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Point of Care Strep Tests Speed Treatment, Lower Costs

Beta-hemolytic group A streptococcus (S. pyogenes) is the most common bacterial agent associated with upper respiratory tract infections. Although it usually involves mild symptoms (such as headache, fever or abdominal pain) if left untreated streptococcal infection can worsen and become life-threatening. Early diagnosis and treatment of group A streptococcal pharyngitis has been shown to reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis. Given the risks, physicians often rely on a presumptive clinical diagnosis.

The conventional methods used to confirm group A streptococcal infection depend on the isolation and identification of the organism on blood agar plates. These methods usually require 18-24 hours of incubation at 37C. This delay in identifying group A streptococcus has often caused physicians to administer therapy without first knowing the etiological agent. Alternatively, the development of the rapid antigen detection test (RADT) has allowed the identification of group A streptococcal carbohydrate on a throat swab in a matter of minutes.

This prompt, point-of-care test has proven a valuable resource in the office management of patients with pharyngitis. RADT has improved the appropriateness of antibiotic therapy and allowed earlier laboratory, evidence-based treatment of group A -hemolytic streptococcal pharyngitis.

Despite the widespread use and broadly demonstrated accuracy of rapid testing, some controversy remains in the clinical community about the need for agar incubation culture as a confirmatory procedure following a positive RADT and prior to the initiation of antibiotic therapy or as a reassay in those instances when RADT results are negative yet clinical findings support a diagnosis of Strep-A infection. In such instances, the perceived need for dual testing can actually increase the overall cost of diagnosis. On balance, however, RADT appears to have accelerate d accurate diagnosis and treatment and to have lowered costs. Furthermore, research on the validity of rapid strep tests without follow-up throat cultures suggests that there is no difference in the complication rate between patients tested with a rapid test over a throat culture.

Thirty-five CLIA-waived antigen tests that test directly from throat swabs are currently available from 26 different biomedical firms, making this assay the most broadly produced point of care diagnostic kit. Among the most popular RADT products are:

  • The ACON Strep A Twist Rapid Test Device (Throat Swab) from ACON Laboratories, Inc. San Diego, Calif., is a lateral flow test in device format, utilizing a patented design to provide convenience to the user. Specimen extraction is performed directly a built-in swab chamber, eliminating the need for test tubes and reducing the number of steps. This test exhibits a 93 percent accuracy compared to plate culture.

  • The QuickVue In-Line Strep A Test from Quidel Corporation, San Diego, Calif., also allows for the rapid detection of group A streptococcal antigen directly from patient throat swab specimens. Two-color results provide clear readability. The 25 test kit package is stored at room temperature and includes positive and negative external controls.

  • The OSOM Ultra Strep A Test from Genzyme, Cambridge, Mass., is a color immuno-chromatographic assay that detects either viable or nonviable organisms directly from a throat swab, providing results within seven minutes. Genzyme says that the product has a demonstrated 96 percent sensitivity and specificity.

  • The Biostar Acceava Group A Strep test produced by Thermo Electron Corporation, Waltham, Mass., delivers excellent sensitivity and specificity with a simple, easy-to-use test that reports a result in five minutes or less. The company claims that this test is significantly more sensitive with low to moderat e positives than other CLIA waived rapid antigen tests. The test is performed by adding reagents to a test tube, inserting the throat swab, waiting several minutes and then inserting and reading the test results strip. Thermo says that the hands-on time for the test is about one minute. The product can be stored at room temperature.

Given the commodity nature of RADT products and their similarity of use and reliability, the purchasing decision largely rests on factors such as established vendor relationships, the purchasers confidence in vendor reliability and quality, cost, and ease of access. Whichever product is ultimately chosen, the use of this assay has become a ubiquitous improvement in the primary care setting and, research findings indicate, has contributed to timely, cost-effective patient care.

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