Xpert® Xpress Strep A
Xpert® Xpress Strep A (10-test kit)
XPRSTREPA-10
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Collection devices
Collection and Transport System, Eswab 480CFA (1 box of 50)
480CFA
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1. What does the Xpert Xpress Strep A test for?
1. What does the Xpert Xpress Strep A test for?
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.
2. Can the test monitor treatment for Group A Streptococcus infection?
2. Can the test monitor treatment for Group A Streptococcus infection?
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.
3. What are Group A streptococci?
3. What are Group A streptococci?
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).
4. What other bacteria may cause Pharyngitis?
4. What other bacteria may cause Pharyngitis?
Pharyngitis may also be caused by other bacteria including Neisseria gonorrhoeae and Corynebacterium diphtheriae, for which specific culture methods are required.
5. Is there a need for culture confirmation of negative Xpert Xpress Strep A results?
5. Is there a need for culture confirmation of negative Xpert Xpress Strep A results?
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. Additional 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).
6. What are the acceptable sample type options in allowed patient care settings?
6. What are the acceptable sample type options in allowed patient care settings?
The Xpert Xpress Strep A has been validated only with throat swabs using Cepheid’s recommended procedure per package insert. (1)
7. What are the acceptable collection devices for Xpert Xpress Strep A?
7. What are the acceptable collection devices for Xpert Xpress Strep A?
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)
8. What external quality control (QC) material options are available for Xpert Xpress Strep A?
8. What external quality control (QC) material options are available for Xpert Xpress Strep A?
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 for use in Moderately Complex environments 301-6574 (MC), CLIA-waved 302-2294 (CW), for use with GeneXpert with Touchscreen 303-0929.
