Compliance and Quality Control Pathways for High-Throughput Screening Implementation in Clinical Laboratories

Clinical Application Scenarios and Screening Positioning

High-throughput screening can be used in clinical laboratories for bloodborne pathogen nucleic acid screening, respiratory pathogen panel testing, preliminary screening of autoimmune disease markers, and newborn inherited metabolic disease screening. A common feature of these scenarios is a relatively large number of samples and certain turnaround time requirements, but positive screening results still need to be confirmed through supplementary tests or comprehensive clinical evaluation and cannot be directly used as the basis for a final diagnosis.

Compliance Requirements for In Vitro Diagnostic Reagents and Equipment

In mainland China, in vitro diagnostic reagents and supporting instruments used for clinical screening generally should obtain the corresponding medical device registration or filing certificate. Before introducing a high-throughput screening system, laboratories need to verify whether the product's intended use is consistent with the expected screening items and confirm the equipment installation conditions, calibration cycle, and maintenance plan. Product management requirements differ by risk level, and laboratories should follow current regulations and technical review guidelines.

Performance Verification and Internal Quality Control

Before a new system is put into use, the laboratory should complete performance verification covering precision, accuracy, limit of detection, anti-interference capability, and other items to confirm that it meets the intended use under the laboratory's environment and operator proficiency. Internal quality control generally includes testing quality control materials daily or with each batch and monitoring drift trends through quality control charts. Because high-throughput screening involves a large sample volume, particular attention should be paid to cross-contamination and sample carryover, and negative quality control materials can be interspersed periodically for testing.

Result Reporting and Risk Communication

When reporting high-throughput screening results, laboratories are advised to use neutral expressions such as screening positive and screening negative and to note recommendations for further confirmation. Result interpretation should be performed by qualified professionals in combination with clinical manifestations and other examinations. Indicators related to screening items, such as sensitivity and specificity, may be objectively described in technical documents, but absolute guarantees should not be made in public-facing promotional materials.