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Study Title: Virucidal Efficacy of a Test Substance For Use on Inanimate, Nonporous Surfaces
Product Identity: Bioneat (BIO-1001)Test Microorganism: Human coronavirus, Strain 229E, ATCC VR-740Study Identification Number: NG15491
Author: Emily Cox, B.S.Study
Completion Date: 05AUG2020Testing Facility: Microchem Laboratory 1304 W. Industrial Blvd. Round Rock, Texas 78681
Study Sponsor: United Food Products Jeff Kaufman 11555 Heron Bay Blvd., Ste 200 Parkland, FL 33076
STUDY REPORT SUMMARY
General Study Information
ASTM E1053 Method Virucidal Efficacy of a Test Substance For Use on Inanimate, Nonporous Surfaces
Study Identification Number:
Test System Test Microorganism:
Human coronavirus, Strain 229E, ATCC VR-740
Test Substance Receipt Date:
Test Parameters Test Substance Dilution:
Ready to use liquid test substance
Test Substance Application:
2.0 ml delivered by serological pipette
Organic Soil Load:
No additional soil load incorporated into the inoculum
Number of Replicates Per Lot:
Ambient room temperature (23.4 – 23.5°C) and 42% Relative Humidity (RH)
Sephadex LH-20 gel filtration columns
Study Dates Experimental Start Date/Time:
17JUL2020 / 1135
Experimental Termination Date/Time:
24JUL2020 / 1545
Study Completion Date:
The following measures are met to ensure the acceptability of virucidal efficacy data:
The product performance criteria follows:
The TCID50 (Tissue Culture Infectivity Dose) represents the endpoint dilution where 50% of the cell cultures exhibit cytopathic effects due to infection by the test virus. The endpoint dilution at which 50% of the host cell monolayers exhibit cytotoxicity is termed the Tissue Culture Dose (TCD50). The TCID50, and TCD50 was determined using the SpearmanKärber method and calculated as follows:
Negative logarithm of endpoint titer =
– Log of first dilution inoculated] – [((sum of % mortality at each dilution/100) – 0.5) x Logarithm of dilution]
The result of this calculation is expressed as TCID50/0.1 ml (or volume of dilution inoculated) for the test, virus control, and neutralization control and TCD50/0.1 ml (or volume of dilution inoculated) for the cytotoxicity control.
Calculation of the Log Reduction
The log reduction in viral titer was calculated as follows:
Plate Recovery Control Log10 TCID50 – Virus-Test Substance Log10 TCID50
Calculation of the Percent Reduction
The percent reduction in viral titer was calculated as follows:
Percent Reduction = 1- (C/B) x 100, where:
B = Average TCID50 of virus in control suspensions.
C = Average TCID50 of virus in virus-test suspensions.
The presence of any test substance cytotoxicity were taken into account when calculating the log and percent reductions in viral titer.
If multiple virus control and test replicates were performed, the average TCID50 of each parameter was calculated and the average result used to calculate the log reductions in viral titer.
The purpose of the study was to determine the virucidal efficacy of Bioneat (BIO-1001) against Human coronavirus Strain 229E, with no additional soil load incorporated into the inoculum, at a contact time of 10 minutes, and at an exposure temperature of room temperature (23.4 – 23.5°C) and 42% RH.
The Plate Recovery Control demonstrated an average viral titer of 4.80 Log10 TCID50 per carrier.
Test Substance cytotoxicity was detected in the lot of test substance assayed at 1.50 Log10.
The Test Substance Neutralization Control demonstrated that the test substance was neutralized at 1.50 Log10 for the lot assayed.
Taking the cytotoxicity and neutralization control results into consideration, the evaluated test substance, Bioneat (BIO-1001), demonstrated an average ≥3.00 Log10 reduction in viral titer (≥99.90%) at a contact time of 10 minutes.