Novel Assays for Detection of Influenza Virus

NCT03924284 | Withdrawn

• 1 other identifier: FluA_20190110
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans. Molecular assays are now used routinely in the detection of influenza viruses. The M gene is often used as the target for all influenza A viruses because the nucleotide sequence of this gene is relatively conserved among all the influenza A viruses. The World Health Organization and the US Centers for Disease Control and Prevention (CDC) have published protocols for molecular detection of influenza A virus M gene. However, recent studies have shown that mutations in the M gene have led to a reduced sensitivity of RT-PCR assay targeting this gene. Therefore, it is important to use alternative conserved genes as the target of RT-PCR. In this study, our aim is to evaluate two new RT-PCR assays that are based on PB2 and NS gene segment.

Conditions

Influenza A Virus

Outcome Measures

Primary Outcomes (1)

• RT-PCR result

  The result of RT-PCR can be positive or negative

  Through study completion, an average of 2 months

Secondary Outcomes (1)

• Cycle threshold value

  Through study completion, an average of 2 months

Study Arms (4)

NPA positive

NPA specimens that are tested positive for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong

Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR

NPA negative

NPA specimens that are tested negative for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong

Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR

Saliva positive

Saliva specimens that are tested positive for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong

Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR

Saliva negative

Saliva specimens that are tested negative for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong

Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR

Interventions

PB2 gene RT-PCR; NS gene RT-PCR DIAGNOSTIC_TEST

PB2 gene RT-PCR: RT-PCR targeting the PB2 gene of influenza A virus NS gene RT-PCR: RT-PCR targeting NS gene of influenza A virus

NPA negative; NPA positive; Saliva negative; Saliva positive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

These archived nasopharyngeal and saliva specimens are collected from patients in Queen Mary Hospital

You may qualify if:

• Nasopharyngeal or saliva specimens of patients in Queen Mary Hospital of Hong Kong
• Tested for influenza A virus using a commercially available assay or by the Public Health Laboratory Services Branch in Hong Kong

You may not qualify if:

• Insufficient specimen volume

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

The total nucleic acid will be stored.

Study Officials

• Kelvin To, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: April 23, 2019
• Study Start: April 18, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)