Comparison of four rapid diagnostic kits using immunochromatography to detect influenza B viruses

We compared the usefulness of 4 rapid influenza diagnostic 1-device kits using immunochromatography, which facilitate type differentiation, i.e. ESPLINE Influenza A&B-N (Fujirebio Corp., Japan: ESPLINE), POCTEM INFLUENZA A/B (Sysmex Corp., Japan: POCTEM), Quick Vue Rapid SP influ (Quidel Corp., U.S.A.: Quick Vue), and Capilia Flu A + B (TAUNS Corp., Japan: Capilia), in 278 children in whom influenza infection was suspected in 2004 and 2005. Nasopharyngeal aspirates were diluted for virus isolation and residual samples were centrifuged. Using the supernatant, we conducted rapid diagnosis testing. Influenza virus AH3 was isolated from 40 children, and influenza B virus from 163. Of the 40 children, the sensitivity and specificity of ESPLINE, POCTEM, Quick Vue, and Capilia were 100%/100%, 95%/100%, 98%/96%, and 98%/96%. In the 163 children, the sensitivity and specificity were 89%/100%, 87%/100%, 88%/97%, and 86%/98%. ESPLINE showed the highest sensitivity and specificity to influenza viruses AH3 and B. All kits were less sensitive to influenza B virus than to influenza A virus, however. The specificity of Quick Vue and Capilia was low; so these kits must be improved.     

Evaluation of immunochromatography method for rapid detection of influenza A and B viruses

We have evaluated a new rapid detection kit for influenza A and B viruses, known as the QuickVue Influenza test (Quidel Coporation, USA); which is based on immunochromatography using virus isolates and clinical specimens. Twelve strains of influenza A and B were tested for evaluate the reactivity and detection limits of this test. The QuickVue Influenza test showed a positive result for all twelve strains of influenza virus and a negative result for fourteen different kinds of other respiratory viruses. The detection limits for six strains were 5 to 30 pfu/ml for a cell culture, 1.0 x 10(3) to 6.0 x 10(4) pfu/ml for 1st PCR, 1 to 50 pfu/ml for nested PCR, 3.0 x 10(5) to 6.0 x 10(5) pfu/ml for the QuickVue Influenza test, 1.5 x 10(5) to 1.0 x 10(6) pfu/ml for the Directigen Flu A, and 7.5 x 10(5) to 5.0 x 10(6) pfu/ml for the FLU OIA. Furthermore, the QuickVue Influenza test were clinically evaluated using 92 throat swab specimens collected from patients with influenza-like illnesses. By cell culture, influenza viruses were detected in 49 of the 92 specimens (AH1N1: 20, AH3N2: 7, B: 22); the titers of the influenza viruses were between 2.5 pfu/ml and 7.0 x 10(5) pfu/ml. Compared to cell culture, the QuickVue Influenza test showed a sensitivity of 75.5%, a specificity of 93.0%, a positive predictive value of 92.5%, a negative predictive value of 76.9%, and an efficiency value of 83.7%. On the other hand, influenza viruses were detected in 54 of the 92 specimens (AH1N1: 19, AH 3N2: 10, B: 25) by RT-PCR. Compared to RT-PCR, the QuickVue Influenza test showed a sensitivity of 72.2%, a specificity of 97.4%, a positive predictive value of 97.5%, a negative predictive value of 71.2%, and an efficiency value of 82.6%. Overall, only one throat swab specimen produced a false positive result using the QuickVue Influenza test; thus, this test appears to have a high specificity. We conclude that the QuickVue Influenza test is a simple one-step test with a sensitivity and specificity equivalent to those of other conventional diagnostic kits. The test is useful and suitable for the diagnosis of influenza and for identifying influenza patients requiring antiviral therapy.     

Evaluation of an immunochromatography test using enzyme immunoassay for rapid detection of influenza A and B viruses

We evaluated the performance of an improved version of Espline Influenza A & B-N (Fujirebio Inc., Japan), an immunochromatography test using enzyme immunoassay for rapid diagnosis of influenza A and B. The test produced positive results for four strains of influenza viruses and thirty-one influenza viral antigens and negative results for all of thirty strains of other respiratory viruses that were tested. The detection limit of this test was 5.8 x 10(2) to 5.8 x 10(3) pfu/assay, which is more sensitive than the old version of Espline. Furthermore, 715 respiratory specimens collected from the patients (children, 79.4%; adults, 18.5%; unknown, 2.1%) with influenza-like illnesses during the 2002/2003 influenza season in Japan were tested as part of a clinical evaluation of this test. The relative performance of this test compared to cell culture and nested RT-PCR results were examined. In the cell cultures, influenza viruses were detected in 488 of the 715 specimens (overall, 68.3%; AH3, 41.7%; B, 26.4%; AH3 and B, 0.1%). For influenza A, the sensitivity of this test was 95.4% (125/131) for nasal aspirates, 96.8% (92/95) for nasal swabs, and 85.1% (63/74) for throat swabs. For influenza B, the sensitivity of this test was 91.2% (52/57) for nasal aspirates, 88.1% (59/67) for nasal swabs, and 71.6% (48/67) for throat swabs. The new test exhibited a remarkably higher sensitivity to influenza A in throat swabs than the old version of Espline. Only two false positive results were obtained out of a total of 223 virus negative specimens; the specificity of the test was 100% (88/88) for nasal aspirates, 97.6% (81/83) for nasal swabs, and 100% (52/52) for throat swabs. We conclude that the new Espline Influenza A&B-N rapid diagnostic test is easy to use and has a high sensitivity and specificity, especially for influenza A.     

Evaluation of immunochromatography test for rapid detection of influenza A and B viruses using real-time PCR

The sensitivity of rapid diagnostic kits to influenza B is lower than to influenza A. The cause-poor performance of the kit or the scarcity of viruses in type B specimens-has yet to be clarified. Using real-time PCR, we measured the amount of influenza viruses with nasopharyngeal aspirate fluid previously identified by virus isolation culture and passing the rapid diagnosis test by four types of kits, including the ESPLINE Influenza A&B-N (Fujirebio Corp., Japan). We classified the results of virus isolation and rapid diagnosis tests into three groups and examined them: group 1 (12 specimens, influenza B, all negative in tests using four types of kits); group 2 (57 specimens, influenza B, all positive in tests); and group 3 (36 specimens, AH3, all positive in tests). The average amount of viruses in group 1 (6.60 +/- 0.81 log10copies/mL) was significantly lower (p<0.0001) than that in group 2 (8.51 +/- 0.57 log10copies/mL) or group 3 (8.72 +/- 0.63 log10copies/mL). No significant difference was seen in the amount of viruses between groups 2 and 3. We concluded that the cause of low sensitivity in rapid diagnostic kits to influenza B are attributable to the scarcity of viruses in the specimen.     

Clinical evaluation of rapid diagnostic kit detecting separately influenza A and B viruses

The Directigen Flu A + B kit, a rapid diagnostic device for influenza virus A and B was evaluated. The nasopharyngeal aspirates were obtained from 239 patients who visited our hospital, between January and March, 2000, presenting flu-like symptoms. Influenza virus AH1: 77 and AH3: 51 were isolated from 128 specimens and none from 111 specimens. Directigen Flu A + B showed 115 specimens positive and 106 specimens negative. The sensitivity and specificity of this kit were 89.8% (115/128) and 95.5% (106/111) compared with viral isolation. Agreement on positive and negative interpretations between Direction Flu A and this kit was 97.9% (234/239). In the evaluation of this kit for influenza B virus, 60 frozen nasopharyngeal aspirates collected from February to April, 1999 were used. The sensitivity and specificity of this kit were 88.9% (16/18) and 88.1% (37/42) compared with viral isolation. Agreement on positive and negative interpretations between FLU OIA and this kit was 91.7% (55/60). The Directigen A + B demonstrated sensitivity and specificity equivalent to the conventional kits in nasopharingeal aspirates. This kit can also differentiate influenza A and B viruses, a feature which is useful for treatment using anti-viral agents such as amantadine and neuraminidase inhibitor. To date, the kit is the most effective tool for the rapid diagnosis of influenza.     

Sensitivity and specificity of rapid influenza testing of children in a community setting

Please cite this paper as: Stebbins et al. (2011) Sensitivity and specificity of rapid influenza testing of children in a community setting. Influenza and Other Respiratory Viruses 5(2), 104–109. Introduction Rapid influenza testing (RFT) allows for a rapid point‐of‐care diagnosis of influenza. The Quidel QuickVue^® Influenza A+B test (QuickVue) has a reported manufacturer’s sensitivity and specificity of 73% and 96%, respectively, with nasal swabs. However, investigators have shown sensitivities ranging from 22% to 77% in community settings. Methods The QuickVue rapid influenza test was evaluated in a population of elementary (K‐5) school children, using testing in the home, as part of the Pittsburgh Influenza Prevention Project during the 2007–2008 influenza season. The QuickVue test was performed with nasal swab in full accordance with package instructions and compared with the results of nasal swab semi‐quantitative RT‐PCR. Results Sensitivity of the QuickVue was found to be 27% in this sample. There was no statistically valid correlation between the semi‐quantitative PCR result and the QuickVue result. Conclusions This study is consistent with the low sensitivity of the QuickVue test also reported by others. Viral load, technique, and the use of nasal swabs were examined as contributing factors but were not found to be explanations for this result. Community testing includes patients who are on the lower spectrum of illness which would not be the case in hospital or clinic samples. This suggests that RFT is less sensitive for patients at the lower spectrum of illness, with less severe disease.     

A case of fulminant type 1 diabetes mellitus after influenza B infection

A 64-years-old man referred to a hospital because of high-grade fever. He was diagnosed as having influenza B by "POCTEM Influenza A/B", a rapid influenza diagnostic kit which detect some antigens of influenza virus. Six days after medication of oseltamivir phosphate, his flu-symptoms disappeared, but he complained sever thirsty. And after 2days, he suffered from loss of consciousness and was admitted to the hospital. Laboratory data on admission showed diabetes ketoacidosis, slight elevation of HbA1c level despite sever hyperglycemia, and increase of serum amylase concentration. Anti GAD antibody and anti IA-2 antibody were not detected. Urinary C-peptide excretion was undetectable and serum C-peptide levels were also undetectable after glucagon and arginin load, suggesting disappearance of endogeneous insulin secretion. Class II HLA was susceptible to fulminant type1 diabetes. Based on these findings, we diagnosed him with fulminant type1 diabetes. In Japan, only three viruses in three cases have been reported to be the trigger in the development of fulminant type 1 diabetes. They were human herpes virus 6, herpes simplex virus and Coxsackie B3 virus. This is the fourth report of fulminant type 1 diabetes developed after the established diagnosis of viral infection and the first after influenza B virus infection. The fact that fulminant type 1 diabetes developed after the infection of such a common virus suggest that factors within host will play more important roles than virus itself in the etiology of fulminant type 1 diabetes.     

Burden of pediatric influenza A virus infection post swine-flu H1N1 pandemic in Egypt

ObjectiveTo screen children with influenza like illness or with symptoms of acute respiratory tract infections for influenza A virus infection — post swine flu pandemic era — using rapid influenza diagnostic tests.MethodsDuring two years (2010 & 2011), 1 200 children with influenza like illness or acute respiratory tract infections (according to World Health Organization criteria) were recruited. Their ages ranged from 2-60 months. Nasopharyngeal aspirates specimens were collected from all children for rapid influenza A diagnostic test.ResultsInfluenza A virus rapid test was positive in 47.5% of the children; the majority (89.6%) were presented with lower respiratory tract infections. Respiratory rate and temperature were significantly higher among positive rapid influenza test patients.ConclusionsInfluenza A virus infection is still a major cause of respiratory tract infections in Egyptian children. It should be considered in all cases with cough and febrile episodes and influenza like symptoms even post swine flu pandemic.     

Evaluation of the rapid detection test for influenza A and B viruses using neuraminidase activity

The ZstatFlu test (ZymeTx, USA) is a rapid detection kit for influenza A and B viruses. This test is based upon the reaction between viral neuraminidase from influenza viruses and a chromogenic substrate. The clinical performance of the ZstatFlu test was determined by comparison with viral isolation in cell culture. A total of 176 respiratory specimens from 172 pediatric patients with influenza like illnesses during the 1998/99 season were tested. Influenza viruses were recovered from 97 specimens (type A: 6, type B: 91) in cell culture. ZstatFlu demonstrated 67.4% sensitivity (29/43) and 62.7% specificity (37/59) for throat swabs. Of the 22 ZstatFlu-positive, culture-negative throat swabs tested by RT-PCR, 18 were positive by RT-PCR. ZstatFlu showed 48.1% sensitivity (26/54) and 90.0% specificity (18/20) for nasopharyngeal aspirates. Of the two ZstatFlu-positive, culture-negative nasopharyngeal aspirates tested by HI titer of paired sera, one showed a 4-fold increase of HI titer. Nasopharyngeal aspirates therefore showed lower sensitivity than throat swabs at this test, different from EIA test kits such as Directigen FluA or FLU OIA. Overall, only 5 specimens were false positive by the ZstatFlu test. Therefore, this test demonstrated high specificity and positive predictive value. In conclusion, the ZstatFlu test is useful for the rapid detection of influenza A and B viruses to identify patients who need antiviral treatment.     

Clinical performance of three rapid diagnostic tests for influenza virus in nasopharyngeal specimens to detect novel swine-origin influenza viruses

Background  

Influenza is an important public health problem. The aim of this study was to evaluate and compare the sensitivity and specificity of three rapid diagnostic tests (SEKISUI, QuickVue Influenza A + B, and SD BIOLINE) for novel swine-origin influenza viruses (S-OIV) and seasonal influenza.     

Optical immunoassay test for rapid detection of influenza A and B viruses: an evaluation

The optical immunoassay test (FLU OIA, BioStar, USA) for rapid detection of influenza A and B viral antigens was compared with viral isolation in cell culture. A total of 103 respiratory specimens were tested on 75 pediatric patients with acute respiratory illnesses. Influenza viruses were recovered in 40 specimens (type A: 5, Type B: 35). FLU OIA demonstrated 80.0% sensitivity and 68.8% specificity for nasopharyngeal aspirates and 36.7% sensitivity and 83.9% specificity for throat swabs. We also tested FLU OIA, retrospectively, using 78 supernatant samples from pediatric patients with influenza A virus infection frozen after cell culture. FLU OIA demonstrated 91.4% sensitivity and 92.3% specificity for nasopharyngeal aspirates and 50.0% sensitivity and 91.7% specificity for throat swabs diluted in viral transport media. Nasopharyngeal aspirates showed higher sensitivity than throat swabs for detection of influenza virus by FLU OIA. We believe this rapid test kit is useful for the detection of influenza A and B viruses.     

Isolation of influenza A H1N2 virus from a returning traveller at Nagoya International Airport

A reassortant influenza A H1N2 virus was isolated from a returning traveller arriving at Nagoya International Airport, Japan from Indonesia in May, 2002. A Hemagglutination inhibition test revealed that the virus was similar to a vaccine strain of A/NewCaledonia/20/99. A phylogenetic analysis demonstrated that the virus forms a cluster with other influenza A H1N2 viruses isolated in other countries. The reassortment event was theoretically assumed to have occurred between the 1999/2000 and 2000/2001 influenza seasons. Neither A H1N2 nor A H3N1 virus was detected from 256 isolates of AH1 or 177 of AH3 influenza viruses isolated in Aichi Prefecture, Japan between the 1999/2000 and 2001/2002 influenza seasons. This finding suggests the importance of influenza surveillance at an airport quarantine office to detect promptly a novel influenza virus penetrating to Japan.     

Diagnostics of viral respiratory infections in hospitalized patients and ambulatory patients from SENTINEL program during 2004/05 season in Poland

The aim of the study was to evaluate an impact of respiratory infections on the study population, type/subtype of influenza viruses circulating during 2004/05 season within the groups of hospitalised (n=35) and ambulatory patients (n=420) and to determine antigenic affinity of isolated viral strains. Laboratory diagnostics of influenza A and B type, RSV, adenovirus and parainfluenzavirus (type 1, 2 and 3) was performed using direct immunofluorescence test (DIFA), virus isolation on MDCK cell line and RT-PCR assay. Respiratory viruses were detected in about half of hospitalised patients and one fifth of ambulatory patients. Within these groups more than 80% hospitalised patients and 70% ambulatory patients were infected with influenza virus. Two influenza A subtypes (H3N2) and (H1N1) and B type were detected. Influenza ranged from 68,8% (26-45 age group) to 89,5% (15-25 age group) of all laboratory confirmed respiratory infections, only among the youngest children (0-3 years old) one fourth of infections was caused by influenza virus and in 50% samples RSV was detected. Influenza virus was also present in over 80% positive samples from hospitalised patients over 65 years old. Sensitivity of RT-PCR compared to other influenza diagnostic methods was 95% and specificity was > or = 99%. Fast and accurate influenza diagnostics using molecular biology methods enables implementing therapy with the new generation antivirals (neuraminidase inhibitors), that are effective only when administered up to 36-48 h from onset of the illness. In diagnostics of other. respiratory viruses it is necessary to apply more sensitive diagnostic methods e.g. multiplex RT-PCR. Influenza isolates were A/Wyoming/3/2003-like, B/Hong Kong/330/2001-like, A/New Caledonia/20/99-like and B/Jiangsu/10/2003-like strains that were components of influenza vaccines for 2003/04 and/or 2004/05 seasons. Annual vaccination remains the best way to prevent infection in high risk populations. Costs of influenza vaccine and oseltamivir prophylaxis in our country are on average respectively fifty and five times lower than each day of patients' stay at an intensiv care unit. Every year within the confines of global surveillance programs (e.g. SENTINEL), there are monitored circulating influenza viruses, in order to define vaccine composition for the next season and identify new and potentially pandemic strains.     

Patterns of shedding of myxoviruses and paramyxoviruses in children

In the Houston Family Study, young children were cultured for virus weekly or biweekly and during acute respiratory illnesses. The interval between the onset of illness and positive culture was examined for 179 infections during 1975-1979. In week 1 after onset, 73%, 73%, and 66% of cultures were positive for influenza A virus, respiratory syncytial virus (RSV), and parainfluenza virus type 3, respectively. Pooled data from influenza B virus infections in 1977 and 1980 showed that 73% of cultures were positive in week 1. Influenza A virus in week 2 or RSV in weeks 2 and 3 was isolated from very few children. However, 37% of cultures were positive for influenza B virus during week 2, and 17% of cultures were still positive for parainfluenza virus type 3 during week 3. Shedding of parainfluenza virus type 3 on days 29-38 was also observed. Parainfluenza virus type 3, RSV, and influenza A virus were isolated up to six days before the onset of illness.     

Lessons from the first year of the WAIVE study investigating the protective effect of influenza vaccine against laboratory-confirmed influenza in hospitalised children aged 6–59 months

Please cite this paper as: Dixon et al. (2010) Lessons from the first year of the WAIVE study investigating the protective effect of influenza vaccine against laboratory-confirmed influenza in hospitalised children aged 6–59 months. Influenza and Other Respiratory Viruses 4(4), 231–234. Background Influenza is major cause of paediatric hospitalisation. Influenza vaccine was offered to all children aged 6–59 months resident in Western Australia in 2008, and we wished to evaluate the effectiveness of this immunisation programme. Objectives To assess the practicalities of a nested matched case–control design to estimate the protective effect of inactivated influenza vaccination in hospitalised children aged 6–59 months. Methods Cases were hospitalised children with laboratory-confirmed influenza, while matched controls were recruited from children admitted for an acute non-respiratory illness. We estimated influenza vaccine effectiveness (VE) against influenza as 1 – the adjusted odds ratio from multivariate logistic regression. Results The 2008 influenza season was characterised by a late peak and a predominance of influenza virus B. We recruited 26 hospitalised patients with laboratory-confirmed influenza and 50 matched controls. The proportion of cases who were fully vaccinated was 7% versus 30% of controls giving an adjusted VE of 83% (95% CI −54 to 98). Conclusions Recruiting sufficient controls was problematic and in the future, we will select controls hospitalised for an influenza-like-illness but influenza negative by laboratory PCR testing. The VE estimate was high but non-significant, reflecting the low number of cases.     

Protective effects of influenza A (H1N1) pandemic 2009 vaccination against the onset of influenza-like illness and asthma exacerbation in Japanese children

Background: Vaccination against influenza A(H1N1)pdm09 in Japan started in October 2009. Children with asthma are considered as a high-risk group and are recommended to preferentially receive the vaccine. Objective: To identify the clinical effects of vaccination in Japanese children with and without asthma. Methods: We conducted a cross-sectional, questionnaire-based survey to compare vaccination rates, vaccine effectiveness against physician-diagnosed influenza A infection (PDIA), and consecutive asthma exacerbations between children with and without asthma. Results: Of the 460 children included in this study, those with asthma had higher vaccination rates (46.5%, 67/144) than those without asthma (30.4%, 96/316). Influenza A infections were diagnosed in 28 of 163 vaccinated children (17.2%) compared to 164 of 297 unvaccinated children (55.2%, p?Conclusions: The administration of an inactivated, split-virus, non-adjuvanted monovalent A(H1N1)pdm09 vaccine during the pandemic period reduced the number of physician-diagnosed influenza A infections and asthma exacerbations in children with asthma. Therefore, we strongly recommend that high-risk children with a history of asthma receive vaccines during pandemics.     

The post-infection outcomes of influenza and acute respiratory infection in patients above 50 years of age in Japan: an observational study

Please cite this paper as: Ikematsu et al. (2011) The post‐infection outcomes of influenza and acute respiratory infection in patients above 50 years of age in Japan: an observational study. Influenza and Other Respiratory Viruses 6(3), 211–217. Objectives  Influenza can be a serious illness, especially for older people, and reducing the impact of influenza in elderly is important. The objective of this study was to estimate the prevalence and postinfection outcomes of influenza among the over‐50 population in Japan. Design  An observational study was designed to ascertain the proportion of influenza cases in a population aged ≥50 years with acute respiratory infection (ARI) and to determine the postinfection outcomes of their illness during the 2008–09 influenza season in Japan. Respiratory specimens obtained from a total of 401 patients were tested by PCR for influenza viruses, respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The effectiveness of the seasonal trivalent influenza vaccine was estimated by a test‐negative case control analysis. Setting  Seventeen outpatient clinics located in four separate areas of Japan. Sample  Respiratory swab specimens from the ARI patients aged ≥50 years. Main outcome measures  Laboratory confirmed influenza in patients presenting with ARI. Results  In all, 89 (22.2%) of the patients were positive for one of the tested viruses; 70 (78.7%) with influenza, 17 (19.1%) with RSV, and 2 (2.2%) with hMPV. Cough (95.7% vs 73.4%), loss of appetite (67.1% vs 35.5%), absence from work (50.0% vs 23.0%), impact on daily activity (90.0% vs 62.5%), and caregiver absence from work (5.7% vs 0.6%) were observed higher in influenza patients. The duration of feeling weakness (6.3 ± 5.4 vs 3.6 ± 1.9 days) and average days of reduced activity (5.2 vs 3.6 days) were longer for influenza patients. Vaccine effectiveness was estimated to be 32.1% (95% CI: −14.9, 59.9%). Conclusions  Influenza was the dominant ARI‐causing virus and the clinical and socio‐economic outcomes imposed on patients over 50 years of age was high for influenza.