IVD Testing (COVID-19)
A rapid, low-cost, highly scalable diagnostic test for SARS-CoV-2
LamPORE COVID-19 is a molecular diagnostic assay for routine detection of SARS-CoV-2, the virus that causes COVID-19. The assay is highly scalable, allowing deployment in both high-throughput, traditional laboratory settings as well as smaller, local environments — addressing the need for rapid, routine testing of large numbers of people.
Advantages of LamPORE COVID-19
Rapid & scalable
Flexible, on-demand processing of 24–480 samples per run.
Sensitive & specific
99.1% sensitivity; 99.6% specificity
Consumable purchase only with minimal training, equipment, or hands-on time required
Targets three highly conserved SARS-CoV-2 genes, reducing inconclusive results and requirement for repeat testing
Distinguish between poorly collected samples and true negatives using inbuilt control
Complete, end-to-end workflow
Automatable with optional LIMS integration.
The Lampore Assay
A complete, end-to-end assay
The fully integrated assay comprises a— with built-in analysis software — and consumables, including flow cells and LamPORE COVID-19 kits. The locked-down workflow allows processing of up to 480 samples per run across up to five flow cells. Each flow cell can be addressed and run independently, offering highly flexible, demand-based testing.
LamPORE technology is highly versatile and a number of product line extensions are in development.
The LamPORE COVID-19 assay is performed onfrom oropharyngeal and nasopharyngeal swabs. The assay leverages reverse-transcription coupled to loop-mediated isothermal amplification (RT-LAMP) to amplify three highly conserved genes in SARS-CoV-2 positive samples (E gene, N gene, ORF1a) and a negative control gene (human actin).
Requiring a 35-minute incubation at 65ºC, isothermal amplification is a simple, fast, and robust method for amplifying a specific target, with no requirement for specialised equipment.
Following amplification, samples are prepared for analysis using Oxford Nanopore’s rapid sample preparation chemistry. During amplification and sample preparation, unique molecular barcodes are added to each individual sample, enabling large numbers of samples to be combined and analysed simultaneously.
The prepared samples are loaded onto the specially configured GridION device and real-time analysis begins. When sequencing reads aligning to the SARS-CoV-2 genome and control target reach a threshold number per sample, the sample can be classed as positive.
The built-in human actin control, which amplifies in all correctly collected samples, enables the discrimination of negative results due to sample collection errors and negative results due to the absence of SARS-CoV-2 infection.
Analysis is performed automatically by the GridION OND device with no requirement for manual intervention or interpretation. Results are provided in visual and LIMS-compatible report formats, with the status of each sample clearly identified.
LamPORE COVID-19 provides reliable and routine detection of SARS-CoV-2 from oropharyngeal and nasopharyngeal swabs. The assay targets three highly conserved regions of the SARS-CoV-2 genome (N gene; E gene; ORF1a), providing enhanced sensitivity and reducing inconclusive results and requirement for repeat testing.
|Sensitivity||99.1% (96.9 - 99.9)|
|Specificity||99.6% (98.0 - 100)|
|Limit of detection||7–10 genome copies/µl (equivalent to 140–200 virus copies per reaction)|
Refer to Instructions for Use document for more detailed performance characteristics.
GridION OND device specifications
|Size||W 370 mm, H 220 mm, D 365 mm|
|Scalable||Run 1–5 flow cells independently (up to 96 samples per flow cell)|
Product availability varies by country and is subject to local regulatory requirements.
LamPORE COVID-19 is CE marked for in vitro diagnostic use. The Company intends to file regulatory submissions for diagnostic usage of LamPORE COVID-19 in other countries and regions, including FDA-Emergency Use Authorisation in the US.
Oxford Nanopore Diagnostics LamPORE COVID-19 Test Kit 96 Plex (Small or Medium) is a test intended for qualitative detection of nucleic acid from the SARS-CoV-2 virus in oropharyngeal and nasopharyngeal swabs.
Positive results indicate the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Oxford Nanopore Diagnostics LamPORE COVID-19 Test Kit 96 Plex is intended for use by trained laboratory personnel experienced in the conduct of in vitro diagnostic procedures.
Documents & resources
The LamPORE methodology is highly versatile and a number of product line extensions for potential regulatory submission are in development, including:
- Multiplexing of 768 samples per flow cell
- RNA extracted from saliva
- Respiratory Panel virus detection, including influenza, respiratory syncytial virus (RSV), and SARS-CoV-2
- Portable analysis on the hand-held MinION Mk1C device
Identify and track SARS-CoV-2 variants with end-to-end whole genome sequencing workflows — discover how research devices from Oxford Nanopore Technologies are supporting COVID-19 outbreak management:
- Rapid results — from RNA to answer in as little as 9 hours
- Scalable — 12 to 2,304 samples in a single run
- Accessible — $1,000 for a MinION Starter Pack with 48-hour delivery, and capital-free high-throughput options
- Deployable — from portable, decentralised sequencing to high-throughput, automated workflows