Device identification number

1153

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Target type

Nucleic acid

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The COVID-19 RT-PCR PNA KIT is developed for detection about TWO target region of SARS-CoV-2 that are N gene with FAM and RdRP gene with HEX, and also additionally detectable Human acidic protein gene with Cy5 for internal control. the KIT use not hydrolysis probe like TaqMan probe but Hybridization probe 'Peptide Nucleic Acid' which is kind of artificial Nucleic acid that have high stability about themal and does not cleave by indeed enzyme like polymerase, exo, endonuclease. It induce the advantage of the kit with no worry about false positive result. and cDNA synthesis and PCR are done in one tube and multi-targets can detect in one tube in just 3 steps that 1) Premix and primer&probe mixture Mixed up 2) dispense the sample and Positive, Negative control 3) Run the protocol in instrument. The kit also authorized by ISO13485 that quality control management and CE-IVD marked, also approved US FDA EUA. and ceritificate for free sale to export in KOREA. 344 RT-PCR-confirmed cases containing 55 positive and 289 negative specimens are tested. The data above are >14 days from symptom onset to blood collectionMade in Taiwan https://drive.google.com/file/d/1vJgzeTNjDYsYbbxzvo8N2rNj1vcRhJq6/view

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

140 minutes

LOD

2.5 copies/μl (RdRP gene)

LOD

3.7 copies/μl (N gene)

Positive control

artificially synthesized RNA of SARS-CoV-2 RdRP and N genes + short regions from the human acidic ribosomalprotein (HuPO) gene

Negative control

Nuclease Free water

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Throughput

96 samples/run

Notes

information provided by the manufacturer + website: SPECIMENS: nasopharyngeal swab samples. Possibly Oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal, wash/aspirates or nasal aspirates; CROSSREACTIVITY checked against: Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Adenovirus subtype B, Adenovirus subtype C, Human Metapneumovirus (hMPV), Human parainfluenza 1, Human parainfluenza 2, Human parainfluenza 3, Human parainfluenza 4, Influenza A, Influenza B, Human Respiratory syncytial virus A, Human Respiratory syncytial virus B, Rhinovirus A, Rhinovirus B, Bordetella pertussis, Mycoplasma pneumoniae; INTERNAL CONTROL: primer set and probe to detect a specific region of Human acidic ribosomal protein (HuPO) gene.