China

Nanjing Shihe Medical Laboratory Co.,Ltd.

128 Huakang Road, Nanjing, 210000, People's Republic of China, Nanjing, China

A2LA 5427.01ISO 15189Register refreshed 2026-11-06

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Scope lines: 5
A2LA certificate: 1
Site in our directory: 1

A2LA accredited scope

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.

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A2LA certificate 5427.01 · 5 lines

Line	Method	Matrix	Range
1	-	Plasma (P); Sputum (SP); Sterile Swabs (SS); Stool (ST); Urine (U); Whole Blood (WB); Pathology Tissue; Other Bodily Fluids/ Tissues Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 5427.01) 11/07/2024 Page 1 of 4 SCOPE OF ACCREDITATION TO ISO 15189:2022 NANJING SHIHE MEDICAL LABORATORY CO., LTD. 128 Huakang Road, Nanjing, PEOPLE’S REPUBLIC OF CHINA 210032 Ryan S. Robetorye MD, PhD Phone: 400 636 2325 CLINICAL Valid To: December 31, 2026 Certificate Number: 5427.01 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), Sputum (SP), Sterile Swabs (SS), Stool (ST), Urine (U), Whole Blood (WB), Pathology Tissue, and other bodily fluids/tissues: Specialty Sub Specialty Test/ Analytes Method(s) Matrix(ces) Pathology Molecular Pathology ALK Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues BRAF Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues BRCA1/2 Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Copy Number Variant Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues EGFR Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Germline Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues	-
2	Next-Generation Sequencing	Pathology Tissue; Other Bodily Fluids/ Tissues; P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues	-
3	-	P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues; Pathology Tissue Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 5427.01) 11/07/2024 Page 3 of 4 Specialty Sub Specialty Test/ Analytes Method(s) Matrix(ces) Pathology (Cont.) Molecular Pathology Multiple Gene Panel Mutation Detection for Solid Tumor (437 Genes) Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues RB1 Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues RET Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Single Nucleotide Variant Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Somatic Mutation Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Structural Variant Detection Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Tumor Mutational Burden Analysis Next-Generation Sequencing P, SP, SS, ST, U, WB, Pathology Tissue, Other Bodily Fluids/ Tissues Histopathology Immunohistochemistry Staining of Predictive Biomarker. PD-L1, 22C3 Clone Staining, Microscopy Pathology Tissue Immunohistochemistry Staining of Predictive Biomarker. PD-L1, 28-8 Clone Staining, Microscopy Pathology Tissue Routine Processing Manual, Microscopy Pathology Tissue	-
4	-	Pathology Tissue; Pathology Tissue Show page text Extracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 5427.01) 11/07/2024 Page 4 of 4 Specialty Sub Specialty Test/ Analytes Method(s) Matrix(ces) Pathology (Cont.) Histopathology Tissue Type Evaluation- Hematoxylin & Eosin Staining Staining, Microscopy Pathology Tissue Tumor Cell Content Evaluation- Hematoxylin & Eosin Staining Staining, Microscopy Pathology Tissue	-
5	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 SHIHE MEDICAL LABORATORY 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 7th day of November 2024. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 5427.01 Valid to December 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 2026-11-06.

This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the A2LA entry linked above.