Nanjing Simcere Medical Laboratory Science Co.,
Building #5,699-18 Xuanwu Avenue, Xuanwu District, Nanjing, 210023, People's Republic of China, Nanjing, China
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What this lab is accredited for
We could not match the method references in this lab’s scope to published test standard numbers. The full scope as published is below.
Only this lab. Searches the method, matrix and range of each of the 3 scope lines.
A2LA certificate 6529.01 · 3 lines
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | - | Plasma (P); Formalin Fixed Paraffin Embedded (FFPE) Tissue; Other Bodily Fluids/Tissue; FFPE; P; WBShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 6529.01) Revised 04/15/2025 Page 1 of 2
SCOPE OF ACCREDITATION TO ISO 15189:2022
NANJING SIMCERE MEDICAL LABORATORY
SCIENCE CO., LTD.
Building #5, 699-18 Xuanwu Avenue,
Xuanwu District,
Nanjing, PEOPLE’S REPUBLIC OF CHINA 210023
Dr. Qiang Gong Phone: 86-13975806193
CLINICAL
Valid To: May 31, 2026 Certificate Number: 6529.01
In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform
the following types of testing on human samples, including Plasma (P), Formalin Fixed Paraffin Embedded (FFPE) Tissue,
and Other Bodily Fluids/Tissue:
Specialty Sub
Specialty
Test/Analyte Method Matrix
Pathology
Histopathology
Tissue Type Evaluation-
Hematoxylin & Eosin
Staining
Staining, Microscopy FFPE
Tumor Cell Content
Evaluation- Hematoxylin &
Eosin Staining
Staining, Microscopy FFPE
Molecular Pathology
Copy Number Variant
Detection
Next-Generation
Sequencing
FFPE, P, Other
Bodily
Fluids/Tissue
Germline Mutation
Detection
Next-Generation
Sequencing
FFPE, P, WB,
Other Bodily
Fluids/Tissue
Insertion/Deletion (<50bp)
Variant Detection
Next-Generation
Sequencing
FFPE, P, Other
Bodily Fluids/Tissue
Microsatellite Instability (MSI) Next-Generation Sequencing FFPE, P, Other Bodily
Fluids/Tissue
Multiple Gene Panel
Mutation Detection for Cell-
Free DNA (158 Genes)
Next-Generation
Sequencing
P
Multiple Gene Panel
Mutation Detection for Solid
Tumor (566 Genes)
Next-Generation
Sequencing
FFPE, P, Other
Bodily
Fluids/Tissue | - |
| 2 | Next-Generation Sequencing | FFPE, P, Other Bodily Fluids/Tissue; FFPE, P, Other Bodily Fluids/Tissue; FFPE, P, Other Bodily Fluids/Tissue | - |
| 3 | Extracted from the scope document; tables may not line up. View scope for the original. For the tests to which this accreditation applies, please refer to the laboratory’s Clinical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
NANJING SIMCERE MEDICAL
LABORATORY SCIENCE CO., LTD.
Nanjing, PEOPLE’S REPUBLIC OF CHINA
for technical competence in the field of
Clinical
This laboratory is accredited in accordance with the recognized International
Standard ISO 15189:2022 Medical laboratories – Requirements for quality and competence. This
accreditation demonstrates technical competence for a defined scope and the operation of a laboratory
quality management system (refer to joint IAF-ILAC-ISO Communiqué dated November 2021).
Presented this 11th day of June 2024.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 6529.01
Valid to May 31 , 2026 | ||
Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
Accreditation data refreshed from the A2LA register on .
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