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Xpert® Xpress Strep A
Qualitative real-time PCR test providing accurate detection of Group AStreptococcusin as soon as 18 minutes.
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10 Tests
XPRSTREPA-CE-10
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Collection devices
Collection and Transport System, Eswab 480CFA (1 box of 50)
480CFA
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The Need
To accurately diagnose pharyngitis caused by Group A Streptococcus (GAS) due to increasing incidence and prevalence globally.
- Annually, 616 million people have GAS pharyngitis, more than 18.1 million people develop severe GAS disease and more than 517,000 people die due to severe GAS disease.1
- Literature shows 37% of children who presented with pharyngitis tested positive for GAS, however 56% of visits were associated with antibiotic prescriptions. Similarly, 18% of adults presented with pharyngitis caused by GAS, but 72% were treated with antibiotics.2
(1) The Global Burden of Group A Streptococcal Diseases. Lancet Infect Dis. 2005 Nov; 5(11):685-94.
(2) Fleming-Dutra KE, et al. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73.;
(3) Workflow studies conducted by Cepheid Solutions demonstrate that a throat culture confirmation workup costs~ $9.13 per culture. (Average cost includes reagents, labor cost and time). Data on file.
(4) Shulman ST, et al. Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82.
(2) Fleming-Dutra KE, et al. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73.;
(3) Workflow studies conducted by Cepheid Solutions demonstrate that a throat culture confirmation workup costs~ $9.13 per culture. (Average cost includes reagents, labor cost and time). Data on file.
(4) Shulman ST, et al. Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82.
The Solution
- Cepheid provides on-demand testing for Group A Strep in as soon as 18 minutes.*
- Careful selection of the target gene produces quality results
- Delivering accurate and timely results optimizes fast treatment decisions and eliminates the need to perform culture confirmation of negative results.
* Full test runtime is 24 minutes. Positive results available in as soon as 18 minutes with early assay termination.
The Impact
- Accurate diagnosis of GAS supports antimicrobial stewardship and may reduce the amount of patients inappropriately prescribed antibiotics.
- Gain testing efficiencies and reduce costs by eliminating culture confirmation testing.3, 5
- Reduce the risk of GAS complications such as rheumatic fever and glomerulonephritis.
- Improve patient satisfaction with quicker time to result and appropriate prescriptions.
(3) Workflow studies conducted by Cepheid Solutions demonstrate that a throat culture confirmation workup costs~ $9.13 per culture. (Average cost includes reagents, labor cost and time). Data on file.
# Follow-up testing by culture is required if the Xpert Xpress Strep A test result is negative and clinical symptoms persist, or there is an outbreak of acute rheumatic fever (ARF).
# Follow-up testing by culture is required if the Xpert Xpress Strep A test result is negative and clinical symptoms persist, or there is an outbreak of acute rheumatic fever (ARF).
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Product Resources
Product Information
Package Inserts & MSDS
Video
GeneXpert® Xpress System Video
Educational Materials
Antibiotic Stewardship in the Emergency Department
This webinar discusses the importance of diligent antimicrobial stewardship and accuracy of diagnostic tests for the detection of Group A Streptococcus pharyngitis. It provides commentary on the high confidence that molecular testing affords the antibiotic steward and how technology can reduce the practice of prescribing antibiotics "just-in-case" there is an infection, especially as testing moves closer to the patient.
More...
Strep A Diagnostics: Advances in Testing to Improve Patient Outcomes
More...
Frequently Asked Questions
The Xpert Xpress Strep A test, performed on the GeneXpert® Instrument Systems, is a rapid, qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The Xpert Xpress Strep A test can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The test is not intended to monitor treatment for Group A Streptococcus infection.
Group A streptococci are gram-positive, beta-hemolytic bacterial pathogens that commonly cause infections in the throat (pharyngitis or “strep throat”) or on the skin (cellulitis and impetigo) and can cause a wide range of other serious infections (e.g., sepsis, pneumonia, and meningitis). If left untreated, mild infections can lead to more serious infections. The most severe but least common forms of invasive Group A streptococcal disease are necrotizing fasciitis and streptococcal toxic shock syndrome (STSS). Untreated post-infection sequelae can also occur (e.g., rheumatic fever).
Pharyngitis may also be caused by other bacteria including Group C/G streptococci, Archanobacterium haemolyticum and viral etiologies, such as common respiratory viruses causing the common cold and EBV (i.e. Mono). Detection and identification of other streptococci and A. haemolyticum requires culture. Detection of viral pharyngitis is often by NAAT or other serological methods (e.g., EBV).
No, Xpert Xpress Strep A test does not require culture confirmation. It is a rapid PCR test for the qualitative detection of Group A streptococci from throat swab specimens without the need for culture confirmation of negative Xpert Xpress Strep A results. For negative samples, the time to result is 24 minutes. For positive samples, the time to result can be as early as 18 minutes.
The Xpert Xpress Strep A has been validated only with throat swabs using Cepheid’s recommended procedure per package insert. (1)
The acceptable collection device is Copan Liquid Amies Elution Swab (ESwab™) Collection and Transport System. The following ESwab collection kits may be used: Copan 480CE, Copan 480C, or Copan 480CFA. (1)
There are two external controls recommended in the IFU from ZeptoMetrix for this test, NATSPY-6MC (Positive Control) and NATSDG-6MC (Negative Control). For appropriately certified labs (e.g. CLIA-certification to perform moderately complex testing), many other vendors offer commercially available alternative quality control materials in addition to the ZeptoMetrix controls listed in the IFU If a laboratory sources alternative materials for external quality control, it is their responsibility to ensure that material performs as expected with the Xpert Xpress Strep A test. External controls should be used in accordance with local and state accrediting organizations, as applicable. (1)
References
1.Xpert® Xpress Strep A Package Insert. 301-6574, Rev. F. Accessed March 10, 2023 https://www.cepheid.com/en-CAntent/dam/www-cepheid-com/documents/package-insert-files/Xpert%20Xpress%20Strep%20A%20ENGLISH%20IFU%20301-6574%20Rev%20F.pdf