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China approves two updated national biochip standards

China’s State Administration for Market Regulation has approved two revised voluntary national biochip standards, effective February 1, 2027. The terminology standard replaces the 2011 edition and adds nucleic acid testing chips, immunoassay chips and organ chips. The other standard sets requirements for sample handling, locus validation, performance and reporting in microarray testing for disease-susceptibility DNA polymorphisms.

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What to know

  • 01

    Test loci must be validated in Chinese population studies involving at least 500 people.

  • 02

    Locus detection rates must reach at least 99%, with accuracy and repeatability each at least 99.9%.

Why it matters

The standards are intended to provide a common technical reference for biochip development, quality evaluation and health management services.

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