scholarly journals Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)

2020 ◽  
Vol 10 (3) ◽  
pp. 178-185
Author(s):  
Anja Dörschug ◽  
Julian Schwanbeck ◽  
Andreas Hahn ◽  
Anke Hillebrecht ◽  
Sabine Blaschke ◽  
...  

AbstractIntroductionTo efficiently monitor the COVID-19 pandemic for surveillance purposes, reliable serological rapid diagnostic tests (RDTs) are desirable for settings where well-established high-throughput bench-top solutions are not available. Here, we have evaluated such an RDT.MethodsWe have assessed the Xiamen AmonMed Biotechnology COVID-19 IgM/IgG test kit (Colloidal gold) and the EUROIMMUN benchtop assay with serum samples from patients with polymerase chain reaction (PCR)-confirmed COVID-19 disease. Samples from patients with Epstein-Barr-virus (EBV) infection and blood donors were used for specificity testing.ResultsFor the colloid gold rapid test and the EUROIMMUN assay, the study indicated overall sensitivity of 15.2% and 67.4%, respectively, while specificity of 99.0% and 97.9% with the blood donor sera, as well as 100% and 96.8% with the EBV-patients, were observed, respectively. An association of the time period between positive PCR results and serum acquisition with serological test positivity could be observed for the immunologlobulin G subclass of the EUROIMMUN assay only.ConclusionsIn spite of acceptable specificity of the assessed RDT, the detected poor sensitivity leaves room for improvement. The test results remain difficult to interpret and therefore the RDT can currently not be recommended for routine diagnostic or surveillance use.

2020 ◽  
Vol 25 (12) ◽  
Author(s):  
Bo Albinsson ◽  
Anu E. Jääskeläinen ◽  
Kairi Värv ◽  
Mateja Jelovšek ◽  
Corine GeurtsvanKessel ◽  
...  

Background Tick-borne encephalitis (TBE) is a potentially severe neurological disease caused by TBE virus (TBEV). In Europe and Asia, TBEV infection has become a growing public health concern and requires fast and specific detection. Aim In this observational study, we evaluated a rapid TBE IgM test, ReaScan TBE, for usage in a clinical laboratory setting. Methods Patient sera found negative or positive for TBEV by serological and/or molecular methods in diagnostic laboratories of five European countries endemic for TBEV (Estonia, Finland, Slovenia, the Netherlands and Sweden) were used to assess the sensitivity and specificity of the test. The patients’ diagnoses were based on other commercial or quality assured in-house assays, i.e. each laboratory’s conventional routine methods. For specificity analysis, serum samples from patients with infections known to cause problems in serology were employed. These samples tested positive for e.g. Epstein–Barr virus, cytomegalovirus and Anaplasma phagocytophilum, or for flaviviruses other than TBEV, i.e. dengue, Japanese encephalitis, West Nile and Zika viruses. Samples from individuals vaccinated against flaviviruses other than TBEV were also included. Altogether, 172 serum samples from patients with acute TBE and 306 TBE IgM negative samples were analysed. Results Compared with each laboratory’s conventional methods, the tested assay had similar sensitivity and specificity (99.4% and 97.7%, respectively). Samples containing potentially interfering antibodies did not cause specificity problems. Conclusion Regarding diagnosis of acute TBEV infections, ReaScan TBE offers rapid and convenient complementary IgM detection. If used as a stand-alone, it can provide preliminary results in a laboratory or point of care setting.


Author(s):  
Jacob A Miller ◽  
Quynh-Thu Le ◽  
Benjamin A Pinsky ◽  
Hannah Wang

Abstract Background The incidence of endemic Epstein-Barr Virus (EBV)-associated nasopharyngeal carcinoma (NPC) varies considerably worldwide. In high-incidence regions, screening trials have been conducted. We estimated the mortality reduction and cost-effectiveness of EBV-based NPC screening in populations worldwide. Methods We identified 380 populations in 132 countries with incident NPC and developed a decision-analytic model to compare ten unique onetime screening strategies to no screening for men and women at age 50 years. Screening performance and the stage distribution of undiagnosed NPC were derived from a systematic review of prospective screening trials. Results Screening was cost-effective in up to 14.5% of populations, depending on the screening strategy. These populations were limited to East Asia, Southeast Asia, North Africa, or were Asian, Pacific Islander, or Inuit populations in North America. A combination of serology and nasopharyngeal polymerase chain reaction (PCR) was most cost-effective, but other combinations of serologic and/or plasma PCR screening were also cost-effective. The estimated reduction in NPC mortality was similar across screening strategies. For a hypothetical cohort of patients in China, 10-year survival improved from 71.0% (95%CI = 68.8%–73.0%) without screening to a median of 86.3% (range = 83.5%–88.2%) with screening. This corresponded to a median 10-year reduction in NPC mortality of 52.9% (range= 43.1%–59.3%). Screening interval impacted absolute mortality reduction and cost-effectiveness. Conclusions We observed decreased NPC mortality with EBV-based screening. Screening was cost-effective in many high-incidence populations and could be extended to men and women as early as age 40 years in select regions. These findings may be useful when choosing among local public health initiatives.


2021 ◽  
Vol 31 (1) ◽  
Author(s):  
Xiaoguang Li ◽  
Jing Chen ◽  
Fei Lin ◽  
Wei Wang ◽  
Jie Xu ◽  
...  

AbstractRapid influenza diagnosis can facilitate targeted treatment and reduce antibiotic misuse. However, diagnosis efficacy remains unclear. This study examined the efficacy of a colloidal gold rapid test for rapid influenza diagnosis. Clinical characteristics of 520 patients with influenza-like illness presenting at a fever outpatient clinic during two influenza seasons (2017–2018; 2018–2019) were evaluated. The clinical manifestations and results of routine blood, colloidal gold, and nucleic acid tests were used to construct a decision tree with three layers, nine nodes, and five terminal nodes. The combined positive predictive value of a positive colloidal gold test result and monocyte level within 10.95–12.55% was 88.2%. The combined negative predictive value of a negative colloidal gold test result and white blood cell count > 9.075 × 109/L was 84.9%. The decision-tree model showed the satisfactory accuracy of an early influenza diagnosis based on colloidal gold and routine blood test results.


2018 ◽  
Vol 8 (3) ◽  
pp. 198-206
Author(s):  
Keita Nakanishi ◽  
Hiroshi Kaito ◽  
Miki Ogi ◽  
Denshi Takai ◽  
Junya Fujimura ◽  
...  

Viral infections in patients with post-kidney transplantation are often difficult to diagnose as well as treat. We herein report three cases with severe viral infections after kidney transplantation. All their causative pathogens could be detected promptly by polymerase chain reaction and flow cytometry during the early stages of infection. These examinations would also be of great use to monitor therapeutic responses and disease activity. It is indeed true that no specific treatment is available for most of the viral infections, but we should be aware that some infections, such as Epstein-Barr virus infection, can be treatable with prompt and specific treatment, such as rituximab.


2012 ◽  
Vol 43 (1) ◽  
pp. 393-404 ◽  
Author(s):  
Marcos Antonio Pereira de Lima ◽  
Márcia Valéria Pitombeira Ferreira ◽  
Marcos Aurélio Pessoa Barros ◽  
Maria Inês de Moura Campos Pardini ◽  
Adriana Camargo Ferrasi ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document