Trial Outcomes & Findings for Clinical Validation of the Point-of-Care MSD Influenza Test (NCT NCT00863343)

Results Overview

A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.

Recruitment status

TERMINATED

Target enrollment

391 participants

Primary outcome timeframe

1 day

Results posted on

2012-03-01

Participant Flow

391 participants were selected from multiple U.S.Primary Care sites and exhibited influenza-like illness

no participants were excluded

Participant milestones

Participant milestones
Measure	Participants w/ Disease Positive for Flu A by reference test	Participants w/o Disease Participants without Flu A by reference method
Overall Study STARTED	17	374
Overall Study COMPLETED	17	374
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Validation of the Point-of-Care MSD Influenza Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants w/ Disease n=17 Participants Positive for Flu A by reference test	Participants w/o Disease n=374 Participants Participants without Flu A by reference method	Total n=391 Participants Total of all reporting groups
Age, Customized Between 0 and 100 years	17 participants n=5 Participants	374 participants n=7 Participants	391 participants n=5 Participants
Sex/Gender, Customized Female	NA participants n=5 Participants	NA participants n=7 Participants	—
Sex/Gender, Customized Male	NA participants n=5 Participants	NA participants n=7 Participants	—
Sex/Gender, Customized Result Totals	17 participants n=5 Participants	374 participants n=7 Participants	391 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: per protocol

A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.

Outcome measures

Outcome measures
Measure	Participants w/ Disease n=17 Participants Positive for Flu A by reference test	Participants w/o Disease n=374 Participants Participants without Flu A by reference method
MSD Influenza A Test Results Against Cell Culture Flu A Positive by MSD test	14 participants	5 participants
MSD Influenza A Test Results Against Cell Culture Flu A Negative by MSD test	3 participants	369 participants

PRIMARY outcome

Timeframe: 1 day

A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

Outcome measures

Outcome measures
Measure	Participants w/ Disease n=27 Participants Positive for Flu A by reference test	Participants w/o Disease n=364 Participants Participants without Flu A by reference method
MSD Influenza B Test Results Against Cell Culture Flu B Positive by MSD Test	22 participants	1 participants
MSD Influenza B Test Results Against Cell Culture Flu B Negative by MSD Test	5 participants	363 participants

PRIMARY outcome

Timeframe: 1 day

A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

Outcome measures

Outcome measures
Measure	Participants w/ Disease n=25 Participants Positive for Flu A by reference test	Participants w/o Disease n=370 Participants Participants without Flu A by reference method
MSD Influenza A Test Results Against Culture and PCR Flu A Positive by MSD Test	22 participants	1 participants
MSD Influenza A Test Results Against Culture and PCR Flu A Negative by MSD Test	3 participants	369 participants

PRIMARY outcome

Timeframe: 1 day

A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

Outcome measures

Outcome measures
Measure	Participants w/ Disease n=28 Participants Positive for Flu A by reference test	Participants w/o Disease n=367 Participants Participants without Flu A by reference method
MSD Influenza B Test Results Against Culture and PCR Flu B Positive by MSD Test	22 participants	1 participants
MSD Influenza B Test Results Against Culture and PCR Flu B Negative by MSD Test	6 participants	366 participants

Adverse Events

Participants With Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants w/o Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dennis Mertz, Director Regulatory and Clinical Affairs

Meso Scale Diagnostics, LLC.

Phone: 240 631-2522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60