Reiniging en desinfectie van ruimten Module 3 Evidence-tabellen

Amodio (2014)

Type of study

Cross-sectional study

Setting and country

Hospital, Italy

Funding and conflicts of interest

Not reported

Inclusion criteria

- Randomly selected, proportionally to the size of the hospital unit
- Tables, lockers, and furnishings (e.g., bed, chairs) in patient’ and healthcare workers’ rooms
- Morning (7:00 a.m. to 11:00 a.m.)
- 2 hours after sanitisation

Exclusion criteria
None

Surfaces
Total: N=193

Other important characteristics

Type of surface
- Table: n=89 (46%)
- Locker: n=50 (26%)
- Furnishing: n=54 (28%)

Index test

ATP Adenosinetrifosfaat (Adenosinetrifosfaat) bioluminescence assay

Cut-off point(s)
Not defined

Method
- Lumicontrol II (PBI International, Milano, Italy)
- Swab, close zig-zag pattern
- Size of area sampled: 100 cm² (10x10 cm)
- Unit of measurement: relative light unit ( RLU Relative Light Unit (Relative Light Unit))

Reference test

Microbiological culture: aerobic colony count (ACC)

Cut-off point(s)*
- 2.5 CFU/cm²

Method
- Slide with plate count agar
- Slide pressed for 15 seconds onto the surface
- Size of area sampled: ~24 cm² (slide diameter 55 mm)
- Incubation: aerobic, 37^oC, 48 hours
- Visual colony count
- Unit of measurement: colony forming unit (CFU)

Time between the index test and reference test

Simultaneously

Distance between sampling site for index test and reference test

Adjacent

Incomplete outcome data

N=0 (0%)

Reasons for incomplete outcome data

Not applicable

Correlation

ATP values (log¹⁰RLU/cm²) vs. ACC (CFU/cm²):

Pearson’s rho=0.54

R²=0.29

The authors conclude that ATP bioluminescence is a quick and sensitive test that can be a useful proxy of microbial contamination.

No standardisation of contamination level. This may have resulted in reduced precision (difference in contamination level between adjacent surface areas).

Area size sampled for reference test 25% of that sampled for index test. This lower sensitivity of the reference test may have resulted in false-negative results at low contamination levels and an overestimation of the correlation with the ATP bioluminescence method.

Blinding of outcome assessment not reported for reference test.

No incomplete data reported. It is considered unlikely that there were none.

Outcome correlation is no measure of agreement.

95% CI of Pearson’s rho not reported.

Trsan (2019)

Type of study

Cross-sectional study

Setting and country

Hospital, Slovenia

Funding and conflicts of interest

Not reported

Inclusion criteria

- Randomly selected
- Surfaces in farmacy rooms
- Different parts of the workday
- No prior extensive cleaning

Exclusion criteria
None

Surfaces
Total: N=537
Category 1: n=109
(LAF cabinet cleanroom)

Category 2: n=150
(Clean room)

Category 3: n=70
(Filter anteroom)

Category 4:n=208
(Other: lab office, storage, packaging)

Other important characteristics

Type of surface
- Laminar airflow (LAF) cabinet in cleanroom (category 1): n=109 (20.3%)
- Cleanroom (category 2): n=150 (27.9%)
- Filter in cleanroom (category 3): n=70 (13.0%)
- Other (not cleanroom) (category 4): n=208 (38.7%)

Index test

ATP bioluminescence assay

Cut-off point(s)*

Category 1:
70 RLU/20 cm²

Category 2:
140 RLU/20 cm²
210 RLU/20 cm²

Category 3:
340 RLU/20 cm²
510 RLU/20 cm²

Category 4:
510 RLU/20 cm²
2,000 RLU/20 cm²
4,000 RLU/20 cm²

Method
- Lumitester PD-30 (Kikkoman Biochemica Company, Tokyo, Japan)
- LuciPac Pen swabs (Kikkoman Biochemica Company, Tokyo, Japan)
- Size of area sampled: 24 cm² (6x4 cm)
- Unit of measurement: relative light unit (RLU)
- Triplicate measurement

Reference test

Microbiological culture

Cut-off point(s)*

Category 1:
1 CFU/20 cm²

Category 2:
25 CFU/20 cm²
50 CFU/20 cm²

Category 3:
50 CFU/20 cm²

Category 4:
50 CFU/20 cm²

Method
- Replicate organism direct area contact (RODAC) plate
- Plate pressed for 10 seconds onto the surface
- Size of area sampled: 25 cm²
- Incubation: 35±1^oC, 18-24 hours, followed by room temperature, 18-24 hours
- Visual colony count
- Unit of measurement: colony forming unit (CFU)

Time between the index test and reference test

Simultaneously

Distance between sampling site for index test and reference test

Adjacent

Incomplete outcome data

N=0 (0%)

Reasons for incomplete outcome data

Not applicable

Percentage of failures*

ATP bioluminescence:

116/537 (21.6%; 95% CI: 18.3%-25.3%)

Microbiological culture:

39/537 (7.3%; 95% CI: 5.4%-9.8%)

Sensitivity
Category 1:
28.6% (95% CI: 5.4%-57.6%)

Category 2:
75.0% (95% CI: 22.6%-98.7%)

Category 3:
0.0% (95% CI: 0.0%-63.6%)

Category 4:
48.0% (95% CI: 29.1%-67.3%)

Specificity
Category 1:
97.1% (95% CI: 95.5%-99.1%)

Category 2:
92.5% (95% CI: 91.0%-93.1%)

Category 3:
94.0% (95% CI: 94.0%-96.9%)

Category 4:
55.7% (95% CI: 3.2%-58.4%)

The authors conclude that the ATP bioluminescence method is suitable and sensitive enough to be used in pharmacy cleanrooms as supplementary method, but that traditional microbiology remains the golden standard.

Procedure for random selection of surface levels not reported. Considering adjacent sampling this is unlikely to have introduced bias.

No standardisation of contamination level. This may have resulted in reduced precision (difference in contamination level between adjacent surface areas).

Dependent on the required cleanliness of surfaces, thresholds for cleanliness differed for the index test and the reference test. This limits comparability of observed sensitivities and specificities for different surface categories.

Blinding of outcome assessment not reported for reference test.

No incomplete data reported. It is considered unlikely that there were none.

Ziegler (2022)

Type of study

Multicenter, cluster-randomised controlled trial with pre-intervention baseline cohort.

Setting and country
Intensive care unit (ICU), hospital, United States

Funding and conflicts of interest
- Unrestricted grants from CDC Centers for Disease Control and Prevention (Centers for Disease Control and Prevention) Epicenters for the Prevention of Healthcare Associated Infections, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health.

- Payed consultancy for company not manufacturing ATP bioluminescence or UV/F marker devices.

- Receipt of equipment, ma- terials, drugs, medical writing, gifts, or other services from ATP biolumi- nescence and UV/F marker company

Inclusion criteria

Not reported

Exclusion criteria

Not reported

N total ICUs at baseline

ATP - UV/F: n=4
UV/F - ATP: n=2

Important prognostic factors

Not applicable (cross-over study)

Daily and terminal cleaning
- Quaternary ammonium compound
- Bleach in case of Clostridioides difficile

Monitoring of cleaning performance with adenosine triphosphate (ATP) bioluminescence assay

- Weekly
- High-touch surfaces
- At least five rooms
- After terminal cleaning
- Day, evening or weekend shift
- Hygiena SystemSURE Plus^TM (Hygiene, United States)
- Pass/fail cut-off: 25 RLUs
- Feedback of results

 Number of surfaces per month per ICU:
Mean 453*

Standard deviation 128

Range 83-801

*ATP vs. UV/F: p=0.002

Comparison 1 – UV/F

Monitoring of cleaning performance with ultraviolet light inspection of fluorescent marker (UV/F) (= randomised)

- Weekly
- High-touch surfaces
- At least five rooms
- After terminal cleaning
- Day, evening or weekend shift
- Glo-Germ Gel^TM (Ecolab)
- 1 cm diameter
- Feedback of results

 Number of surfaces per month per ICU:

Mean 353*

Standard deviation 120

Range 83-658

*ATP vs. UV/F: p=0.002

Comparison 2 – VI
(= baseline)
(= before-after)

Monitoring of cleaning performance with visual inspection

- 10-30% of patient rooms
- After terminal cleaning
- No feedback of results

Length of follow-up

Both intervention periods: 6 months

Washout: 2 months

Loss-to-follow-up:

None reported

Incomplete outcome data:

None reported

Hospital-acquired infection or colonisation with MDRO) (primary outcome)

ATP vs. VI:

IRR 0.89 (95% CI: 0.81-0.97) in favour of ATP

UV/F vs. VI:

IRR 1.10 (95% CI: 0.96-1.27) in favour of VI

ATP vs. UV/F:

IRR 0.88 (95% CI: 0.81-0.95) in favour of ATP

Hospital-acquired infection with MDRO alone

ATP vs. VI:

IRR 0.92 (95% CI: 0.85-0.998) on favour of ATP

UV/F vs. VI:

IRR 1.02 (95% CI: 0.74-1.42) in favour of VI

ATP vs. UV/F:

IRR 0.93 (95% CI: 0.69-1.25) in favour of ATP

The authors conclude that intensive monitoring of ICU terminal room cleaning with an ATP bioluminescence assay is associated with a reduction of MDRO colonisation and infection.

Open-label

Power calculation: minimum detectable difference: 30%

Number of surfaces monitored significantly higher for ATP period. Unclear whether this also pertains to feedback. Might have strengthened the effect of ATP.

Comparison 2 is the comparison of interest for the clinical question of the current review. This concerns an uncontrolled before-after comparison without interrupted time series analysis.

Concurrent changes in patient population or infection control practices not reported.

Feedback of results was only performed for ATP and UV/F, not for VI.

Trial not registered

Potential conflict of interest