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Clinical Diagnostics – NABL Accredited

NABL Accreditation – Medical Testing Laboratory

ISO 15189:2022

AMMAGENOMICS Molecular Testing Laboratory is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), India, in accordance with ISO 15189:2022 – Medical Laboratories: Requirements for Quality and Competence, for specific medical testing parameters as defined in the approved Scope of Accreditation.

This accreditation confirms the laboratory’s technical competence, quality management system, and compliance with internationally accepted medical laboratory standards, only for the tests listed in the NABL-approved scope.

Scope of NABL Accreditation – Medical Testing

AMMAGENOMICS Molecular Testing Laboratory is accredited for a defined scope of medical testing parameters, including clinical biochemistry and molecular diagnostics, as officially approved by NABL.

Broad Categories Covered Under the Accredited Scope :

Molecular Diagnostics (Accredited Matrices) Sample Types Include (as per scope):

Amniotic fluid, ascitic fluid, blood, CSF, saliva, stool, urine, sputum, semen, swabs (NP/OP), tissue-associated samples, and other approved biological matrices.

Accredited Molecular Tests Include:

  • Cell-free DNA (cfDNA) cancer marker profiling
  • Cell-free DNA mitochondrial quantification (% cf-mtDNA)
  • Cell-free DNA nuclear quantification (% cf-nDNA)
  • Cell-free RNA cancer marker profiling
  • Cell-free RNA inflammatory marker profiling
  • Cell-free RNA mitochondrial marker profiling
  • Microbiome profiling (relative abundance / copies per mL, as applicable)
  • SARS-CoV-2 RNA (Qualitative)
  • HIV-1 RNA (Qualitative and Quantitative)
  • HCV RNA (Qualitative)

Clinical Biochemistry (Accredited Matrices)

  • Blood
  • Plasma
  • Semen
  • Saliva
  • Urine

Accredited Parameters Include:

  • Total Polyphenols (Gallic Acid Equivalent)
  • Total Antioxidant Capacity (ABTS, DPPH, FRAP)
  • Anthocyanins
  • Curcumin
  • Ellagic Acid
  • Hesperidin
  • Quercetin
  • Resveratrol
  • Rutin
  • Ubiquinone
  • Oxidative stress marker: MDA (TBA method)

(Methods primarily based on validated spectrophotometric techniques as per approved SOPs.)

What ISO 15189:2022 NABL Accreditation Means

NABL accreditation under ISO 15189:2022 demonstrates that:

  • Medical testing is performed using validated and documented methods
  • Personnel are qualified, trained, and competency-assessed
  • Equipment, reagents, and infrastructure meet medical laboratory quality requirements
  • Pre-analytical, analytical, and post-analytical processes are controlled
  • Test results are generated with traceability, quality control, and technical integrity
  • Accredited test reports are internationally acceptable under the ILAC-MRA framework,
    only for parameters included in the approved scope

Important:
ISO 15189:2022 accreditation applies only to the tests and sample types listed in the Scope of Accreditation. It does not imply blanket accreditation of all laboratory activities or services.

(Performed using Real-Time qPCR / RT-qPCR techniques as approved under the NABL scope.)

Important Regulatory Disclosures

Mandatory Disclaimer

  • NABL ISO 15189:2022 accreditation does not imply clinical diagnosis, treatment recommendation, or medical advice
  • Individual laboratory parameters must be interpreted in appropriate clinical context
  • Test results are intended to support clinical correlation by qualified healthcare professionals

AMMAGENOMICS may offer additional scientifically valid tests outside the NABL scope;
such tests are clearly identified as non-accredited

International Recognition (ILAC-MRA)
NABL is a signatory to the International Laboratory Accreditation Cooperation – Mutual Recognition Arrangement (ILAC-MRA).

This means:

  • Accredited medical test results are technically accepted internationally
  • Acceptance applies only to parameters covered under the approved NABL scope
  • Subject of importing country regulations, clinical policies, and statutory requirements

Verification of Accreditation
Accreditation status and scope details can be independently verified on the official NABL website:
www.nabl-india.org

Accreditation Overview

  • Laboratory Name:AMMAGENOMICS Molecular Testing Laboratory
  • Legal Entity:AMMAGENOMICS LLP
  • Certificate Number:MC-7933
  • Accreditation Standard:ISO 15189:2022
  • Field:Medical Testing
  • Validity Period:05 February 2026 to 04 February 2030
  • Laboratory Location:
    AMMAGENOMICS Molecular Testing Laboratory
    87, Arcot Road, Saligramam,
    Chennai – 600093, Tamil Nadu, India
  • Accreditation Body:National Accreditation Board for Testing and Calibration Laboratories (NABL), India
  • International Recognition:ILAC-MRA Signatory
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