Africa Suitcaselab Project

2020 by Universitat Leipzig

Africa Suitcaselab is a project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and an African-European partnership for development and deployment of rapid SARS-CoV-2 RNA and antigen detection assays by the Botnar Research Centre for Child Health (BRCCH). Both contain a multi-country blinded phase 2 study to evaluate rapid detection systems of SARS-COV-2.

The Project

Our main aim is to evaluate 3 different point of need systems (isothermal amplification, peakPCR and rapid antigen test) for SARS-COV-2 through a multi-country blinded study and its implementation in low resource settings. Learn more about our projects.

The consortium consists of 3 European Partners (coordination and assay development) as well as 7 North and Sub-Saharan partners (diagnostic evaluation). Learn more about who we are.

The Project

  1. Diagnostic accuracy determination of point of need assays 
    Determining the diagnostic accuracy of point of need assays (isothermal amplification, peakPCR and rapid antigen test).
  2. International collaboration
    Building cross border collaboration involving 9 countries from Europe, North and Sub-Saharan Africa.

  3. Capacity building 
    Building capacity for safe handling of BSL-3 pathogens using the glove box.

  4. Suitcase lab implementation
    Implementation of the suitcase lab for rapid detection of SARS-COV-2.

Expected Impact

COVID-19 has emerged as a new viral disease in late 2019 and has rapidly spread and developed into a global pandemic with severe health and economic impact. Although real-time RT-PCR is currently used as the standard method for SARS-COV-2 molecular diagnosis, it requires a well-established laboratory, specifically trained personnel, is time-consuming (2-5 hours) and thus involves high costs altogether. Therefore, the need of other rapid and simple diagnostic approaches maintaining the high performance of RT-PCR is of utmost urgency.

 
 

peakPCR

In the past 3 years, Prof. Stark´s at the Swiss Federal Institute of Technology, Switzerland (ETH) working group has designed and constructed a completely new PCR instrument (called “peakPCR”) with a proprietary metallic sample holder, built with inexpensive and easily available components and therefore at an extremely competitive price (Figure 1). Thanks to the low reaction volume required by the sample holder, the PCR amplification can be performed faster and generate significant reagents savings.

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The Team

This project is funded by the EDCTP and the BRCCH. This project is a collaboration between partners in Ghana, Senegal, Madagascar, Nigeria, DR Congo, Sudan and Uganda, where the field activities will take place, and partners in Germany, France and Switzerland involved with development and refinement of the SARS-COV-2 rapid diagnostic tests.

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Covid Variants

diaxxoPod (RUO)

Description

Our in-vitro diagnostic test cartridge based on rapid Polymerase Chain Reaction (PCR) amplification technology. This cartridge can reliably detect and distinguish the mutants from UK (20I/501Y.V1, B.1.1.7 – VOC-202012/01) as well as the South African mutation (B.1.351 lineage).

The test cartridge is aimed to improve the public health situation by rapidly enabling the detection of variants of concern. The cartridge is designed for qualitative detection of variants of interest of the SARS-CoV-2 Viral RNA in saliva samples and it works in conjuction with diaxxoPCR.

Specs

  • Fully preloaded and only require addition of purified sample
  • Results in approx. 30 minutes

Workflow

The test cartridges are sold with all the necessary reagents pre-loaded in the reaction wells. The use of the test cartridges is therefore extremely simple:

  • Apply the sample (viral RNA)
  • Apply water in the control wells and the cover fluid
  • Insert the cartrdige in diaxxoPCR, press a button, drink a coffee and check your results.

Notes & Instructions

  • The cartridges are supplied in a vacuum-sealed bag in order to ensure a long shelf life at room temperature.
  • Detailed instructions about how to use the cartridges and the devices are provided

SARS-CoV-2

diaxxoPod

Description

This SARS-CoV-2 cartridge is based on the US Centers for Disease Control and Prevention (CDC) RT-PCR test for 2019-nCoV. The assay detects 2 parts of the N gene specific for Sars-CoV-2. In addition, an extraction control for Human RNAse P is also included. The cartridge is designed to work in combination with saliva samples and in conjuction with our diaxxoPCR.

Specs

  • Functionally validated and confirmed template-free to cycle 45 by NTC testing
  •  Fully preloaded and only require addition of purified DNA/RNA
  • Results within 30 minutes

Workflow

The test cartridges are sold with all the necessary reagents pre-loaded in the reaction wells. The use of the test cartridges is therefore extremely simple:

  • Apply the sample (viral RNA)
  • Apply water in the control wells and the cover fluid
  • Insert the cartrdige in diaxxoPCR, press a button, drink a coffee and check your results.

Notes & Instructions

  • The cartridges are supplied in a vacuum-sealed bag in order to ensure a long shelf life at room temperature.
  • Detailed instructions about how to use the cartridges and the devices are provided

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