Abstract
What is already known about this topic? Proficiency testing (PT) is a key component of quality assurance and is essential in ensuring accurate laboratory diagnosis of tuberculosis (TB) and drug-resistant TB. The National Tuberculosis Reference Laboratory (NTRL) developed a novel PT panel to test laboratories’ proficiency for molecular TB diagnostic assays throughout the TB laboratory network. A total of 6 PT rounds for molecular diagnostics were conducted by NTRL from 2014 to 2019. What is added by this report? PT conducted using artificial sputum specimens increased from 120 in the first round to 1,835 in the sixth round. Overall, laboratories demonstrated good proficiency for MTB and drug-resistance detection by molecular diagnostics, which is evident from the qualification rates over the six rounds: 95%, 97%, 96%, 93%, 93%, and 97%, respectively. What are the implications for public health practice? The use of artificial sputum specimens for PT panel production to test TB molecular diagnostics in China is feasible. Most of the participating laboratories provided reliable molecular diagnostic results for MTB and drug-resistance detection. The TB laboratory network can be instrumental in implementing PT expansion and improving the quality of TB molecular diagnosis in China.
Highlights
A total of 1,971 sets of Proficiency testing (PT) panels were tested by a variety of molecular diagnostic platforms in the sixth round PT plan, and the qualification rate was 96.3% (1,899/1,971)
All the provincial labs carried out Xpert MTB/RIF testing in the six round PT, three isothermal amplification diagnostics were covered in a total of 20 provincial-level administrative divisions (PLADs)
This study identified that participation rates in PT plans were relatively low at first, which was likely due to not all laboratories performing molecular diagnostics routinely and the National Tuberculosis Reference Laboratory (NTRL) just carrying out PT for Global Fund project sites that had already been equipped with GenoType MTBDR and GeneXpert equipment
Summary
National Proficiency Testing of Molecular Diagnostics for Tuberculosis and Drug Resistance Detection — China, 2014–2019. The National Tuberculosis Reference Laboratory (NTRL) developed a novel PT panel to test laboratories’ proficiency for molecular TB diagnostic assays throughout the TB laboratory network. The use of artificial sputum specimens for PT panel production to test TB molecular diagnostics in China is feasible. NTRL leads the provincial-level TB reference laboratory (PTRL) plan and oversees the services provided by prefectural and county-level TB labs to ensure quality and compliance with biosafety regulations. PT for TB molecular diagnostics was first launched in 2014, and as of 2019, six rounds have been completed This was the first study in China that systematically assessed the procedures and results of the nationwide proficiency testing of molecular diagnostic tools. All PT panels were transported from the NTRL to targeted provincial TB reference laboratories (PTRL), and each of these
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