International Organization for Standardization (ISO) Accreditation
Agiomix has received the ISO 15189:2012 Accreditation from the Emirates International Accreditation Centre for Next Generation Sequencing clinical assays on January 2021.
With this additional reputable international accreditation, Agiomix now has the unique capacity to offer its healthcare partners and patients, unparalleled clinical diagnostics services in the area of genetics. We are very pleased and honored by this accreditation and we look forward to more international recognition as our services and family grow.
ISO accreditation will add the Lab’s strength and ability to lead the area in clinical genetics applications.
College of American Pathologists (CAP) Accreditation
The College of American Pathologists (CAP) is an internationally recognized leader in laboratory quality assurance and excellence in healthcare. The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses and demonstrate compliance with scientifically approved laboratory operating standards.
CAP-accredited laboratories are required to have a quality management program that validates the quality and safety of laboratory medical services as well as external quality assurance (also called proficiency testing) which establishes laboratory quality and is monitored on a continual basis.
CAP Proficiency Testing
Agiomix is committed to providing high quality, accurate and consistent clinical reporting. As a part of this commitment, Agiomix participates in multiple Proficiency Testing Schemes that ensures that our laboratory is meeting the highest standards of quality.
Proficiency testing is an ongoing, rigorous routine which involves receipt of unknown samples that need to be tested against pre-defined parameters. The results of which are submitted to CAP. This testing allows Agiomix to ensure that our technical competency is maintained and provide information to continuously monitor the laboratory’s performance. It also guarantees that Agiomix is keeping up with the rapidly evolving changes in laboratory medicine and technology.
CAP Proficiency Testing Statistics
| Test Name | Test Code | Analyte | Evaluation Date | Score | % | Cumulative Performance |
|---|---|---|---|---|---|---|
| OncoSeq BRCA | 24104 | BRCA 1/2 Sequencing Analysis | 12/15/2020 | 3/3 | 100 | Successful |
| OncoSeq BRCA | 24104 | BRCA Clinical Interpretation | 12/15/2020 | 3/3 | 100 | Successful |
| OncoSeq BRCA | 24104 | BRCA 1/2 Sequencing Analysis | 3/23/2020 | 3/3 | 100 | Successful |
| OncoSeq BRCA | 24104 | BRCA Clinical Interpretation | 3/23/2020 | 3/3 | 100 | Successful |
| HBV, HCV, HIV Qualitative Detection | 41102 41104 41101 | Viral Identification | 11/16/2020 | 4/4 | 100 | Successful |
| HBV, HCV, HIV Qualitative Detection | 41102 41104 41101 | Viral Identification | 11/21/2020 | 5/5 | 100 | Successful |
| HPV Qualitative Detection | 41106 | Viral Identification | 12/8/2020 | 2/2 | 100 | Successful |
| HCV Quantitative Detection | 41103 | HCV Viral Load | 2/21/2020 | 5/5 | 100 | Successful |
| HCV Quantitative Detection | 41103 | HCV Viral Load | 11/23/2020 | 5/5 | 100 | Successful |
| HCV Qualitative Detection | 41102 | HCV, Qual | 11/23/2020 | 1/1 | 100 | Successful |
| HCV Qualitative Detection | 41102 | HCV, Qual | 2/21/2020 | 1/1 | 100 | Successful |
| HIV Quantitative Detection | 41108 | HIV Viral Load | 3/6/2020 | 5/5 | 100 | Successful |
| HIV Quantitative Detection | 41108 | HIV Viral Load | 11/16/2020 | 5/5 | 100 | Successful |
| HLA-B27 | 43101 | HLA-B27 Antigen Typing | 12/21/2020 | 5/5 | 100 | Successful |
| Factor V, Factor II Mutation Screening | 44102 44103 | FVL Genotype (TPM) | 11/5/2020 | 3/3 | 100 | Successful |
| Factor V, Factor II Mutation Screening | 44103 44103 | FVL Interpretation (TPM) | 11/5/2020 | 3/3 | 100 | Successful |
| Factor II Mutation Screening | 44103 | Factor II Genotype (TPM) | 11/5/2020 | 3/3 | 100 | Successful |
| Factor II Mutation Screening | 44103 | Factor II Interpretation (TPM) | 11/5/2020 | 3/3 | 100 | Successful |
