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. 2021 Nov 8;16(11):e0259593. doi: 10.1371/journal.pone.0259593

Table 3. Routine implementation of the Cepheid CT/NG GeneXpert in different healthcare service settings.

Care setting Study design and location Target population Test Implementation Impacts assessed Results
Sexual health services GeneXpert test implementation and time to treatment comparison with same target population. San Francisco City STI Clinic, USA. May-Dec 2018. Cohen et al. 2019. Asymptomatic MSM and transwomen attending follow-up care for HIV PrEP; those who were sexual contacts of someone with CT/NG were excluded GeneXpert implementation as standard of care among MSM and transwomen

  1. Mean and median time to treatment

  1. 90 patients were NG/CT positive. After introduction of POCT, mean and median time to NG/CT treatment decreased from 6 and 4 days to 1.7 and 0 days (p<0.001)
Comparison of standard care with “sample-first” (prior to consultation) pathway and use of in-house GeneXpert testing on patient management. Courtyard Clinic, St George’s University Hospitals NHS Foundation Trust, London UK. Harding-Esch et al. 2017. Males and females symptomatic for CT/NG infection; sexual contacts of CT/NG positive patients Standard triage procedure followed by self-collected sample provided by patients prior to clinical consultation. GeneXpert testing, routine culture and microscopy, and non-NAAT POCTs for TV and BV. Results provided to patients in clinical consultation

  1. Proportion of patients who responded in favour of the ‘sample first’ approach

  2. Proportion of patients who received test results in the same clinical visit

  3. Individual durations of patient pathway component parts (triage, recruitment, sample collection, clinician consultation, discharge from clinic)

  1. 95.8% (23/24) of patients found self-sample provision prior to clinical consultation acceptable; no patients refused

  2. 78.6% (55/70) of patients did not wait for POCT results before leaving clinic

  3. GeneXpert results (CT/NG negative) led to: two females avoiding presumptive treatment; one male receiving treatment for possible Mycoplasma genitalium infection
Implementation of GeneXpert in specialist sexual health clinic symptomatic service in London, UK. No dates given. Mandlik et al. 2017. Subset of 100 symptomatic patients diagnosed with CT/NG GeneXpert implementation as standard of care

  1. Time from attendance to treatment

  2. Modelled number of partners not exposed due to earlier CT/NG treatment of index patient

  1. Time to treatment reduced by 66% (6.2 days) from 9.5 days pre-implementation to 3.3 days post-implementation.

  2. 54% fewer partners were exposed to CT/NG (19.9 pre-implementation and 9.12 post- implementation)
Retrospective review of patients’ notes in sexual health clinic after GeneXpert introduction, London, UK. No dates given. Whitlock et al. 2015. Patients diagnosed with CT/NG Service redesign involving express screening service, including sexual history on touchscreen computers, self-collected samples, POC testing and automated results management

  1. Time to treatment

  1. Of 431 CT and/or NG diagnoses, time to treatment reduced by 190 hours
Comparison of data between Dean Street Express (DSE; a walk-in, rapid STI screening service for asymptomatic individuals) and 56 Dean Street (56DS; standard off-site laboratory-based NAAT testing), London, UK, in one-year period from 1 June 2014 to 31 May 2015. Whitlock et al. 2018. Patients attending DSE and 56DS. Data extracted from patient notes of first 12 patients (MSW, MSM and women) GeneXpert implementation as standard of care at DSE. Sexual history is provided by patients on a touchscreen computer, which orders the relevant swabs based on self-reported sexual history. Patients self-collect swabs/samples, which are delivered to and processed on-site GeneXpert. Health adviser reviews sexual history, collects blood for off-site syphilis, HIV and/or hepatitis B/C testing (results within 4 hours). Treatment for test-positive patients is provided at 56DS

  1. Time from sample collection to notification of GeneXpert test results

  2. Modelled reduction in partner notification and treatment (for partners exposed to CT/NG)

  3. Modelled cost to clinics of fewer attendances for screening and treatment of partners

  4. Modelled potential public health impact due to transmissions averted

  1. Time from sample collection to notification of GeneXpert test results for 138,261 test notifications reduced by 8.68 days between 56DS [8.95 days (95% CI 8.91–8.99 days)] and DSE [0.27 days (95% CI 0.26–0.28 days)]

  2. Estimated 854 partner attendances averted

  3. Estimated annual savings of £124,283 (IQR £4260–590,331) due to reduced partner attendances

  4. Estimated 196 CT and/or NG transmissions averted
Comparison of standard care and use of in-house GeneXpert testing and results notification pathway. Dean Street Express clinic, Chelsea and Westminster Hospital NHS Foundation Trust, London UK. 19 April 2013–7 January 2014. Wingrove et al. 2014. Males and females asymptomatic for CT/NG infection GeneXpert introduced into clinic for on-site testing

  1. Median time from testing to treatment for positive patients

  2. Median time to informing of results for negative and positive patients

  3. Median time from informing positive patients of results to treatment

  1. Median time from testing to treatment for patients with positive results (n = 28) was 2 days (IQR 1–6 days) with GeneXpert and 10 days (IQR 7–11 days) for standard care

  2. Median time to informing of negative results (n = 50) was 1 day (IQR 1–2 days) for GeneXpert and 12 days (IQR 8–14 days) for standard care. Median time from testing to patient result delivery for positive patients was 1 day (IQR 1–3 days) with GeneXpert and 8 days (IQR 7–9 days) for standard care

  3. Median time from informing patients to treatment was 1 day (IQR 0–2 days) with GeneXpert and 1 day (IQR 1–4 days) for standard care
General Practice and other non-sexual health specialist services Assessment of introducing newly available STI POCTs and treatment. Alotau, Milne Bay Province, Papua New Guinea. August—December 2014. Badman et al. 2016 Females ≥18 years attending their first clinic antenatal visit Face to face interview with nurse: demographic and sexual behaviour data collection. Routine antenatal and provider-initiated HIV (Alere Determine HIV1/2) and syphilis (SD Bioline anti TP 3.0) screening via rapid test; Syphilis rapid test followed by confirmatory laboratory test. Self-collected vaginal swabs with on-site testing for CT/NG and TV (Cepheid GeneXpert) and BV (BV Blue). Positive patients (as needed): same-day antibiotic treatment; risk-reduction counselling; contact tracing

  1. Impact of introducing newly available STI POCTs on patient waiting times

  2. Proportion of patients receiving same-day results

  3. Proportion of participants positive for infection

  4. Time to treatment; Proportion of positive patients receiving same-day treatment

  5. Reasons for leaving prior to treatment

  1. Integration of study procedures into routine clinic activities resulted in an average of two hours’ additional waiting time per patient

  2. All participants (n = 125) received same-day results

  3. 53.6% (67/125) of patients had CT, NG, TV or BV; of these 71.6% (48/67) were asymptomatic

  4. Of those with an infection, 83.6% (56/67) received same-day treatment. All received treatment within one week.

  5. Reasons for leaving prior to treatment included family commitments, and the need to travel significant distances back to their homes by foot or by bus
Assessment of introducing GeneXpert into two university hospital family planning clinics: Antoine Béclère Hospital (Clamart, France) and Avicenne Hospital (Bobigny, France), July 2012—Jan 2013. Bourgeois-Nicolaos et al. 2015. Women presenting to the clinics for induced abortion, intrauterine device insertion as emergency contraception, or signs of STI, were consecutively recruited Patient samples sent for GeneXpert testing in hospital’s laboratory. Test results reported to clinic by phone and/or fax. Patients with positive results were immediately telephoned and prescription faxed to their closest pharmacy. Prescriptions for partners, or letter to partner’s physician, provided

  1. Test success rate

  2. Proportion of patients receiving CT/NG result before termination procedure

  1. The rate of GeneXpert assay success was 98.3% (581/591) test success (not intermediate/invalid result) on first attempt

  2. 100% of patients received appropriate treatment pre-termination procedure, compared with 40% with standard NAAT
Assessment of GeneXpert implementation in Haitian Study Group for Kaposi’s sarcoma and Opportunistic Infections (GHESKIO) clinics. GHESKIO provides “integrated primary care services, including HIV counselling, AIDS care, antenatal care, and management of tuberculosis and STIs.” Port-au-Prince, Haiti, 26 Oct 2015–14 Jan 2016. Bristow et al. 2017. Pregnant women ≥18 years attending GHESKIO clinics Participants self-collected samples, which were tested by GeneXpert as standard of care. Women returned to GHESKIO within 7 days to receive test results and treatment if test-positive

  1. Proportion of patients consenting to participate (acceptability)

  2. Proportion of infections treated (feasibility)

  1. 300/322 (93.2%) women consented to testing

  2. 122/133 (91.7%) infections were treated
Assessment of GeneXpert test implementation in Prince Cyril Zulu Communicable Disease Centre (PCZCDC), a large public healthcare clinic that provides “general primary health care services for adults free of charge” in Durban city centre, KwaZulu-Natal, South Africa, May 2016—Jan 2017. Garrett et al. 2018. HIV-negative women, at high HIV risk, aged 18–40 years, attending PCZCDC for STI care Implementation of GeneXpert, Trichomonas vaginalis (TV) (OSOM® Rapid Trichomonas Test), and bacterial vaginosis (BV) (Gram stain microscopy) to evaluate how expedited partner therapy (EPT) introduction could be accelerated through use of POCTs. Results available within 2 hours. Test-positive women were immediately treated and offered EPT packs. STI-positive women invited to participate in focus group discussions on POC testing and EPT. An EPT questionnaire was administered by telephone at one-week follow-up. Women were retested for STIs in the clinic after 6 and 12 weeks.

  1. Proportion of STI-positive women accepting EPT

  2. Proportion of STI-positive women successfully delivering EPT at one-week FU

  3. Acceptability and feasibility

  1. 62/63 (98.4%) women with an STI were offered EPT, and 54/62 87.1% accepted

  2. At telephonic follow-up one week later, 48/54 (88.9%) reported successfully delivering EPT to partner at one-week follow-up (77.8% [42/54] observed; (11.1% [6/54] unobserved)

  3. In focus group discussions, women (n = 29) reported being in favour of the new care model acceptable and supported the care model because “they received a rapid, specific diagnosis, and could facilitate their partners’ treatment”
Randomised controlled trial in an urban academic emergency department (ED), USA. April 2015—May 2016. Gaydos et al. 2019. Women undergoing pelvic examinations and CT/NG testing as part of their ED standard of care Control: standard-of-care CT/NG NAAT, with 2- to 3-day turnaround time.Intervention: rapid GeneXpert test, in addition to the standard-of-care NAAT. Rapid results immediately provided, and treatment provided to all patients according to providers’ clinical judgment

  1. Proportion of patients under-treated

  2. Proportion of patients over-treated

  3. Length of stay

  1. Undertreatment for CT/NG was 0% for the intervention group (0/10 & 10/5) and 43.8% (6/13 and 4/7) for the control group

  2. Clinicians unnecessarily provided treatment for CT in 46.5% (53/114) of uninfected control group participants compared with 23.1% (27/117) of intervention group participants. Clinicians unnecessarily provided treatment for NG in 46.7% (56/120) of control group participants compared with 25.4% (31/122) of intervention group participants

  3. The length of stay did not differ significantly between groups
Cross-over cluster randomised controlled trial of routine GeneXpert implementation to improve infection management (intervention; n = 6 health services) compared to standard care (control; n = 6 health services). Primary health services that provide care to Indigenous people in regional or remote locations in Western Australia, Far North Queensland, and South Australia. June 1, 2013—Feb 29, 2016. Guy et al. 2018. Patients aged 16–29 years attending participating health services in a 12-month period Health services were provided training for use of the GeneXpert and equipment, supplies for ≤150 GeneXpert tests; participating services were reimbursed for retesting (Further details provided [52])

  1. Primary outcome: proportion of patients found to have CT or NG who had a positive result at retesting 3 weeks to 3 months after treatment

  2. Secondary outcomes:

  3. Proportion of infections treated within 7 days of sample collection date;

  4. Proportion of patients who were given treatment on the same day as testing

  5. Proportion of patients who were given treatment within 2 days of testing

  6. Proportion of patients who were given treatment within 7 days of testing

  7. Proportion of patients who were given any treatment within 4 months of a positive CT/NG test result

  8. Staff acceptability

  9. Patient acceptability

  1. Proportion of positive-test individuals retested between 3 weeks and 3 months after treatment was: 14% (63/455) in intervention group (19%; 12/63 had positive retest result) versus 17% (67/405) in control group (13%; 9/67 had a positive retest result)

  2. Of all individuals with a positive test in the intervention group, 76% (347/455) were treated within 7 days compared with 47% (191/405) in the control group (absolute across-cluster difference of 29%)

  3. In the intervention group, 49% (221/455) were given treatment on the same day as testing compared with 27% (111/405) in the control group

  4. In the intervention group 60% (274/455) of patients were treated within 2 days, compared with 30% (122/405) in the control group

  5. In the intervention group 76% (347/455) of patients were treated within 7 days, compared with 47% (191/405) in the control group

  6. In the intervention group 94% (427/455) of patients were treated within 4 months, compared with 86% (347/405) in the control group

  7. Clinical staff (N = 35) found GeneXpert testing highly acceptable

  8. Patient acceptability surveys (N = 80) indicated a high degree of satisfaction with GeneXpert testing
Randomised controlled trial in an urban ED, Washington DC, USA, Oct 2013—Oct 2014. May et al. 2016. Symptomatic patients presenting to an urban ED, and where treating provider was ordering diagnostic CT/NG test Control: standard-of-care CT/NG NAAT, with results available within 1–4 days Intervention: rapid GeneXpert test, with results provided during ED visit. Treatment was provided at ED provider’s discretion. After patient discharge, treating physician filled out a clinician survey

  1. Antibiotic overtreatment rates

  2. Treatment adherence

  3. Symptom resolution 7 to 10 days post-discharge

  4. Results notification

  5. Healthcare utilisation and charges, and total ED charges

  1. Clinicians unnecessarily provided treatment for CT and/or NG to 11/20 (55.0%) control group participants, compared with 8/37 (21.6%) intervention group participants (P = 0.01)

  2. intervention group participants were less likely to report missed antibiotic doses (Risk Difference [RD], −51.3%; 95% CI, −84.4% to −18.2%; Risk Ratio [RR], 0.23; 95% CI, 0.06–0.88)

  3. No differences were found in symptom resolution 7 to 10 days post-discharge between intervention and control group participants

  4. Intervention group participants were more likely to be notified of their results (RD, 50.6%; 95% CI, 22.7%–78.5%; RR, 2.72; 95% CI, 1.26–5.86)

  5. There were no significant differences in healthcare charges or utilisation, or total ED charges
Assessment of GeneXpert introduction in antenatal clinic (ANC), Kinshasa, Kisantu health zone, Democratic Republic of Congo. No dates given. Mvumbi et al. 2017. Pregnant women attending ANC Trained clinic staff collected observed if women presented with STI symptoms, and collected vaginal swabs. Samples were tested using GeneXpert CT/NG and TV tests

  1. Proportion symptomatic patients STI-positive

  2. Proportion asymptomatic patients STI-positive

  1. 10/352 (2.8%) women were symptomatic; 5/10 (50%) were CT/NG/TV positive

  2. 50/342 (14.6%) asymptomatic patients were CT/NG/TV positive
Comparison of patients tested with GeneXpert C to a historical control group tested using a traditional NAAT in an urban community teaching hospital ED, Dec 2014–Jan 2015. Rivard et al. 2017. Patients ≥15 years of age who were tested for NG/CT GeneXpert implementation as standard of care. Test-positive patients who received results prior to ED discharge were provided with notification, counselling, and treatment on-site. For patients whose results were not available pre-discharge, providers could offer empiric treatment and then follow-up with results post- discharge

  1. Percentage of patients who received appropriate initial treatment during their index ED visit (test-positive patients receiving antimicrobial therapy in concordance with the CDC guidelines and test-negative patients not receiving antimicrobial treatment)

  2. Factors independently associated with appropriate treatment

  3. Time to test results

  4. Time to patient notification of positive test results

  5. Time to appropriate treatment

  6. Cost of appropriate and inappropriate treatment

 200 consecutive patients tested by GeneXpert compared with 200 historical patients tested with traditional NAAT.

  1. 60% of patients received appropriate initial treatment in the historical group, compared with 72.5% in the GeneXpert group (P = 0.008). This was predominantly due to avoiding unnecessary treatment test-negative patients

  2. CT/NG test availability prior to discharge was the only factor associated with appropriate treatment (odds ratio [OR], 22.65 [95%CI, 2.86–179.68, P = 0.003])

  3. Median time to test results was 2.4 hours (1.4–12.0) in the GeneXpert group compared with 31.7 hours (9.7–105.9) in the historical group (P<0.001)

  4. Median time to patient notification of positive test results was 17.4 hours (0.0–93.0) in the GeneXpert group compared with 53.7 hours (26.9–79.9) in the historical group (P = 0.010)

  5. Mean time to appropriate treatment for test-positive patients was 4.9 ± 21.3 hours in the GeneXpert group compared with 23.0 ± 56.3 hours in the historical group

  6. GeneXpert testing cost $343,566 over the study duration compared with $348,457 in the historical group, saving $4891 ($24.46 per patient)
Assessment of GeneXpert implementation in Princess Marina Hospital ANC (the main government referral hospital for southern Botswana), Gaborone, Botswana, July—October 2015. Wynn et al. 2016. Women receiving antenatal care at the clinic, who were aged ≥18 years, gestational age <35 weeks, mentally competent and willing to return to clinic for follow-up care Women self-collected vaginal swabs, which were tested on-site in the ANC vitals room by GeneXpert for CT, NG, and TV. Women received same-day test results notification, in-person or by telephone. Test-positive women received same-day treatment prior was to leaving clinic

  1. Acceptability of intervention

  2. Feasibility of intervention

  3. Treatment uptake

  1. 200/225 (89%) eligible women accepted to participate.

  2. 100% of eligible women were successfully tested for CT, NG and TV, and received same-day results. 143 (72%) women received results in-person prior to leaving clinic, and 57 (29%) were contacted by telephone after leaving the clinic (6 [10.5%] of these were test-positive and returned to clinic for treatment)

  3. 100% of test-positive women were successfully treated, 80% immediately
Assessment of GeneXpert introduction in one main clinic and three sex-on-premises venues (SOPV) where regular outreach HIV/syphilis POC testing had been taking place, within an urban community context, Brisbane, Australia, 3 March 2017–14 June 2018. Bell et al. 2020. Prospective consecutive sampling of asymptomatic patients (predominantly MSM), ≥16 years, presenting at any of the four included locations. Patients reporting potential HIV exposure within the past 72 hours of attendance were excluded Pilot of peer-delivered, community-led service providing POC CT/NG testing. GeneXpert implementation as standard of care in included settings. Participants self-collected samples, which were tested by GeneXpert at main clinic. Participants received their CT/NG results by telephone or SMS within 24 h. Test-positive participants referred for treatment, either in-clinic or elsewhere (community-based services, sexual health services, regular GP and non-regular GP). Peer test facilitators conducted follow-up telephone interviews with test-positive participants 2 weeks post-referral for retesting and treatment. Additional online ‘Post-Referral Survey’ for test-positive participants at 2-week post-testing follow-up interview phone call.

  1. Acceptability and feasibility

  2. Time to results notification

  3. Proportion of treated patients

  4. Proportion of contacts

  5. Estimated additional number of CT/NG infections detected

  1. CT/NG POCT accepted on 93.4% (4523/4843) occasions; 99.3% of patients accepted on their first visit. Uptake varied by setting: 93.8% (4051/4318) at clinic vs. 89.9% (472/525) from the three SOPVs combined (P<0.001). Post-Referral Survey and Evaluation Survey results indicated patients found the service acceptable, accessible, and would recommend the service.

  2. 604/614 (98.4%) test-positive participants received their result and were referred for treatment within 24 h of testing. Ten (1.6%) were ‘lost to follow up’

  3. 89.7% (70/78) of participants reported receiving treatment

  4. Post-referral, 64.1% (50/78) of participants reported informing all their contacts

  5. Estimated 117 CT and 66 NG infections would not have been identified if the service was not offering CT/NG testing
Outreach services Assessment of GeneXpert implementation in a mobile healthcare van at an annual community event in a metropolitan area with high STI prevalence. 2012 and 2013, no specific location given. Hesse et al. 2015. Males and females ≤14 years All specimens were self-collected in the van. Participants with positive results were notified and prescribed treatment. Questionnaire to assess acceptability of test turnaround times and self-sample collection

  1. Treatment delivery rates

  2. Patient acceptability of testing

  1. 2/12 (16.6%) females and 0/10 (0%) males were CT positive and none were NG positive using GeneXpert testing. 1/2 (50%) positive patients was notified of her results and received same-day treatment

  2. 30 participants (20 females; 10 males) completed the questionnaire. Sample collection was as acceptable in a van as in the doctors’ office; faster turn-around-times for STI testing results were considered the most acceptable
Assessment of GeneXpert introduction and same-day CT/NG treatment. May 2017 to June 2019, Los Angeles California and New Orleans Louisiana, USA. Keizur et al. 2020. Young people ages 12–24 years with high sexual risk behaviours, recruited online and in advertisements in homeless shelters, lesbian, gay, bisexual, and transgender organizations and community health centres in Los Angeles, California, and New Orleans, Louisiana USA Every 4 months, within a 24-month enrolment period, participants attended clinic and self-collected pharyngeal, rectal, and urine or vaginal samples for CT/NG testing using GeneXpert. Positive patient management: Before March 2018 in Los Angeles and November 2018 in New Orleans: participants were referred to a local clinic or their primary care doctor for treatment. After March 2018 in Los Angeles and between 12 November 2018 and 28 February 2019 in New Orleans: participants were offered same-day treatment and expedited partner therapy packs by study staff

  1. Proportion of participants who received same-day treatment

  2. Participants’ median time to treatment

  3. Number of partner treatment packs taken by participants

  4. Any reported adverse treatment-related events

  1. The proportion of participants receiving same-day CT and NG treatment increased from 3.6% (5/140) pre-intervention to 21.1% (20/95) post-intervention

  2. Median time to treatment decreased from 18.5 days pre-intervention to 3 days post-intervention

  3. 37.9% (n = 36) participants took a median of 1 partner treatment pack each (range 1–3; 48 total)

  4. No reported treatment-related adverse events
Assessment of GeneXpert implementation in four community-based settings in Harare, Zimbabwe, participating in CHIEDZA trial (Community based interventions to improve HIV outcomes in youth), June 2019—Jan 2020. Martin et al. 2021. All youth, aged 16–24 years, accessing CHIEDZA services. GeneXpert testing within 48 hours of first-catch urine sample provision. Participants able to collect test result the following week, with positive-test participants actively followed-up.

  1. STI testing uptake

  2. Proportion of test-positive participants treated

  3. Proportion of test-positive participants symptomatic.

  4. Contacts traced and treated

  5. Factors associated with testing uptake

  1. Uptake was 33·3% (1478/4440; 95% CI 31·9–34·7); 30·4% (294/967) in men and 34·1% (1184/ 3473) in women

  2. 67% (165/248) test-positive participants treated

  3. 3% (7/248) test-positive participants symptomatic and received syndromic management

  4. 87/248 (35.1%) partners attended for treatment

  5. Current STI symptoms were independently associated with testing uptake. Uptake also motivated by potential to be treated if positive, and perceived risk based on their own or partner’s sexual behaviour. Stigma and lack of confidentiality were barriers to testing.
Assessment of GeneXpert implementation in urban Walk In Ruhr (WIR) inter-institutional care centre, Germany, Dec 2016 –July 2018. Skaletz-Rorowski et al. 2020. Asymptomatic youth (14–30 years) approached in schools, universities and youth centres attending sexual health education lectures; sample collection took place at WIR inter-institutional care centre GeneXpert platform implemented within WIR centre. Samples tested by nurses or doctors immediately after collection Turn around time (TAT) was defined as the interval between
when the swabs were provided to the patient to the time communication of the result to the patient.

  1. Median turnaround time (TAT) (time between swab provision and patients receiving results)

  2. Time between test and starting treatment

he interval between
initiation of test to initiation of therapy was additionally documented.		 272 participants (133 males, 133 females).

  1. Median TAT was 3:09 hours; 91.8% received their positive test result within 24 hours, and 95.7% within 48 hours. This compares with standard TAT of 72 hours

  2. Median time between test and starting treatment was 6:50 hours; 73.3% received initial treatment within 24 hours, and 86.7% within 48 hours. This compares with standard time to treatment of approximately 120 hours

73.3% with a positive result received initial treatment within 24 h and 86.7%
within 48 h

[47, 52–72].