YY/T 0589-2016 in English

Core changes in the standard revision

Analysis of key technical requirements

1. Electrode performance indicators

The slope of the ion selective electrode should meet the following requirements: K+(40-70mV), Na+(40-70mV), iCa2+(20-40mV). The newly added Li+ detection must meet the following requirements:

• Accuracy: ±5% or ±0.05mmol/L
• Linear range: 0.4-2.0mmol/L

2. Precision control

Use No. 3 quality control solution for 10 consecutive tests. CV requirements:

Implementation suggestions

1. Quality control solution management

When preparing the 5-point fixed-value quality control solution according to Appendix A, please note:

• Anhydrous reagents need to be dried at 105℃ for 2 hours
• MOPS buffer system needs to be dried at 80℃
• Store away from light for ≤3 months after preparation

2. Key points of equipment verification

1. Linearity verification requires testing of quality control solutions No. 1-5
2. Carryover contamination rate assessment uses alternating testing of No. 1/5
3. The new version of the stability test requires monitoring across 8 hours

Background of standard evolution

As the importance of electrolyte testing in the diagnosis and treatment of acute and critical illnesses increases, the 2016 version of the standard:

• Response to clinical testing needs for Li+ (psychiatric drug monitoring) and iCa2+ (intraoperative monitoring)
• Strengthen analytical methodology requirements and introduce correlation coefficients to evaluate linearity
• Optimize stability test schemes to be more in line with actual usage scenarios