Efficacy of a Multiplex BangasureTM RT-PCR Kit for the Detection of COVID-19

NCT05190016 | Completed DMC

• 1 other identifier: BANGASURE RT-PCR Kit
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The outbreak of the severe acute respiratory syndrome (SARS) corona virus (CoV)-2 continues to increase globally. To control the coronavirus disease 2019 (COVID-19) transmission, diagnose is very important step which would help in the process of quarantine, isolation of the infected person and also in contact tracing. Among the various techniques real-time reverse transcription polymerase chain reaction (rRT-PCR) is mostly used and considers as gold standard method for viral nucleic acid detection as per World Health Organization (WHO) and Centre for Diseases Control (CDC), USA. However, possible false-negative and false-positive results produce misleading consequences, making it necessary to improve existing methods. So, investigators need a robust and reliable PCR kit to detect different kinds of variant of SARS-CoV-2 virus to reduce its transmissibility and take preventive management plan. Beside that to manage the increasing number of testing, investigators are mostly dependent on imported test kit which seems to be very difficult at this pandemic situation and costly. Hence, virulence of SARS-CoV-2 virus may change rapidly due to mutation and country become hot spot so, gene detection RT-PCR kit is time demand. In this point of view, investigator's aim to develop an validate multiplex rRT-PCR qualitative diagnostic method, which targets two viral genes E (envelope protein), N (nucleocapsid gene, according to the CDC, USA guidelines for the development of RT-PCR kit and one human gene RNase P as internal control simultaneously. This is a case control study where will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). This specimen will be blinded before supplying over to NILMRC/Contact ROL/ Bangladesh Clinical Trail Limited (BCTL), Dhaka, Bangladesh for Bangladesh Reference Institute for Chemical Measurements (BRiCM) RT-PCR Kit. Required in house validation will also be conducted as per International Council for Harmonization (ICH) and FDA guideline and also external validation will be carried in different Director General of Health Service (DGHS), Bangladesh approved COVID-19 diagnostic laboratory. Data will be analyzed by computer using Statistical Package for the Social Sciences (SPSS) software and will be presented into the frequency table, graph and chart according to the requirements.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Performance evaluation of BRiCM COVID-19 RT-PCR

  Determine Performance evaluation of BRiCM COVID-19 RT-PCR with extracted viral RNA by using standard viral RNA extraction kit for the detection of SARS-CoV-2 virus in nasopharyngeal swab specimens collected in the nationwide COVID-19 screening program. RNA extraction from fresh Nasopharyngeal Swab sample in the Viral Transport Medium (VTM) of COVID-19 patients from IEDCR (30 positive and 30 negative) Analysis of COVID-19 RNA samples using RT-PCR.

  1 month

Secondary Outcomes (1)

• Reduce the price and enhance the efficiency to detect COVID-19 by BRiCM COVID-19 RT-PCR kit

  1 month

Study Arms (4)

Cases (Current/fresh)

Cases (current/fresh) are defined as those samples which has been tested positive by RT-PCR at IEDCR as a regular screening program and have not been stored in the freezer.

Cases(stored)

Cases (stored) are defined as those samples which has been tested positive by RT-PCR at IEDCR as a regular screening program and have been stored in the -80°C freezer at IEDCR.

Control (Current/fresh)

Control (Current/fresh) are defined as those samples which has been tested negative by RT-PCR at IEDCR as a regular screening program and have not been stored in the freezer.

Control (stored)

Control (stored) are defined as those samples which has been tested negative by RT-PCR at IEDCR as a regular screening program and have been stored in the -80°C freezer at IEDCR

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IEDCR and BCTL/CROL as CRO have MoU for different collaborative research work. So, NILMRC/ BCTL/CROL will receive a total 120 sample from IEDCR for the evaluation of RT-PCR kit efficiency. Of the 120 samples, 60 will be stored samples (30 COVID-19 known positive and 30 COVID19 negative samples) which have been kept at -80°C lab freezers at IEDCR facilities and another 60 fresh specimens (30 COVID-19 positive and 30 COVID19 negative samples) which are being tested at IEDCR. Samples with discordant results will be rejected before testing by BRiCM RT PCR kit. That is, more than 120 identified samples from IEDCR might be needed to analyze by imported RT-PCR kits and extraction kit at BCTL/CROL. This is how 120 samples will be selected for performance evaluation of BRiCM RT-PCR kit.

You may qualify if:

• Samples with Positives RT-PCR results with Ct value≤35 for the COVID-19 genes at IEDCR will be selected as COVID-19 positive.
• Samples with negative RT-PCR results with no amplification for the COVID-19 genes at IEDCR will be selected as COVID-19.

You may not qualify if:

• Samples with equivocal/ambiguous RT-PCR results in terms of sigmoidal curve and Ct value will be excluded.

Sponsors & Collaborators

• DR. MALA KHAN: lead

Study Sites (1)

Institute for Developing Science and Health Initiatives

Dhaka, 1212, Bangladesh

Location

Related Publications (14)

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MAMUDUL HASAN RAZU, MSc

  Scientific Officer

  PRINCIPAL INVESTIGATOR

• MD MONIRUZZAMAN, BSc

  Senior Scientific Officer

  STUDY CHAIR

• PRANAB KARMAKER, Dr

  Senior Scientific Officer

  STUDY CHAIR

• ZABED BIN AHMED, MSc

  Senior Scientific Officer

  STUDY CHAIR

• MD IQBAL HOSSAIN, MSc

  Scientific Officer

  STUDY CHAIR

• MD FAZLE ALAM RABBI, Dr

  Lecturer

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director General

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 13, 2022
• Study Start: June 1, 2022
• Primary Completion: August 20, 2022
• Study Completion: September 15, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)