CEPHEID SOLUTIONS SERVICES

Why GeneXpert?

• It is on-demand point of care molecular testing.
• Allows office laboratories and rural and global hospitals access to:
• Accurate
• Reliable
• Fast results
• Timely answers prevent patients from being treated empirically while waiting for definitive results

The Basics

• Every Xpert test cartridge is compatable with the GeneXpert System.
• The systems are upgradeable in a one, two, four, 16, 48, or 80 module configuration.
• Room temperature storage

The specimen is collected with the appropriate method and a sample is inserted into the cartridge specific to the test ordered

The cartridge is inserted into the Xpert system to be resulted

Results are complete in 30min to 2 hours and sent to any computer that the software has been loaded to

AVAILABLE TESTS

• Chlamydia and Gonorrhea
• Trichomonas Vasinalis
• Antenatal and Intrapartum Group B Strep
• Flu A, Flu B, and/or RSV testing
• CLIA-waived Flu, and RSV testing
• Strep A
• C-Diff
• C-diff/Epi (epidemid 027 strain)
• MRSA multiple
• Carba-R
• Norovirus
• VRE
• MTB/RIF (TB)
• EV (Enteroviral meningitis)
• FII and FV (Genetic risk of Thrombosis)

Pros

• NO batching
• NO send outs
• Reimbursed by Medicare/Medicaide
• Rapid
• Saves money
• Saves time
• No emperical treatments
• Accuracy

Cons

• Cost is still prohibitive in low-income countries
• Hospitals with laboratories may not invest in redundant, but faster technology
• Not all tests are available in the United States

What Studies are Showing

• “The MTB/RIF test can effectively be used in low-resource settings to simplify patients' access to early and accurate diagnosis, thereby potentially decreasing morbidity associated with diagnostic delay, dropout and mistreatment.”
• Boehme, C., Nicol, M., Nabeta, P., Michael, J., Gotuzzo, E., Tahirli, R., & ... Cox, H. (2011).

What Studies Show

• A 2013 study in a teritary hosptial found that after using the Cepheid Xpert C difficile assay the rate of C difficile detection doubled. Leading to an abrupt 70% increase in the overall rate of C difficile in the hospital.
• Leading to an abrupt 70% increase in the overall rate of C difficile in the hospital.
• Williamson, D. A., Basu, I., Freeman, J., Swager, T., & Roberts, S. A. (2013)

Future Practice

• The CDC reports in 2016
• 1.59million cases of Chlamydia
• 468,514 cases of Gonorrhea
• Chlamydia and Gonorrhea
• The rate of antibiotic resistant STDs are increasing
• Patients with STDs are high-risk and are traditionally non-compliant with follow-up and treatment courses (Levesque, 2016).
• Rapid test results could limit empirical treatments AND treat the patient before they left the office
• The highest rates of STD are individuals
• The GeneXpert has a high sensitivity for patient collected swabs (brochure).

REFERENCES

• McMillen, T., Usiak, S. C., Chen, L. H., Gomez, L., Ntiamoah, P., Hameed, M. R., & ... Babady, N. E. (2018). Evaluation of the Xpert MTB/RIF Performance on Tissues: Potential Impact on Airborne Infection Isolation at a Tertiary Cancer Care Center. Infection Control & Hospital Epidemiology, 39(4), 462-466. doi:10.1017/ice.2018.7
• Donà, M. G., Rollo, F., Pichi, B., Spriano, G., Pellini, R., Covello, R., & ... Benevolo, M. (2017). Evaluation of the Xpert® HPV assay in the detection of Human Papillomavirus in formalin-fixed paraffin-embedded oropharyngeal carcinomas. Oral Oncology, 72117-122. doi:10.1016/j.oraloncology.2017.07.016
• Boehme, C., Nicol, M., Nabeta, P., Michael, J., Gotuzzo, E., Tahirli, R., & ... Cox, H. (2011). Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet, 377 North American Edition(9776), 1495-1505. doi:10.1016/S0140-6736(11)60438-8
• Wilson, S. P., Vohra, T., Goldberg, J., Price, C., Calo, S., Mahan, M., & Miller, J. (2017). Reliable Rapid Assay for Gonorrhea and Chlamydia in the Emergency Department. Journal Of Emergency Medicine (0736-4679), 53(6), 890-895. doi:10.1016/j.jemermed.2017.08.094
• Williamson, D. A., Basu, I., Freeman, J., Swager, T., & Roberts, S. A. (2013). Improved detection of toxigenic Clostridium difficile using the Cepheid Xpert C difficile assay and impact on C difficile infection rates in a tertiary hospital: a double-edged sword. American Journal Of Infection Control, 41(3), 270-272. doi:10.1016/j.ajic.2012.03.025
• CEPHEID RECEIVES FDA CLEARANCE, CLIA WAIVER FOR XPERT FLU+RSV XPRESS TEST. (2016). Clinical Laboratory News, 42(2), 24.

Collect specimen-- Stool, soft tissue, sputum, blood, urine, vaginal swabs, endocervical swabs, nasal swab, nasal wash, etc and place in cartridge specific to the test

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• Xpert® MRSA Xpert® SA Nasal Complete Xpert® C. difcile Xpert® C. difcile/Epi Xpert® vanA for VRE Xpert® MRSA/SA SSTI Xpert® MRSA/SA BC Xpert® Norovirus Xpert® MTB/RIF Xpert® EV Xpert® Flu Xpert® Flu/RSV XC Xpert® Ebola* Xpert® CT/NG Xpert® GBS Lim Broth Xpert® GBS Xpert® FII & FV
• Carba-R Group A Strep Trichomonas HIV Viral Load Breast CA Stratier BCR-ABL Ultra
• Pertussis HPV GBS Ultra HCV Viral Load HBV Viral Load CMV Viral Load Bladder CA Monitor Bladder CA Symptomatic

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• Collect specimen-- Stool, soft tissue, sputum, blood, urine, vaginal swabs, endocervical swabs, nasal swab, nasal wash, etc and place in cartridge specific to the test

How it Works

• Results are complete in 30min to 2 hours and sent to any computer that the software has been loaded to
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CEPHEID SOLUTIONS SERVICES