VAMS LABS™ · quality & validation

Quality controls and validation boundaries, shown clearly.

Credible microbiome work depends on honest quality practice — and on being clear about what “validation” does and does not mean. This page describes how the pipeline is checked and where its limits lie.

Ask About Validation See the Sample Workflow

Sample integrity checksExtraction & run QCBatch / contamination awareDocumented workflowMethod-bounded interpretationResearch-use framing

Validation philosophy

Method validation vs clinical validation — kept distinct

Method/workflow validation means a workflow reliably does what it is designed to do for research-use outputs. Clinical validation is a separate, regulated process establishing performance for medical decision-making. Unless a specific clinical pathway is verified and formally approved, VAMS LABS™ describes the former, not the latter.

✓Method/workflow validation — consistency and reproducibility of research-use outputs.
✓Clinical validation — a distinct, separately governed and regulated process.
✓Outputs are educational and non-diagnostic unless a separately approved pathway exists.

Reproducibility

How reproducibility is approached

Analytical reproducibility is assessed using replicate quality monitoring and laboratory quality-assurance procedures. Quantitative figures are established during laboratory validation and are not stated speculatively.

Replicate quality monitoring across runs and batches

Versioned pipelines keep analyses comparable over time

Laboratory quality-assurance procedures applied throughout

Batch and contamination effects considered in design and analysis

Sequencing quality & coverage

Depth, coverage and quality filters

Sequencing depth	Minimum sequencing depth is established according to the validated laboratory protocol.
Coverage	Coverage is matched to the method and research question; greater depth is not automatically more informative.
Quality filters	Raw-data QC and bioinformatics quality filters are applied before any output is generated.
Reproducible pipelines	Versioned, documented pipelines so results remain comparable across runs and cohorts.

Controls & quality assurance

How quality is handled — and made visible

Sample integrity & intake checks — samples are logged and reviewed at intake; integrity concerns are flagged before processing.

Extraction QC framing — extraction is assessed for quality and quantity appropriate to the chosen method.

Run-level QC — sequencing runs carry quality checks; low-quality data is identified rather than hidden.

Controls where verified — positive/negative controls are used where verified for the workflow and project scope.

Batch & contamination awareness — batch effects and contamination are considered in design and analysis, not ignored.

Re-run / review triggers — defined triggers prompt re-runs or review without exposing internal thresholds.

Documentation & audit trail — project intake, methods and versions are documented for reproducibility.

Clear limitation statements — every output states what it can and cannot support.

Detection limitations

What detection depends on

Detection capability depends on sample type, sequencing chemistry and assay configuration. Quantitative limits of detection are established during laboratory validation and are assay- and laboratory-specific — they are not stated as fixed figures until verified.

✓Detection is influenced by sample type and preservation
✓Sequencing chemistry and depth affect what can be resolved
✓Quantitative limits are established during laboratory validation

Reference cohorts

The curated reference behind interpretation

Interpretation is contextualised against a curated reference of public datasets. These figures are traceable to the Phase 1 cohorts & datasets workbook.

Curated datasets	106 datasets across 58 curated cohorts
Expected reference samples	Approximately 23,000 (sum of dataset expected counts)
Body-site systems	5 — gut, vaginal, oral, skin and multi-system
Sequencing methods	16S amplicon (79 datasets) and shotgun metagenomics (21 datasets)
Curation quality	Mean admissibility score 4.4 / 5 across curated datasets

Reference-cohort details are described in full on the Reference Cohorts page (/science/reference-cohorts).

Partner laboratory attribution

Processing & sequencing partners

VAMS BioInnovation Private Limited coordinates sample processing and sequencing with qualified partners. VAMS is not itself an accredited laboratory; accreditation, quality certification and permitted testing scope vary by partner and are verified directly with each partner.

Partner laboratory	Country	Role	Accreditation	Status
BMKGENE (Biomarker Technologies)	China	16S amplicon & NGS sequencing	Verified directly with partner	Active partner
Zymo Research	United States	Extraction kits & sequencing services	Verified directly with partner	Active partner
Norgen Biotek	Canada	Sample collection & extraction	Verified directly with partner	Active partner

Accreditation numbers are available on request and can be verified directly with each partner. Listing a partner does not imply that VAMS BioInnovation Private Limited holds that accreditation.

Method limitations

What this validation does not cover

Not clinical validation unless separately verified and approved Not a diagnosis, screening or treatment tool No fixed quantitative performance figures stated before verification No accreditation claimed for VAMS itself Results are method-bounded and research-use

Questions about quality or validation?

Tell us about your project and we will explain the QC practices and validation boundaries that apply to your scope.

Ask About Validation See the Sample Workflow