Validation of Reduced Incubation Times (Readout ReliabilityData)
The 3‑hour and 48‑hour incubation times have been correlated with a 7‑day incubation period. Sterilized indicators were examined daily for detection of a visual pH color change. The
3‑hour fluorescence change reading and the 48‑hour visual pH color change reading were compared to the 7‑day visual pH color change readings to determine the readout reliability of
the indicator. Readout reliability of the Attest™ 1292rapid readout biological indicator was determined using the sensitivity calculation describedbelow:
Sensitivity = (Number of Growth Positives after 168hours) – (Number of FalseNegatives) X100
Number of Growth Positives after 168Hours
Attest™ 1292Rapid Readout BiologicalIndicators 121°C (250°F) Gravity Displacement and 132°C (270°F) VacuumAssisted Steam SterilizationProcesses Validation of Reduced Incubation Time ‑ Readout ReliabilitySummary
Sterilization
Process
Incubation
Temperature
#
Tested
# Growth
Positives at
168hours
Growth Fluorescence
# False
Negatives at
48hours
Sensitivity
at 48hours
# False
Negatives at
3hours
Sensitivity
at 3hours
121°C (250°F)
Gravity
Displacement
60°C (140°F) 1620 800 599.4 0100
132°C (270°F)
Vacuum
Assisted
60°C (140°F) 1270 654 299.7 0100
These data demonstrate that ≥ 97% of the 7‑day (i.e. 168hours) growth visual positives were detected by fluorescence within 3hours of incubation and by the visual pH color within
48hours of incubation. The 3M™Attest™ 1292Rapid Readout Biological Indicator therefore meets readout reliability of ≥ 97% for the 3hour fluorescence results and the 48hour
visual color changeresults.
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