Rapid Streptococcal Antigen Detection Test Performed by Parents of Children with Sore Throat

 

 

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Abstract

Summary:
Background. Sore throat in children is among the most common of medical problems to result in a primary care office visit. A rapid point-of-care antigen detection test for group A streptococcal pharyngitis is already in routine office use in clinical facilities but not generally available to the public. We tested the hypothesis that parents themselves would be able perform the rapid strep test for their children and thereby be able to avoid, when medically appropriate, the cost and inconvenience of an office visit.
Methods. In a pediatric clinic serving a 25,000-member university community, parents of patients ages 5 to 16 with the presenting problem of sore throat or upper respiratory infection were invited to participate in our study. If a rapid strep test was indicated, participating parents performed the throat swabbing and strep test while being observed by a clinic staff member. Regular clinic protocol was then followed for subsequent bacterial culture and antibiotic treatment.
Results. Among 120 parents invited to participate, 76 agreed and 71 successfully performed the throat swabbing and rapid strep test. Most of the participants were confident or at least somewhat confident in their swabbing and testing.
Conclusions. If the parents of these children had been able to perform the rapid step test in their homes, visits to the clinic could have been avoided; no school or work time would have been lost; and physicians and clinic staff could have focused their efforts on more emergent needs, all without compromise to these patients.
Keywords: Rapid strep test, sore throat, home diagnosis.
Citation: Finkelstein SN, Horowitz GL, Diamond DV, et al. Rapid streptococcal antigen detection test performed by parents of children with sore throat. J Participat Med. 2017 Mar 25; 9:e5.
Published: March 25, 2017.
Competing Interests: The authors have declared that no competing interests exist.

Introduction

Sore throat in children is among the most common of medical problems to result in a primary care office visit.[1] The annual economic burden of this condition in school age children is substantial and has been estimated to be as much as $539 billion in the United States alone.[2] Although complications of untreated group A streptococcal pharyngitis, in particular rheumatic fever and glomerulonephritis, are fortunately in decline, eradication of the causal streptococci when detected is still important therapeutically.[3]

If an easily performed and accurate diagnostic process for streptococcal throat infections were available to parents in their homes, this could facilitate early detection and treatment, while reducing the financial burden to the health care system. The result, together with the child’s clinical condition, could be communicated by telephone or email to the responsible clinician to allow appropriate initial triage. A positive result would lead to antibiotic treatment, a negative result to appropriate symptomatic management. Office visits would be needed only for those patients with worrisome symptoms or other considerations where parent or clinician decided a direct encounter would be advised. Using such a triage approach, children and parents could avoid the time and expense of what would be unnecessary office visits and absences from work and school, and use of visits when necessary would be more efficient.

In recent years, research with tests to detect bacterial protein antigens has led to effective diagnostic tests for certain bacterial infections.[4] A rapid point-of-care antigen detection test for group A streptococcal pharyngitis (“rapid strep test”) is already in routine office use in clinical facilities.[5] Performed manually, with a throat swab then inserted into an antigen detection solution, the test yields results within 10 minutes. With specificity close to 98 percent and sensitivity close to 90 percent, the rapid antigen detection test is useful in making timely clinical decisions about antibiotic treatment.[6]

Although rapid antigen detection kits are available to the public over the Internet, it is not known how often or how well these tests are used, and in the United States, their sanctioned use is currently limited to licensed clinicians, who are required by law to establish competency to perform the test. In our study presented here, we set about to test our hypothesis that parents could themselves learn to perform properly the rapid strep test for their children.

Methods

Our study was conducted in the Pediatrics Service of the Massachusetts Institute of Technology’s (MIT’s) Medical Department. This Service offers clinical care for children and adolescents in the approximately 25,000-member university community of faculty, families of faculty, employees and students.

The parents of patients ages 5 to 16 with the presenting problem of sore throat or upper respiratory infection were invited by the greeting support staff to consider participating in the study. Those expressing interest were handed a computer tablet with which they could view a 3-minute video produced for this study about rapid strep testing while waiting to see the clinician. The video explained the objectives of testing and described the procedures of swabbing the throat and performing the test on the resulting sample.

During the visit with the clinician, the parent and patient underwent the standard medical history and examination appropriate to the presenting problem. If the clinician determined that rapid strep testing was indicated, parents having agreed to participate in the study were asked to sign the Institutional Review Board (IRB)-approved informed consent document, and the assent of the child was also obtained. When a parent or child declined, the clinician or medical assistant performed the test, per standard clinic practice.

The test used in our study was a single reagent diagnostic product (OSOM Ultra Strep A Test, Seksui Diagnostics, San Diego, CA), FDA approved for use by medical professionals (CLIA license holders). Participating parents obtained swabs (two swabs in a single swabbing action) of their child’s throat, the standard practice in the MIT clinic, and performed the test with one of the swabs under the direct observation of the clinician or medical assistant who assessed the adequacy of the swabbing and testing procedure. If either were judged to be deficient, the clinic staff member repeated the procedure.

Patients having positive rapid strep tests, indicating high likelihood of presence of group A streptococcus, were prescribed antibiotic medication, and the specimen swab was not sent to the clinic lab. No bacterial culture was taken. When a test was negative, one of the two swabs was sent to the lab for culture, again the standard practice at MIT, and treatment with medication was deferred until the culture results were available, usually within 48 hours. In all instances, parents were cautioned to contact or return to the clinic if the patients’ symptoms had not improved after two days.

The study protocol was approved by the Committee on the use of Humans as Experimental Subjects, the IRB serving MIT.

Results

Of 120 parents invited to participate, 76 agreed. Among the 76 parents who attempted the swabbing, 71 were able successfully to obtain a throat swab and perform the rapid strep test. One parent who succeeded in swabbing asked the clinic staff member also to perform the test; and the swabs of four parents were deemed unsuitable. Among the 71 parents completing the process, 40 were confident and 29 somewhat confident in their swabbing; and 57 were confident and 14 somewhat confident in performing the test.

Of the 71 rapid strep tests performed, 54 were negative and 17 were positive. All 54 negative samples were sent to the lab for bacterial culture, of which one returned positive, resulting in a 1.9% false negative rate. These represented just under 40% of the 137 throat cultures performed on all patients aged 5-16 who were seen in the Pediatrics Service during our study period. The child with the negative rapid strep test but positive culture had remained symptomatic and was prescribed an antibiotic once the culture results were available, the standard practice at MIT.

Discussion

Among the parents who participated in our study, more than 93% were able to swab their child’s throat and perform the rapid strep test successfully. Given the clinical presentations of these children, if the test had been used in their homes, many of the parents and children would have been able to avoid a clinical office visit and avoid missing work and school. When the test results were positive, and depending on the circumstances of the illness, clinicians might well have been comfortable in sending a prescription for antibiotics directly to the pharmacy and in following the patient’s progress by telephone or electronic mail over a secure patient portal.[7] When the test results were negative, the parents could have waited two days without risk and then contacted or visited the clinic if the child’s sore throat failed to improve, which occurred in the single instance when the negative rapid strep test was followed by a positive culture for streptococcus.[8]

In the unlikely event that a test was improperly performed at home, the ill child would still be protected if the parent had been advised, by either the clinic’s protocol or the instructions accompanying the rapid strep test, to bring the child to the clinic for care after two days if there had been no improvement. Published literature confirms that antibiotic treatment for streptococcal sore throat begun within ten days of symptoms mitigates any risk of post-streptococcal cardiac or renal complications.[9]

It has long been our belief that patients and their families are the largest and least well-utilized resource for contributing to the provision of high quality healthcare, and that efforts should be made when possible to welcome and empower patients and their families, more as colleagues in the health care process than as passive-dependent recipients.[10][11][12][13] Our results suggest strongly that the rapid strep antigen test can be another effective means to this end, joining such currently home-used diagnostic measures as tests for pregnancy and for glucose monitoring. We believe that in the future, many parents will choose to perform home testing to avoid, when medically appropriate, the cost and inconvenience of an office visit.

A large pediatrics group practice led by one of the authors (L.H. Hartman) has worked out a detailed protocol to offer parents access to perform the rapid strep antigen test at home. They found that parental use of the test reduced the number of acute, non-urgent clinic visits for sore throat by 27.5%, compared to an 8.4% reduction in a control site. The reduction in visits for sore throat made over 1000 visit slots available for obesity management and care of other chronic conditions in the practice as well as allowing children with sore throats to be diagnosed and treated in a more timely and convenient fashion.[14]

Effort will be needed, however, to expand the awareness of the rapid strep antigen test and to corroborate our belief that home use would be in the best interests of patients, their families, and their clinicians. Although widespread use of the test could have an adverse effect on the finances of clinics relying primarily on fee-for-service for income, home use of the test could be of great interest to clinics serving self-insured populations or participating in alternative insurance contracts that reward quality and value in the provision of care rather than the number of visits per se. Further study of the costs and benefits of parental use of rapid strep tests when their children experience sore throat should be undertaken in different populations and in different health care reimbursement systems.

Manufacturers of rapid strep antigen test kit products will need to realize greater market potential if their products are to be made readily available for home use; and regulatory agencies will need to lower their administrative barriers to widespread use. We hope that by providing data on the safety and efficacy of parental use of the test, our study will be helpful in this process.

References

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  14. Hartman LJ, Fischer JS, Halle K, et al. Building capacity for the medical home: managing acute and chronic conditions in the primary care setting. Available at: http://www.wmpeds.com/wp-content/uploads/2016/06/NICHQ-presentation-UPDATED-48×42.pdf. Accessed March 24, 2017.

    Copyright: © 2017 Stan N. Finkelstein, Gary L. Horowitz, David V. Diamond, Pat Bartels, Jocelyn Joseph,
    Lester Hartman, Jeffrey Blander, and Warner V. Slack. Published here under license by The Journal of Participatory Medicine. Copyright for this article is retained by the authors, with first publication rights granted to the Journal of Participatory Medicine. All journal content, except where otherwise noted, is licensed under a Creative Commons Attribution 3.0 License. By virtue of their appearance in this open-access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.

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