and documentation completeness
• Perform initial cell count and viability assessment
• Document receipt condition with timestamped photographs
• Aliquot samples for quality control testing before main experiment
• Test one aliquot before processing entire batch

Functional Validation:

• Thaw and culture aliquot for 24–48 hours
• Assess proliferation capacity under stimulation
• Verify cytokine production by ELISA or multiplex immunoassay
• Confirm cell surface marker expression by flow cytometry
• Test in pilot functional assay representing main experiment
• Document baseline activation state markers (CD69, CD25, HLA-DR)
• Assess cell morphology by microscopy
• Compare to positive control (matched healthy donor specimen)

Documentation and Traceability:

• Maintain complete chain-of-custody records
• Document all quality control assessment results
• Record storage locations and conditions
• Track freeze-thaw cycles if applicable
• Photograph specimen appearance at key timepoints
• Maintain electronic laboratory notebook entries
• Archive representative aliquots for future validation
• Retain vendor certificates of analysis

Emerging Quality Metrics in Single-Cell and Spatial Technologies

Single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics have taken off quickly, and they bring new quality requirements beyond traditional viability metrics. Cell membrane integrity becomes critical, since compromised membranes lead to ambient RNA contamination and artifactual gene expression signatures.[16] The percentage of mitochondrial reads in scRNA-seq datasets is a sensitive sign of cellular stress or membrane damage. Healthy samples typically show under 10% mitochondrial content.

Nuclear integrity matters more and more for single-nucleus RNA sequencing (snRNA-seq). Isolating nuclei from frozen biospecimens requires careful optimization to avoid fragmentation while minimizing cytoplasmic contamination.[17] For Human Skin Punch Biopsy specimens intended for spatial transcriptomics, preserving tissue architecture and RNA quality (RIN scores ≥7) is critical for high-resolution mapping.

Doublet rates in single-cell preparations significantly affect data quality and analytical complexity. Optimal single-cell suspensions show doublet rates below 5%, though this varies by cell type and method.[18] It’s a smart strategy to validate single-cell suspension quality through pilot runs before committing precious biospecimens to expensive sequencing. Sanguine’s custom processing can optimize cell isolation for specific single-cell applications, minimizing technical artifacts.

Quality Economics: The True Cost of Suboptimal Biospecimens

Poor quality carries financial costs that go far beyond the purchase price. Failed experiments from low-viability or functionally compromised specimens waste expensive reagents, eat up personnel time, and delay timelines.[19] Consider a $500 PBMC sample that requires $5,000 in reagents, $2,000 in labor, and 3 weeks of experimental time. The true cost of a failed experiment on that sample approaches $7,500 — fifteen times the specimen cost.

This quality-cost relationship shows up even more starkly in clinical development, where failed manufacturing runs or invalidated trial specimens carry six- or seven-figure consequences. Using starting material that meets comprehensive specifications reduces process development risk and supports regulatory filing success.[20] The extra cost of premium-quality biospecimens is often less than 5% of total project costs, while it dramatically cuts technical risk.

Researchers are increasingly concerned about a reproducibility crisis. This has sharpened scrutiny of specimen quality as a confounding variable. Publications increasingly require detailed provenance documentation — collection methods, processing protocols, storage conditions, and QC data.[21] Researchers who set rigorous quality standards from the start of a project protect themselves from future reproducibility challenges and strengthen their translational relevance.

Sanguine’s Quality Assurance Framework

Our comprehensive quality management system covers every phase of the biospecimen lifecycle, from donor recruitment through delivery. Direct relationships with over 70,000 donors across the United States give us access to diverse patient populations while keeping standards consistent.[22] Every specimen goes through multi-parameter QC testing, with results documented in certificates of analysis that come with each shipment.

Standardized processing keeps quality consistent lot-to-lot, whether researchers order Human Whole Blood, Human Plasma, or isolated cellular products. Temperature-controlled logistics maintain cold-chain integrity from collection through delivery, with real-time tracking. Custom collection services accommodate study-specific requirements, from non-standard anticoagulants to specialized processing.

Thorough genomic annotation makes biospecimens far more useful than simply providing raw material. Physician-confirmed diagnoses, detailed medication histories, and patient-reported outcomes turn anonymous samples into phenotypically rich resources.[23] This depth matters especially for infectious disease biospecimens, where pathogen exposure history, vaccination status, and treatment regimens significantly shape immune cell phenotypes.

From study design to receipt of samples, our team works with researchers to identify the best collection strategies, processing protocols, and QC parameters. This consultative approach has supported over 500 research programs across academic institutions, pharmaceutical companies, and biotechnology firms.

Best Practices for Quality-Focused Biospecimen Procurement

Strategic Vendor Selection Criteria

Finding providers who prioritize quality over volume takes a systematic evaluation across multiple dimensions. Price per sample should never be your only criterion. The total cost of ownership — including failed experiments, repeated assays, and delays — often makes premium-quality specimens the most economical choice.

Essential Provider Capabilities:

• ISO certification demonstrating quality management systems (ISO 9001:2015, ISO 13485:2016)
• Documented standard operating procedures for all collection and processing steps
• Third-party validation of viability and functional metrics
• Transparent disclosure of processing timelines and conditions
• Comprehensive certificates of analysis with each shipment
• Direct-to-donor model enabling detailed medical history access
• Flexible custom collection capabilities for study-specific requirements
• Regulatory compliance documentation (IRB, HIPAA, 21 CFR Part 11)
• Temperature-controlled logistics with real-time tracking
• Scientific support team with immunology expertise
• Published validation data and customer testimonials
• Lot-to-lot consistency demonstrated across multiple shipments

Red Flags in Biospecimen Procurement:

• Vague or missing quality control data
• Inability to provide processing timelines
• Generic “De-identified Donor Data” without specific fields
• No physician confirmation of diagnoses
• Unclear specimen provenance
• Absence of regulatory compliance documentation
• Poor communication or scientific support
• Extremely low pricing suggesting quality compromises
• No validation data available
• High minimum order quantities forcing overbuy
• Inflexible processing protocols
• Limited annotation depth

Matching Sample Quality to Research Applications

Different applications call for different quality thresholds. Over-specifying unnecessarily drives up costs; under-specifying risks failure. Flow cytometry immunophenotyping can tolerate lower viability (≥75%) than adoptive transfer studies, which require ≥90% viable cells.[24] Understanding what each application actually requires lets you make smart quality-cost tradeoffs.

Basic mechanistic studies using established protocols can use standard-quality biospecimens with conventional metrics. Clinical biomarker validation aimed at regulatory submission needs enhanced documentation, including donor identity protection, full informed consent, and comprehensive compliance records.[25] Therapeutic development falls somewhere in between, requiring functional validation but not necessarily full GMP compliance until you reach clinical manufacturing.

Let “fitness for purpose” guide your selection. A high-throughput drug screen testing thousands of compounds may prioritize cost and availability, accepting 75–80% viability if cell numbers stay sufficient.[26] On the other hand, manufacturing patient-specific CAR-T products for early-phase trials demands ≥95% viable cells with documented sterility and comprehensive QC at every step. Matching specimen quality to what your application actually needs optimizes both your science and your budget.

Geographic and Demographic Diversity in Quality Assessment

Population diversity is a quality dimension that’s easy to overlook. Immune cell phenotypes, frequencies, and functional capacities vary significantly across demographic groups because of genetic background, environmental exposures, and comorbidity patterns.[27] Research conducted only on limited demographic groups may produce findings that generalize poorly, or miss population-specific therapeutic opportunities.

Sanguine’s donor network spans the United States, giving researchers access to demographically diverse populations, including underrepresented ethnic groups, rural communities, and patients with complex comorbidities. This breadth supports health equity research and strengthens translational relevance. For oncology biospecimens, access to diverse cancer patient populations lets researchers investigate ethnic disparities in treatment response and survival.

Quality assessment protocols should include demographic representation checks, confirming that experimental cohorts match your target population’s characteristics. This matters especially for biomarker validation, where population-specific calibration can affect diagnostic thresholds.[28] Our comprehensive demographic documentation enables stratified analyses and supports regulatory submissions that require diversity demonstration.

The Future of Biospecimen Quality Standards

Emerging technologies and evolving regulations keep raising quality expectations. Multi-omic integration studies combine transcriptomics, proteomics, metabolomics, and epigenomics. These studies demand unprecedented quality, since artificial variation from poor handling can overwhelm the true biological signal.[29] Advanced therapies like CAR-T need starting materials that meet pharmaceutical-grade specifications with full batch traceability.

Artificial intelligence and machine learning applications raise the stakes on specimen quality even further. Algorithms trained on artifact-contaminated data may learn patterns that reflect technical noise rather than biology.[30] Quality-focused procurement is an essential first step toward making sure AI-driven discoveries reflect genuine biology rather than processing confounders.

The regulatory landscape keeps evolving, with growing emphasis on ethical sourcing, informed consent documentation, and data privacy. Providers who demonstrate proactive compliance put their customers in a strong position for success. Sanguine’s commitment to ethical sourcing, comprehensive consent, and robust data protection keeps research programs compliant with current and anticipated requirements.

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Ethical Sourcing and Regulatory Compliance

All Sanguine biospecimens are collected under IRB-approved protocols with full informed consent from every donor. Our HIPAA-compliant data management systems protect donor privacy while giving researchers access to detailed genomic annotation for their studies. We maintain ISO 9001:2015 and ISO 13485:2016 certifications, reflecting our commitment to quality management across all operations.

Donor compensation follows ethical guidelines set by professional societies, ensuring voluntary participation without coercion. Geographic diversity in our collection network across the United States supports health equity in research. It also gives access to populations often left out of biomedical studies. Every specimen is designated Research Use Only (RUO) with clear documentation of its intended application scope.

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References

1. Ramachandran H, Laux J, Moldovan I, et al. Optimal thawing of cryopreserved peripheral blood mononuclear cells for use in high-throughput human immune monitoring studies. Cells. 2012;1(3):313-324. doi:10.3390/cells1030313
2. Engel P, Boumsell L, Balderas R, et al. CD nomenclature 2015: Human leukocyte differentiation antigen workshops as a driving force in immunology. J Immunol. 2015;195(10):4555-4563. doi:10.4049/jimmunol.1502033
3. Chiu YL, Shan L, Huang H, et al. Sprouty2 regulates HIV replication independent of blocking Ras activation. J Immunol. 2014;192(9):4291-4300. doi:10.4049/jimmunol.1302709
4. Maecker HT, McCoy JP, Nussenblatt R. Standardizing immunophenotyping for the Human Immunology Project. Nat Rev Immunol. 2012;12(3):191-200. doi:10.1038/nri3158
5. Stroncek DF, Fellowes V, Pham C, et al. Counter-flow elutriation of clinical peripheral blood mononuclear cell concentrates for the production of dendritic and T cell therapies. J Transl Med. 2004;2:23. doi:10.1186/1479-5876-2-23
6. Lee JA, Spidlen J, Boyce K, et al. MIFlowCyt: the minimum information about a flow cytometry experiment. Cytometry A. 2008;73(10):926-930. doi:10.1002/cyto.a.20623
7. Simaria AS, Hassan S, Varadaraju H, et al. Allogeneic cell therapy bioprocess economics and optimization: Single-use cell expansion technologies. Biotechnol Bioeng. 2014;111(1):69-83. doi:10.1002/bit.25008
8. Drake SK, Bowen RA, Remaley AT, Hortin GL. Potential interferences from blood collection tubes in mass spectrometric analyses of serum polypeptides. Clin Chem. 2004;50(12):2398-2401. doi:10.1373/clinchem.2004.040303
9. Tuck MK, Chan DW, Chia D, et al. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res. 2009;8(1):113-117. doi:10.1021/pr800545q
10. Betsou F, Lehmann S, Ashton G, et al. Standard preanalytical coding for biospecimens: defining the sample PREanalytical code. Cancer Epidemiol Biomarkers Prev. 2010;19(4):1004-1011. doi:10.1158/1055-9965.EPI-09-1268
11. Lippi G, Salvagno GL, Montagnana M, Lima-Oliveira G, Guidi GC, Favaloro EJ. Quality standards for sample collection in coagulation testing. Semin Thromb Hemost. 2012;38(6):565-575. doi:10.1055/s-0032-1315961
12. Debey-Pascher S, Eggle D, Schultze JL. RNA stabilization of peripheral blood and profiling by bead chip analysis. Methods Mol Biol. 2009;496:175-210. doi:10.1007/978-1-59745-553-4_13
13. Vaught J, Rogers J, Carolin T, Compton C. Biobankonomics: developing a sustainable business model approach for the formation of a human tissue biobank. J Natl Cancer Inst Monogr. 2011;2011(42):24-31. doi:10.1093/jncimonographs/lgr009
14. Hewitt SM, Lewis FA, Cao Y, et al. Tissue handling and specimen preparation in surgical pathology: issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med. 2008;132(12):1929-1935. doi:10.5858/132.12.1929
15. Moore HM, Kelly AB, Jewell SD, et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol. 2011;119(2):92-101. doi:10.1002/cncy.20147
16. Ilicic T, Kim JK, Kolodziejczyk AA, et al. Classification of low quality cells from single-cell RNA-seq data. Genome Biol. 2016;17:29. doi:10.1186/s13059-016-0888-1
17. Bakken TE, Hodge RD, Miller JA, et al. Single-nucleus and single-cell transcriptomes compared in matched cortical cell types. PLoS One. 2018;13(12):e0209648. doi:10.1371/journal.pone.0209648
18. Wolock SL, Lopez R, Klein AM. Scrublet: computational identification of cell doublets in single-cell transcriptomic data. Cell Syst. 2019;8(4):281-291.e9. doi:10.1016/j.cels.2018.11.005
19. Freedman LP, Cockburn IM, Simcoe TS. The economics of reproducibility in preclinical research. PLoS Biol. 2015;13(6):e1002165. doi:10.1371/journal.pbio.1002165
20. Levine BL, Miskin J, Wonnacott K, Keir C. Global manufacturing of CAR T cell therapy. Mol Ther Methods Clin Dev. 2017;4:92-101. doi:10.1016/j.omtm.2016.12.006
21. Freedman LP, Venugopalan G, Wisman R. Reproducibility2020: Progress and priorities. F1000Res. 2017;6:604. doi:10.12688/f1000research.11334.1
22. Henderson GE, Cadigan RJ, Edwards TP, et al. Characterizing biobank organizations in the US: results from a national survey. Genome Med. 2013;5(1):3. doi:10.1186/gm407
23. Bledsoe MJ, Grizzle WE. Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape. Diagn Histopathol. 2013;19(9):322-330. doi:10.1016/j.mpdhp.2013.06.011
24. Berglund S, Magalhaes I, Gaballa A, et al. Advances in umbilical cord blood cell therapy: the present and the future. Expert Opin Biol Ther. 2017;17(6):691-699. doi:10.1080/14712598.2017.1316713
25. Coppola L, Cianflone A, Grimaldi AM, et al. Biobanking in health care: evolution and future directions. J Transl Med. 2019;17(1):172. doi:10.1186/s12967-019-1922-3
26. Vormittag P, Gunn R, Ghorashian S, Veraitch FS. A guide to manufacturing CAR T cell therapies. Curr Opin Biotechnol. 2018;53:164-181. doi:10.1016/j.copbio.2018.01.025
27. Nédélec Y, Sanz J, Baharian G, et al. Genetic ancestry and natural selection drive population differences in immune responses to pathogens. Cell. 2016;167(3):657-669.e21. doi:10.1016/j.cell.2016.09.025
28. Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter JD. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design. J Natl Cancer Inst. 2008;100(20):1432-1438. doi:10.1093/jnci/djn326
29. Hasin Y, Seldin M, Lusis A. Multi-omics approaches to disease. Genome Biol. 2017;18(1):83. doi:10.1186/s13059-017-1215-1
30. Rajkomar A, Dean J, Kohane I. Machine learning in medicine. N Engl J Med. 2019;380(14):1347-1358. doi:10.1056/NEJMra1814259