2019 Novel Coronavirus Detection Kit - COVID-19
Powered by Shimadzu's AmpdirectTM Technology
For In Vitro Diagnostic Use. Pending Emergency Use Authorization. For Prescription Use only.
Shimadzu adapted its AmpdirectTM *1 technology to meet today's most pressing need: SARS-Cov-2 testing. Viral / Universal Transport Medium samples from oropharyngeal and nasal swabs can be tested using a simple protocol which excludes RNA extraction.
Most PCR methods for SARS-CoV-2 RNA detection require labor intensive RNA extraction. Shimadzu's AmpdirectTM eliminates RNA extraction which simplifies the method, reducing sample preparation time, materials, and waste.
The 2019 Novel Coronavirus Detection Kit powered by AmpdirectTM technology was developed based on the pathogen detection standards of the Japanese National Institute for Infectious Diseases*3 which relied on extensive experience dealing with SARS-CoV and influenza outbreaks.
*1: Ampdirect is a trademark of Shimadzu Corporation
*2: Reaction time may vary depending on equipment used. Sample or reagent preparation times may increase when handling large numbers of samples.
*3: Japanese National Institute for Infectious Diseases, “Pathogen Detection Manual for 2019-nCoV”
*4 Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019-nCoV. https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html.
2019 Novel Coronavirus Detection Kit - Example Results
Detection of the N1 and N2 segments of the novel coronavirus (SARS-CoV-2) nucleocapsid (N) gene
Refer to the Instructions For Use for a more detailed explanation of the method and interpretation of results.
Quick and Simple Worklfow
The Shimadzu 2019 Novel Coronavirus Detection Kit includes reagents needed to test V/UTM for SARS-CoV-2 RNA by multiplexed RT-PCR. The three stage workflow, involves mixing VTM with Sample Treatment Reagent and heating (5 minutes); mixing three RT-PCR reaction solution components to scale; and distributing the reaction solution to the heat treated samples can be completed in approximately 1 hour. Thanks to AmpdirectTM technology, no RNA extraction is required! V/UTM samples are prepared simply by adding Sample Treatment Reagent and heating.
To prevent false negatives, the 2019 Novel Coronavirus Detection Kit uses a RNase P internal control to confirm integrity of the sample, sample preparation, and data collection.
Ampdirect Technology Works without RNA Extraction
PCR inhibition appears to be caused by positively-charged substances in the biological sample (some types of protein etc.), which are adsorbed to the DNA/RNA template, and some negatively-charged substances (some sugars, pigments etc.), which are adsorbed to the DNA polymerase. Ampdirect suppresses these substances, enabling direct RT-PCR of biological samples.
- Pending FDA Emergency Use Authorization (EUA). For in Vitro Diagnostic Use (IVD). This test has been authorized by FDA under an EUA for use by authorized CLIA laboratories or equivalents outside the US. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory and bronchoalveolar lavage (BAL) specimens during the acute phase of infection. Positive results are indicative of 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
- 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. Testing with the COVID-19 Detection Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic."procedures.