External Quality Assessment for Rubella Virus RNA Detection Using Armored RNA in China.
BACKGROUND
Although tremendous efforts have been made to reduce rubella incidence, there are still 300 new cases of congenital rubella syndrome daily; thus, rubella infections remain one of the leading causes of preventable congenital birth defects. An effective surveillance system, which could be achieved and maintained by using an external quality assessment program, is critical for prevention and control of this disease.


METHODS
Armored RNAs, which are noninfectious and RNase-resistant, were used for encapsulation of the E1 gene of rubella virus and for preparation of a 10-specimen panel for external quality assessment. Thirty-two laboratories across mainland China that used nucleic acid tests for rubella virus RNA detection were included in the external quality assessment program organized by the National Center for Clinical Laboratories of China.


RESULTS
Different kinds of commercial kits were used by the laboratories for nucleic acid extraction and TaqMan real-time reverse-transcription PCR for rubella virus RNA detection; 99.2% sensitivity and 100% specificity were achieved in this external quality assessment program.


CONCLUSIONS
Most of the participating laboratories obtained accurate results for rubella nucleic acid tests, thereby achieving the quality required for regional rubella and congenital rubella syndrome elimination.
D
D
Zhang
G
G
Lin
L
L
Yi
M
M
Hao
G
G
Fan
X
X
Yang
R
R
Peng
J
J
Ding
K
K
Zhang
R
R
Zhang
J
J
Li
D002681:China; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000592:standards*; D015588:Observer Variation; D011237:Predictive Value of Tests; D019984:Quality Indicators, Health Care / Q000592:standards*; D012367:RNA, Viral / Q000235:genetics*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D060888:Real-Time Polymerase Chain Reaction / Q000592:standards*; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000592:standards*; D012409:Rubella / Q000175:diagnosis* / Q000821:virology; D012412:Rubella virus / Q000235:genetics*
D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic