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IVD Testing (COVID-19)

LamPORE 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 smaller, local environments — addressing the need for rapid, routine testing of large numbers of people.

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. Register your interest to be kept informed.

Benefits

Advantages of LamPORE COVID-19

Real-time

Rapid & scalable

Flexible, on-demand processing of 24–480 samples per run; over 9,000 samples in 24 hours

High specificity

Sensitive & specific

99.1% sensitivity; 99.6% specificity

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Cost-efficient

Consumable purchase only with minimal training, equipment, or hands-on time required

Accurate icon

Accurate

Targets three highly conserved SARS-CoV-2 genes, reducing inconclusive results and requirement for repeat testing

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Reliable

Distinguish between poorly collected samples and true negatives using inbuilt control

Workflow

Complete, end-to-end workflow

Automatable with optional LIMS integration.

Nanopore Diagnostics sequencing device

The Lampore Assay

A complete, end-to-end assay

The fully integrated assay comprises a GridION Oxford Nanopore Diagnostics device — 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 (or up to 9,120 samples in 24 hours) 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.

Workflow

LamPORE workflow

The LamPORE COVID-19 assay is performed on extracted RNA from 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 Test Workflow
Figure 1: The fully integrated LamPORE COVID-19 workflow provides a simple, fast, and accurate method for detecting the presence of SARS-CoV-2 in a sample.

Specifications

Performance

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.

Performance characteristics

Sensitivity 99.1% (96.9 - 99.9)
Specificity 99.6% (98.0 - 100)
Reproducibility 96.6%
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
Weight 11 kg
On-board analysis Yes
LIMS compatible Yes
Scalable Run 1–5 flow cells independently (up to 96 samples per flow cell)
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Regulatory status

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. Register your interest to be kept informed.

Intended use

CE-IVD

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.

MinION Mk1C

In development

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
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Nanopore DX Products

SARS-CoV-2 research products

Discover how researchers are using nanopore sequencing to enhance our understanding of SARS-CoV-2 through:

  • Rapid whole genome sequencing
  • Direct RNA sequencing
  • Metagenomic sequencing
COVID-19 research