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Rapid (20 minute) desk top RT PCR analyser (VitaPCR) by Menarini Diagnostics

D3: Catalogue of Resources

Menarini Diagnostics has introduced a rapid molecular assay that identifies the target virus from patients infected with SARS-CoV-2  and can aid in the effective control of the global outbreak.  Weighing just 1 kg, this small compact unit is ideal to be deployed in POCT scenarios such as A&E, Critical Care, Clinics, Surgeries, Testing Pods, Drive Through Centers, etc.  The analyser has an integrated bar code reader to scan in each test reagent pack for further ease of use.  Positive and Negative control material is also available to quality control the analyser.

The VitaPCR SARS-CoV-2 assay performed on the VitaPCR instrument utilizes real time reverse transcription polymerase chain reaction (RT-PCR) amplification technology for the qualitative detection of Coronavirus Disease 2019 (COVID-19) viral RNA in nasopharyngeal (NP) or oropharyngeal (OP) swabs from patients with signs and symptoms of respiratory infection.  Results are for the presumptive identification of SARS-CoV-2.

The detection target of SARS-CoV-2 RNA is located in the region of the virus nucleocapsid (N) gene. The assay is designed for specific detection of the SARS-CoV-2 RNA. In addition, detection of SARS-like (including SARS-CoV-2, SARS-CoV, bat SARS-like coronavirus) conserved region also located in N gene is provided as additional information for reference. An additional primer/probe set to detect human Beta-globin (HBB), which is also used as a sample adequacy control (SAC), is included in the reagent for ensuring adequate addition of sample and monitoring the presence of inhibition factors in the PCR process.

LoD studies determine the lowest detectable concentration at which ≥ 95% (19/20) of the replicates were positive.  The in vitro transcribed full length of SARS-CoV-2 RNA (N gene) is used in the LoD determination study. This RNA transcript stock has a known titre (RNA copies/µL) spiked into the Sample Collection Buffer (SCB) consisting of negative clinical matrix to mimic a clinical specimen.  Samples were tested with the VitaPCR SARS-CoV-2 assay according to the instructions for use.

This data demonstrates that the VitaPCR SARS-CoV-2 assay detects 2.73 copies/μl of SARS-CoV-2 RNA transcripts with a confidence ≥95%. This concentration therefore serves as the limit of detection.

The analytical specificity (cross-reactivity) of the assay was also tested, with no cross reactivity observed from other viruses (Flu A+B, RSV, Adenovirus, other Coronaviruses).

Due to the difficulty of obtaining clinical specimens from SARS-CoV-2 infected patients, performance characteristics of the VitaPCR SARS-CoV-2 Assay has been evaluated using contrived clinical specimens. The in vitro transcribed full length of SARS-CoV-2 RNA (N gene) was used in this testing. This RNA transcript stock with known titre (RNA copies/µL) spiked at different concentrations was prepared for spiking 30 individual negative NP or OP swab specimens at different concentrations.

The samples were blinded, randomized and spiked into Sample Collection Buffer (4 ml) in which individual negative NP or OP swab specimens were eluted.  20 NP or OP swab specimens were spiked at 1.5x LoD, 5 at 3x LoD, and 5 at 5x LoD. Another 30 individual negative NP or OP swab specimens were left un-spiked.    All 60 samples were blinded, handed and randomized to unbiased operators to analyze with the VitaPCR SARS-CoV-2 Assay to generate the Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), and Overall Percentage Agreement (OPA) as a measurement of estimated Diagnostic Accuracy.  The overall agreement was 100% for both swab types.

The system is available now and can be deployed immediately into NHS and private settings.

edited on Jun 24, 2020 by Tom Jordan
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Bev Matthews 9 months ago

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Bev Matthews 9 months ago

Status label removed: D

Bev Matthews 8 months ago

Status label added: D

Status label removed: C

Bev Matthews 8 months ago

Status label added: D3

Bev Matthews 7 months ago

Status label removed: D: Ready to share