COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2960

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Microplate, Strip

Specimen

Other biological fluids, Sputum, Throat secretion

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

The Vivid COVID-19 LAMP Direct-G diagnostic kit is an internally developed LAMP test for the detection of SARS-CoV-2 virus suitable for visual detection of the presence of SARS-CoV-2 RNA. The assay is one-step, i.e., involves RT and LAMP amplification in one reaction (RT-LAMP). In addition, this assay is designed to work with only minimally processed gargle samples with no prior RNA extraction required; samples only have to be heated/incubated with the provided inactivation reagent as per instructions before setting up the reaction. The kit contains a set of primers for the multiplexed detection of SARS-CoV-2 E, ORF1ab and N genes. This primer mix was specifically designed and optimized so that primer interactions do not lead to non-specific amplification products and thus to false positive results that are relatively common to the LAMP method. At the same time, multiplexed LAMP detection significantly increases the sensitivity and reduces the variation in detection time. The second set of primers is intended for the detection of the human RNase P gene, which serves as an internal control to verify correct patient material sampling, sample processing, RNA integrity, and test execution. While sequence-wise this primer set does not distinguish between genomic DNA and messenger RNA it does show significantly increased sensitivity towards RNA substrates in practice. The complete genomic RNA of the SARS-CoV-2 virus enriched with human RNA provided by the Biomedical Center of the Slovak Academy of Sciences is included as an internal positive control. For testing, two dry block heaters capable of heating samples to at least 95 °C are sufficient. In addition, the kit contains a patented proprietary colorimetric detection system, which is not sensitive to the pH of the input sample. With this system positive samples show a reliable color change from magenta to yellow which is easily visible by the naked eye.

Assay Type

Nucleic acid-Other

Self Test

N.A.

Reader Required

No

Subcategory

N.A.

Method

LAMP

Measurement

Qualitative

Time

40 minutes

LOD

1000 cpm

Positive control

RNA isolated from cell cultured SARS-CoV-2

Negative control

PCR water

Analytical Sensitivity

95 %

Analytical Specificity

100 %

Clinical Sensitivity

92.1 %

Clinical Specificity

100 %

Throughput

96 samples/run