Abstract | BACKGROUND: Epstein-Barr virus (EBV) DNA detection in the nasopharynx is considered a biomarker for nasopharyngeal carcinoma (NPC). We evaluated its performance as a reflex test to triage EBV seropositives within an NPC screening program in China. METHODS: The study population was embedded within an ongoing NPC screening trial and included 1111 participants who screened positive for anti-EBV VCA ( antibodies against EBV capsid antigens)/EBNA1 (EBV nuclear antigen1)- IgA antibodies (of 18 237 screened). Nasopharynx swabs were collected/tested for EBNA1 gene EBV DNA load. We evaluated performance of EBV DNA in the nasopharynx swab as a reflex test to triage EBV serological high-risk (those referred to endoscopy/MRI) and medium-risk (those referred to accelerated screening) individuals. RESULTS: By the end of 2019, we detected 20 NPC cases from 317 serological high-risk individuals and 4 NPC cases from 794 medium-risk individuals. When used to triage serological high-risk individuals, nasopharynx swab EBV DNA was detected in 19/20 cases (positivity rate among cases: 95.0%; 95% CI, 75.1%-99.9%), with a referral rate of 63.4% (201/317, 95% CI, 57.8%-68.7%) and NPC detection rate among positives of 9.5% (19/201, 95% CI, 5.8%-14.4%). The performance of an algorithm that combined serology with triage of serology high-risk individuals using EBV DNA testing yielded a sensitivity of 72.4% (95% CI, 3.0%-81.4%) and specificity of 97.6% (95% CI, 97.2%-97.9%). When used to triage EBV serological medium-risk individuals, the positivity rate among cases was 75.0% (95% CI, 19.4%-99.4%), with a referral rate of 61.8% (95% CI, 58.4%-65.2%) and NPC detection rate among positives of 0.6% (95% CI, 0.1%-1.8%). CONCLUSIONS: Nasopharynx swab EBV DNA showed promise as a reflex test to triage serology high-risk individuals, reducing referral by ca. 40% with little reduction in sensitivity compared to a serology-only screening program.
|
Authors | Geng Hang Chen, Zhiwei Liu, Kelly J Yu, Anna E Coghill, Xiao Xia Chen, Shang Hang Xie, Dong Feng Lin, Qi Hong Huang, Yu Qiang Lu, Wei Ling, Chu Yang Lin, Zi Jian Lu, Yu Ying Fan, Lin Quan Tang, Joshua N Sampson, Hui Li, Ann D King, Jaap M Middeldorp, Allan Hildesheim, Su Mei Cao |
Journal | Clinical chemistry
(Clin Chem)
Vol. 68
Issue 7
Pg. 953-962
(07 03 2022)
ISSN: 1530-8561 [Electronic] England |
PMID | 35325087
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Research Support, N.I.H., Intramural)
|
Copyright | © American Association for Clinical Chemistry 2022. All rights reserved. For permissions, please email: [email protected]. |
Chemical References |
- Antibodies, Viral
- DNA, Viral
- Immunoglobulin A
- DNA
|
Topics |
- Antibodies, Viral
- DNA
- DNA, Viral
- Epstein-Barr Virus Infections
(diagnosis)
- Herpesvirus 4, Human
(genetics)
- Humans
- Immunoglobulin A
- Nasopharyngeal Carcinoma
(diagnosis)
- Nasopharyngeal Neoplasms
(diagnosis)
- Nasopharynx
- Reflex
- Triage
|