GB/T 37868-2019 in English

VALID

Technical specifiction for traceability of nucleic acid test kit

Issued on:2019-08-30
Implemented on:2019-08-30
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	GB/T 37868-2019
Document status:	VALID
Title in English:	Technical specifiction for traceability of nucleic acid test kit
Title in Chinese:	核酸检测试剂盒溯源性技术规范
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2019-08-30
Implemented on:	2019-08-30
Professional Classification:	GB-National Standard
Related Keywords:	nucleic acid test kit introduction primer sequence traceability use genbank nucleic acid detection technology traceability requirements technical specifiction
Related Topics:	Detection kit Detection Reagent Trace the source Detection kit volume of reagent Nucleic acid amplification testing u6 kit Kidney function test kit v6 kit q5 kit Automatic Nucleic Acid Detection Technology Automatic Nucleic Acid Detection Traceability Instant Kit Kit Consumables Nucleic acid detection kit Nucleic acid detection box nucleic acid agent Test box specification Gold kit reagents Nucleic acid detection product technology Molecular detection Nucleic acid detection Test box specification Molecular nucleic acid detection Uric acid kit egfr detection kit kit reagent membrane kit Nucleic acid detection kit nucleic acid amphiphile Nucleic Acid Analysis Technology Micro nucleic acid detection Shihe Kit Shihe, kit Standard Box Reagent Nucleic acid detection window period Pulse element kit About nucleic acid testing abroad Micro nucleic acid detection sex technology Nucleic acid detection window period Nucleic acid detection pcr kit How to detect nucleic acid egfr kit Forensic Test Kit Benzene test kit Nucleic acid detection pcr kit t4 kit Nucleic acid system Lithium Detection Kit Lithium Detection Kit q7 kit pcr nucleic acid technology GBT37868 Ki67 detection kit Detection method of brucellosis detection kit atp detection kit Covid test kit results HIV testing kit sales Kit S/N NanoTemPer his kit Abscisic acid elisa detection kit Phase nuclear device detection specification requirements Test kit testing standards disclosed Testing kit Acid resistance test Nucleic acid detector industry Test kit industry Test kit group Neutron source technology detection

《GB/T 37868-2019核酸检测试剂盒溯源性技术规范》由424-nrccrm（国家标准物质研究中心）归口，主管部门为国家市场监督管理总局。

Introduction

1. Background and importance of standard formulation

Nucleic acid detection kits play a key role in disease diagnosis and precision medicine. To ensure the accuracy and reliability of the kits, GB/T 37868-2019 specifies the traceability requirements for the nominal characteristic values and quantity values of the reagent components.

2. Traceability technical requirements

Reagent components	Nominal characteristic values	Quantity values
Primers, probes	Sequence, including base-specific arrangement order and number	Mass value, molecular weight
Positive quality control	Target gene sequence or component	Concentration value

3. Analysis of technological evolution

From early PCR technology to today's high-throughput sequencing, nucleic acid detection technology has continued to advance. The formulation of GB/T 37868-2019 reflects the industry's higher requirements for accuracy and reliability.

4. Implementation recommendations

Case study: Primer sequence traceability

Use GenBank standard sequence as a reference, combined with sequencing result files and instrument calibration certificates, to ensure sequence accuracy and traceability.

More samples: GB 18306-2015 DL/T 5154-2012 JGJ 94-2008

Sample only — not a preview of GB/T 37868-2019

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