COVID-19 qPCR Multi Kit (1copy™ )
Interpretation of Results
Specimen Collection, Storage and Preparation
Materials Required but Not Provided etc...
1copy™ COVID-19 qPCR Multi Kit provides the fast and accurate testing solution for SARS-CoV-2, specifically targeting the E gene for beta coronavirus and the RdRp gene for SARS-CoV-2 in nasopharyngeal swab and oropharyngeal swab.
Our COVID-19 Real-Time PCR assay is based on the WHO & CDC reference method and it has been carried out the in silico analysis for all registered SARS-CoV-2 sequence database.
2. Intended Use
1copy™ COVID-19 qPCR Multi Kit is a real-time RT-PCR test intended for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swab, midturbinate nasal swab and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests or by similarly qualified non U.S. laboratories.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab, mid-turbinate nasal swab and oropharyngeal swab 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.
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 1copy™ COVID-19 qPCR Multi Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Testing of nasal and mid-turbinate nasal swabs (self-collected or collected by a healthcare provider) is limited to patients with symptoms of COVID-19. Please refer to FDA’s FAQs on Diagnostic Testing for SARS-CoV-2 for additional information.
3. Materials Provided
|Kit contents||Cap color||Volume|
|Master mix||Red||2 x 1000 ㎕|
|Primer/Probe mix 1(E gene)||Brown (Amber tube)||100 ㎕|
|Primer/Probe mix 2(RdRp gene)||Brown (Amber tube)||100 ㎕|
|Control 1 (E gene)||Yellow||100 ㎕|
|Control 2 (RdRp gene)||Yellow||100 ㎕|
|DEPC DW||Clear||1000 ㎕|
Control 1 for E gene and Control 2 for RdRp gene are positive controls.
DEPC DW is used as a negative control.
4. Materials Required but Not Provided
RNase/DNase free consumables (disposable latex or vinyl gloves)
0.5㎖ or 0.2㎖ PCR tubes or 96-well PCR plates compatible with instrument manufacturer’s instructions
1.5㎖ micro tubes
Ice or cooling/cold block
Microliter pipettes (1~10㎕, 10~100㎕, 100~1000㎕)
Mini centrifuge (0.2㎖/0.5㎖ tubes, 10,000 rpm) or Benchtop centrifuge with rotor for 0.2㎖/0.5㎖ reaction tubes (capable of attaining 10,000 rpm), vortexer
Sample collection and sample preservation buffer (Puritan UniTranz-RT 3ml Filled Vial w/ Elongated & Ultrafine Flock Swabs (Cat No. UT-367))
Real-time PCR instrument
Reagents or kit for RNA extraction.
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