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High throughput Lyophilised COVID-19 RT-qPCR Kit

C: Further assessment

This CE marked kit is a fully lyophilised RT-qPCR test for high throughput COVID-19 testing. All the reagents required for RT-qPCR are pre-dispensed into 8 well strips or 96 well plates and all the end user needs to do is add viral RNA.

This single reaction, single step RT-qPCR multiplex reaction detects the ORF1ab and N gene along side an internal control. 

The kit has been stabilised so it can be shipped and stored at ambient temperatures.

Key features:

  • All-in-One test: the lyophilized PCR reaction mixture contains all RT-qPCR components, pre-dispensed into 8 well strips 
  • The end user is only required to add RNA sample - simple and quick 
  • No need to dispense master mix components, eliminating errors and speeding up the process
  • Can be used with samples from upper respiratory tract specimens: Sputum, endotracheal aspirate, bronchoalveolar lavage, a nasopharyngeal aspirate or combined nasopharyngeal and oropharyngeal swabs 
  • CE/ IVD certified 
  • Identification of two genes: Orf1ab and N 
  • Validated for a wide range of Real-time PCR machines (including ABI7500, Quantstudio, Biorad CFX, Rotorgene, Roche Lightcycler, Agilent) 
  • Test sensitivity ≥ 10 RNA copies 
  • Storage and transport from +2 to +40°C 
  • The hydrated positive control is stable for 6 freeze thaw cycles 
  • Test time ~ 60 min 
  • Expiry date: 2 years 
  • No cross-reactivity to other microorganisms and respiratory viruses 
  • Sensitivity: > 99%, Specificity: > 99% 

   

Have you validated this method, if so, how and what were the results of the validation?

Limitations of the test
• Although this assay can be used with other types of samples it has been validated only with RNA extracted from respiratory samples (nasopharyngeal swab and oropharyngeal swab).
• Extremely low levels of target below the limit of detection might be detected, but results may not be reproducible.

Quality control
The kit contains a positive and a negative control that must be
included in each run to correctly interpret the results. Also, there is an internal control (IC) in each well which confirms the correct performance of the assay.

 

Performance characteristics
Sensitivity: > 99%
Specificity: > 99%


Test sensitivity
The kit has a detection limit of ≥10 RNA copies per reaction for
ORF1ab and N genes.
Dilution series of ORF1ab and N gene (10^7-10^1 copies/rxn) template run on the Bio-Rad CFX96™ Real-Time PCR Detection System (FAM & ROX channel).

Analytical specificity

The assay was confirmed by testing a panel consisting of different
microorganisms representing the most common respiratory pathogens. No cross-reactivity was detected between any of the following microorganisms tested.

Bordetella pertussis

Streptococcus pneumoniae Z022

Influenza A/Anhui/1/2013 (H7N9) virus

Bordetella parapertussis

Staphylococcus aureus subsp. aureus

Influenza B/Brisbane/60/2008 virus

Bordetella holmesii

Moraxella catarrhalis

Influenza B/Florida/04/06 virus

Bordetella bronchiseptica

Mycobacterium tuberculosis not rifampin resistant

Influenza B/Phuket/3073/2013 virus

Haemophilus influenzae MinnA

Pneumocytis jirovecii

Human parainfluenza 1, 2, 3 and 4 viruses

Chlamydia caviae

Influenza A/New Caledonia/20/99(H1N1) virus

Human metapneumovirus A and B

Chlamydia psittaci genotypes A and C

Influenza A/California/7/2009(H1N1) virus

Human rhinovirus type C
Chlamydophila pneumoniae CM-1

Influenza A/Michigian/45/2015 (H1N1)pdm09 virus

Human Adenovirus Types 1-5, 8, 15, 31, 40 and 41

Legionella bozemanii

Influenza A/Singapore/GP1908/2015 (H1N1)pdm09 virus

Human Bocavirus

Legionella micdadei

Influenza A/Perth/16/2009(H3N2) virus

Respiratory Syncytial virus (RSV) A and B
Legionella dumoffii

Influenza A/Thüringen/5/2017 (H3N2) virus

Human coronavirus 229E, OC43, NL63 and HKU1

Legionella pneumophila

Influenza A/Switzerland/9715293/2013 (H3N2) virus

MERS Coronavirus

Legionella longbeache

Influenza A/Hong Kong/4801/2014(H3N2) virus

SARS Coronavirus Strain Frankfurt 1

Mycoplasma pneumoniae

Influenza A/DE-SH/Reiherente/AR8444/ 2016 (H5N8) virus

Analytical reactivity
The reactivity was evaluated against RNA from Human 2019-nCoV strain BetaCoV/Germany/BavPat1/2020 p.1 showing positive results.

 

How quickly could this be deployed and what are the dependencies?

The low profile 8 well strip kit is available now and can be deployed immediately. 

There are currently 50,000 tests in stock. 

What is the likely production volume?​

50,000 tests a week.

What are the risks and barriers to using this at scale?

The supply chain is established and robust. The main limitation is the availability of the 96 well plate. The 8 well strip supply is fine. 

Who are you already partnering with on this?

Number of users in the EU including the prestigious French Pasteur Institute (The National Reference Center for Respiratory Infections). They performed an independent evaluation and within the report stated impressive results. 

 

Tagged users
Harry Singh

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Bev Matthews 4 months ago

Hello, you idea has been assessed and the champions has asked for a colleague to support with a more detailed review . We will be back in contact with you shortly. Many thanks Bev

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Bev Matthews 4 months ago

Status label added: C: Further assessment

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Harry Singh 4 months ago

Thanks Bev, I look forward to hearing from your colleague and welcome a more detailed review. I really think this kit can make a significant impact on laboratory workflows in the battle against COVID-19.

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