Background Timely diagnosis of influenza can help clinical management. Purpose To examine the accuracy of rapid influenza diagnostic tests (RIDTs) in adults and children with influenza-like illness and evaluate factors associated with higher accuracy. Data sources PubMed and EMBASE through December 2011; BIOSIS and Web of Science through March 2010; and citations of articles, guidelines, reviews, and manufacturers. Study selection Studies that compared RIDTs with a reference standard of either reverse transcriptase polymerase chain reaction (first choice) or viral culture. Data extraction Reviewers abstracted study data by using a standardized form and assessed quality by using Quality Assessment of Diagnostic Accuracy Studies criteria. Data synthesis 159 studies evaluated 26 RIDTs, and 35% were conducted during the H1N1 pandemic. Failure to report whether results were assessed in a blinded manner and the basis for patient recruitment were important quality concerns. The pooled sensitivity and specificity were 62.3% (95% CI, 57.9% to 66.6%) and 98.2% (CI, 97.5% to 98.7%), respectively. The positive and negative likelihood ratios were 34.5 (CI, 23.8 to 45.2) and 0.38 (CI, 0.34 to 0.43), respectively. Sensitivity estimates were highly heterogeneous, which was partially explained by lower sensitivity in adults (53.9% [CI, 47.9% to 59.8%]) than in children (66.6% [CI, 61.6% to 71.7%]) and a higher sensitivity for influenza A (64.6% [CI, 59.0% to 70.1%) than for influenza B (52.2% [CI, 45.0% to 59.3%). Limitation Incomplete reporting limited the ability to assess the effect of important factors, such as specimen type and duration of influenza symptoms, on diagnostic accuracy. Conclusion Influenza can be ruled in but not ruled out through the use of RIDTs. Sensitivity varies across populations, but it is higher in children than in adults and for influenza A than for influenza B. Primary funding source Canadian Institutes of Health Research.

Accuracy of rapid influenza diagnostic tests: a meta-analysis.

and specificity were 62.3% (95% CI, 57.9% to 66.6%) and 98.2% (CI, 97.5% to 98.7%), respectively. The positive and negative likelihood ratios were 34.5 (CI, 23.8 to 45.2) and 0.38 (CI, 0.34 to 0.43), respectively. Sensitivity estimates were highly heterogeneous, which was partially explained by lower sensitivity in adults (53.9% [CI, 47.9% to 59.8%]) than in children (66.6% [CI, 61.6% to 71.7%]) and a higher sensitivity for influenza A (64.6% [CI, 59.0% to 70.1%) than for influenza B (52.2% [CI, 45.0% to 59.3%). Limitation: Incomplete reporting limited the ability to assess the effect of important factors, such as specimen type and duration of influenza symptoms, on diagnostic accuracy. Conclusion: Influenza can be ruled in but not ruled out through the use of RIDTs. Sensitivity varies across populations, but it is higher in children than in adults and for influenza A than for influenza B. Primary Funding Source: Canadian Institutes of Health Research.

Accuracy of Rapid Influenza Diagnostic Tests

SUMMARY The world had been anticipating another influenza pandemic since the last one in 1968. The pandemic influenza A H1N1 2009 virus (A/2009/H1N1) finally arrived, causing the first pandemic influenza of the new millennium, which has affected over 214 countries and caused over 18,449 deaths. Because of the persistent threat from the A/H5N1 virus since 1997 and the outbreak of the severe acute respiratory syndrome (SARS) coronavirus in 2003, medical and scientific communities have been more prepared in mindset and infrastructure. This preparedness has allowed for rapid and effective research on the epidemiological, clinical, pathological, immunological, virological, and other basic scientific aspects of the disease, with impacts on its control. A PubMed search using the keywords “pandemic influenza virus H1N1 2009” yielded over 2,500 publications, which markedly exceeded the number published on previous pandemics. Only representative works with relevance to clinical microbiology and infectious diseases are reviewed in this article. A significant increase in the understanding of this virus and the disease within such a short amount of time has allowed for the timely development of diagnostic tests, treatments, and preventive measures. These findings could prove useful for future randomized controlled clinical trials and the epidemiological control of future pandemics.

https://cmr.asm.org/content/cmr/25/2/223.full.pdf

Two Years after Pandemic Influenza A/2009/H1N1: What Have We Learned?

Background Rapid and accurate influenza diagnostics can improve patient care. Purpose To summarize and compare accuracy of traditional rapid influenza diagnostic tests (RIDTs), digital immunoassays (DIAs), and rapid nucleic acid amplification tests (NAATs) in children and adults with suspected influenza. Data sources 6 databases from their inception through May 2017. Study selection Studies in English, French, or Spanish comparing commercialized rapid tests (that is, providing results in Data extraction Data were extracted using a standardized form; quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) criteria. Data synthesis 162 studies were included (130 of RIDTs, 19 of DIAs, and 13 of NAATs). Pooled sensitivities for detecting influenza A from Bayesian bivariate random-effects models were 54.4% (95% credible interval [CrI], 48.9% to 59.8%) for RIDTs, 80.0% (CrI, 73.4% to 85.6%) for DIAs, and 91.6% (CrI, 84.9% to 95.9%) for NAATs. Those for detecting influenza B were 53.2% (CrI, 41.7% to 64.4%) for RIDTs, 76.8% (CrI, 65.4% to 85.4%) for DIAs, and 95.4% (CrI, 87.3% to 98.7%) for NAATs. Pooled specificities were uniformly high (>98%). Forty-six influenza A and 24 influenza B studies presented pediatric-specific data; 35 influenza A and 16 influenza B studies presented adult-specific data. Pooled sensitivities were higher in children by 12.1 to 31.8 percentage points, except for influenza A by rapid NAATs (2.7 percentage points). Pooled sensitivities favored industry-sponsored studies by 6.2 to 34.0 percentage points. Incomplete reporting frequently led to unclear risk of bias. Limitations Underreporting of clinical variables limited exploration of heterogeneity. Few NAAT studies reported adult-specific data, and none evaluated point-of-care testing. Many studies had unclear risk of bias. Conclusion Novel DIAs and rapid NAATs had markedly higher sensitivities for influenza A and B in both children and adults than did traditional RIDTs, with equally high specificities. Primary funding source Quebec Health Research Fund and BD Diagnostic Systems.

Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Infection Compared With Reverse Transcriptase Polymerase Chain Reaction: A Systematic Review and Meta-analysis

Summary: The menu of diagnostic tools that can be utilized to establish a diagnosis of influenza is extensive and includes classic virology techniques as well as new and emerging methods. This review of how the various existing diagnostic methods have been utilized, first in the context of a rapidly evolving outbreak of novel influenza virus and then during the different subsequent phases and waves of the pandemic, demonstrates the unique roles, advantages, and limitations of each of these methods. Rapid antigen tests were used extensively throughout the pandemic. Recognition of the low negative predictive values of these tests is important. Private laboratories with preexisting expertise, infrastructure, and resources for rapid development, validation, and implementation of laboratory-developed assays played an unprecedented role in helping to meet the diagnostic demands during the pandemic. FDA-cleared assays remain an important element of the diagnostic armamentarium during a pandemic, and a process must be developed with the FDA to allow manufacturers to modify these assays for detection of novel strains in a timely fashion. The need and role for subtyping of influenza viruses and antiviral susceptibility testing will likely depend on qualitative (circulating subtypes and their resistance patterns) and quantitative (relative prevalence) characterization of influenza viruses circulating during future epidemics and pandemics.

Update on Influenza Diagnostics: Lessons from the Novel H1N1 Influenza A Pandemic

We evaluated the SD Bioline Influenza Ag A/B/A(H1N1) Pandemic test kit and compared it with real-time reverse transcriptase PCR (RT-PCR) for its ability to detect H1N1 2009. The sensitivity and specificity of the test kit for H1N1 2009 were 77% and 100%, respectively.

https://journals.asm.org/doi/pdf/10.1128/JCM.02392-09

Evaluation of New Rapid Antigen Test for Detection of Pandemic Influenza A/H1N1 2009 Virus

Background : Chagas' disease is caused by Trypanosoma cruzi, a protozoan parasite, which is transmitted by blood-sucking bugs or through blood transfusion or organ transplantation. It is endemic in Central and South America. The objective of this study was to compare the performance of immunochromatographic SD Bioline Chagas Ab Rapid (Standard Diagnostics, Korea) with three immunochromatographic kits for the detection of antibodies to T. cruzi. Methods : A total of 320 serum specimens (140 positive and 180 negative) from National Reference Laboratory for Chagas and Leishmaniasis (NRLCL, Honduras) were used for the evaluation of four different test kits: SD Bioline Chagas Ab Rapid, Chagas Stat-Pak Assay (Chembio Diagnositc Systems, USA), OnSite Chagas Ab Rapid test-Cassette (CTK Biotech, USA), and Trypanosoma Detect Rapid Test (InBios International, USA). The results of four kits were compared with those of NRLCL. Cross-reactivity with other parasites was also evaluated. Results : Compared with the results of NRLCL, sensitivity and specificity were 99.3% and 100% for both of SD and Chembio kits, 97.2% and 100% for InBios kit, and 97.9% and 98.8% for CTK kit. None of other parasites showed cross-reactivity. Conclusions : SD Bioline Chagas Ab Rapid kit showed test results highly correlating with those of National Reference Laboratory for Chagas and Leishmaniasis. It can be used for a rapid detection of Chagas' disease in endemic region and monitoring the disease among overseas travelers in Korea.

Evaluation of SD BIOLINE Chagas Ab Rapid kit

Objectives The aim of this study was to develop an immunochromatographic assay (ICA) for the detection of influenza A (H1N1) pdm09 virus infection. Materials and methods Several monoclonal antibodies against influenza A (H1N1) pdm09 virus were generated and an ICA (pdm09-ICA) was developed for the rapid and specific detection of influenza A (H1N1) pdm09 virus infection. The specificity and sensitivity of the developed assay were compared with that of hemagglutination assay and real-time reverse-transcription polymerase chain reaction (rRT-PCR). Results The detection limit was estimated to be 1/2 (8) hemagglutinating unit; the sensitivity and specificity rates of pdm09-ICA were 75.86% (110/145) and 100% (43/43), respectively, compared with rRT-PCR. The cross-reactivity for 20 influenza viruses, including seasonal H1N1 viruses, was found to be negative except for the H1N1 virus (A/Swine/Korea/GC0503/2005). Conclusion These results indicate that the proposed method can be easily used for rapid and specific detection of the pdm09 infection. The assay developed in this study would be a useful tool for distinguishing the pdm09 infection from seasonal influenza A and B infections.

Development of a Specific and Rapid Diagnostic Method for Detecting Influenza A (H1N1) pdm09 Virus Infection Using Immunochromatographic Assay.

Nosemosis is caused by the obligate intracellular and spore-forming parasites, Nosema apis (N. apis) and Nosema ceranae (N. ceranae), which attack the lining of the mid-gut of worker, queen or drone honeybee. In this study, new PCR method for the specific detection of Nosema apis in honeybees was developed and is termed as a Nosema apis specific PCR. Nosema apis specific primers (NoA (Nosema apis) F2/No R2) were designed based on N. apis small subunit ribosomal RNA gene (Accession no.U97150.1) in which shown lower homology compared to N. ceranae (Accession no. DQ486027). NoA specific DNA fragment 430-bp was generated by artificial synthetic method with long oligonucleotides and constructed into T vector. Recombinant clone was named pBXNoA_ ssrRNA that has 99% homology to reference sequence of N. apis. In here, it demonstrated that specific NoA primer set is able to achieve specific detection and verification of N.apis whereas no amplified to N. ceranae. This PCR method may be expected to be useful tool for rapid, specific detection of N.apis in field and for the monitoring of natural infection in Apis mellifera and Apis cerana.

Mi Jung Ji

Papers

Evaluation of New Rapid Antigen Test for Detection of Pandemic Influenza A/H1N1 2009 Virus

Evaluation of SD BIOLINE Chagas Ab Rapid kit

Development of a Specific and Rapid Diagnostic Method for Detecting Influenza A (H1N1) pdm09 Virus Infection Using Immunochromatographic Assay.

Development of Specific PCR Method for Detection of Nosema apis Based on Nucleotide Sequence