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Rapid Testing For Influenza
Influenza kills approximately 36,000 people in the United States each year. In addition to the annual toll of seasonal influenza, human fatalities caused by Influenza A virus H5N1 has reinforced the importance of monitoring influenza activity in the United States as part of pandemic preparedness. Several rapid influenza tests have been developed to diagnose influenza far more quickly than can be done with traditional viral cultures. There are eight FDA approved, commercially available waived1 rapid influenza tests that can be used in physician offices, emergency rooms and clinics to diagnose influenza. Although rapid influenza tests do not provide new influenza isolates to the public health system, they may aid in more accurate influenza diagnoses, which can increase the timely provision of antiviral therapy and prophylaxis, and decrease health care costs by minimizing laboratory tests, x-rays and antibiotic use.
This project is evaluating how, and how often, rapid influenza tests are implemented and used in outpatient medical settings (solo and group practice physician offices, community health centers, and acute care hospital emergency departments) throughout the United States; and identifying successful methods for implementing use of rapid influenza testing in a broad range of outpatient medical settings.
Members of the project’s technical advisory panel (TAP), public health officials and outpatient medical care providers will have access to the Wiki that has been created exclusively for this project, to share information and experiences with rapid influenza testing. Information exchanged may include: rationale for test use, problems with the testing process, strategies to overcome problems, staff training, quality assurance activities, and perceived advantages and disadvantages to the tests. The Wiki will also serve as a forum for outpatient care providers and public health officials to share information about their interactions and discuss ways to improve their linkages.
1. Tests can be categorized as "waived" from regulatory oversight if they meet certain requirements including ease of use established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law.
Surveys conducted during 1999--2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999--2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes.
Physician awareness of a rapid diagnosis of influenza in the pediatric emergency department significantly reduced the number of laboratory tests and radiographs ordered and their associated charges, decreased antibiotic use, increased antiviral use, and decreased length of time to discharge.
This is the first evaluation of integrating influenza rapid testing into public health surveillance (Hawaii). Coupling rapid tests with cultures appears to be an effective means of improving influenza surveillance.
Study concludes that rapid influenza testing leads to reductions in antibiotic use in hospitalized adults. Better tools
to rule out concomitant bacterial infection are needed to optimize the impact of viral testing.
When clinicians are planning to use the nonneuraminidase inhibitors
to treat influenza, rapid testing is not the most cost-beneficial approach. Even
when the more expensive neuraminidase inhibitors will be used, testing has a
limited role in managing influenza in high-risk patients.
Survey conducted with Primary Care Physicians (PCPs) identified that 69% of participating PCPs administered influenza tests to patients who had influenza-like illnesses during the influenza season and 53.8% prescribed antiviral agents, including two no longer recommended by CDC (i.e., amantadine & rimantadine).
Because the clinical diagnosis of influenza can be difficult, pediatricians often turn to rapid antigen tests to confirm a clinical suspicion of influenza. However, keep in mind that the predictive values of such tests vary with disease prevalence; despite the favorable sensitivity and specificity of most such tests, their positive predictive value is relatively low early and late in the influenza season. In addition, to gauge the predictive accuracy of a test in a particular setting, consider the degree of clinical suspicion as well as the frequency of influenza in the community at that time. Rapid influenza tests are most often helpful when the likelihood of influenza is intermediate (ie, in the early phase of influenza season when there is very strong clinical suspicion or during the peak of the season when there is moderate clinical suspicion).
BACKGROUND. Influenza rapid antigen detection (rapid tests) can provide timely identification of infection and aid in clinical decision-making. Although the interpretation of test results depends on test characteristics and influenza prevalence, this information is limited in routine clinical practice.
OBJECTIVE. We sought to assess the times at which rapid tests are most predictive of influenza infection.
METHODS. The New Vaccine Surveillance Network enrolled children aged < 5 years who were hospitalized with respiratory symptoms or fever from October 2000 through September 2004. Nasal and throat swabs were obtained, and influenza virus was detected by culture and reverse-transcription polymerase chain reaction. Provider-ordered rapid influenza tests were compared with the criterion standard (culture and reverse-transcription polymerase chain reaction) to determine their sensitivity and specificity. The New Vaccine Surveillance Network also enrolled children in outpatient settings during the 2002–2003 and 2003–2004 influenza seasons and determined the weekly influenza prevalence among symptomatic children. Trends in weekly predictive values of the rapid tests were estimated over the influenza seasons.
RESULTS. Rapid influenza tests had an overall sensitivity of 63% and specificity of 97%. In 2002–2003, the prevalence of influenza in symptomatic outpatient children peaked at 21% and stayed above 10% for 4 weeks. In contrast, in 2003–2004, influenza prevalence peaked at 60% and remained above 20% for 6 weeks. The positive predictive value of the rapid tests approached 80% when influenza prevalence was 15% but decreased to < 70% when influenza prevalence was < 10%.
CONCLUSIONS. Influenza prevalence varies between and within seasons. On the basis of our estimates, rapid tests are of limited use when prevalence is < 10%. The appropriate interpretation of rapid influenza tests requires local influenza surveillance and timely communication of this information to the practitioners.
In order to examine the impact of rapid influenza testing on the clinical treatment of children with influenza like illness (ILI), rapid influenza tests were administered to a large sample of children presenting in pediatric physician offices with ILI. Positive rapid tests results influenced the use of antiviral medications and decreased the use of unnecessary antibiotics.
This study examined the sensitivity and specificity of the QuickVue? Influenza A+B rapid influenza test among three different groups of children and young adults in three geographically distinct areas. The study found very low sensitivty for the test compared to reverse-transcriptase polymerase chain reaction, for detection of either the influenza A or influenza B virus. The specificity of the test was high.
A study was done to test the performance of various rapid influenza tests for the detection of the H1N1? influenza virus. Three rapid tests detected the H1N1? virus when it was present in high viral concentrations. Rapid tests are less sensitive than PCR assays and negative results should be verified with a laboratory test.
This study evaluated the performance of the Binax Now and 3MA+B rapid influenza tests, direct immunofluorescence (DFA), viral culture and polymerase chain reaction (PCR)for the detection of the novel H1N1 virus along with seasonal H1N1, H3N2 and other common circulating respiratory viruses. Although rapid tests require little technical skill, are fast and can be performed at the point of care, the sensitivity and specificity of the tests are questionable. The Binax NOW assay demonstrated poor sensivity for the detection of both seasonal influenza A (10.4%) and novel H1N1? (9.6%) when compared to R-Mix culture (99.6% and 99.0% respectively).
A RIDT may provide useful information that might impact on patient care. However, understanding the limitations of RIDTs is very important to appropriately interpret results for clinical management. When influenza viruses are circulating in a community, a positive test result indicates that influenza virus infection is likely present in the specimen. Knowledge of the presence of influenza A or B virus infection can help to inform influenza treatment decisions. However, a negative rapid test result does not rule out influenza virus infection. Since false negative results can occur, if clinical suspicion of influenza is high in a patient who tests negative by RIDT (or if RIDT is not offered), empiric antiviral therapy should be administered, if appropriate, and infection control measures implemented. In settings where policies indicate exclusion of patients who may have influenza (e.g., schools, camps, day care centers), a negative RIDT, performed on a patient with clinically compatible illness, should not be used as justification for early return to that setting. Finally, a negative RIDT result can not exclude influenza as a cause of an outbreak in a facility with ill residents or patients with clinically compatible illness.
The specificity of RIDTs is generally high. However, especially during periods of low influenza activity (e.g. the very beginning of the season), false positive results can occur. During low influenza activity periods, confirmation of positive RIDT results by another testing method such as viral culture or rRT-PCR should be considered.