Specification: 50T/kit or 100T/kit vial; 48T/kit or 96T/kit 0.1mL 8 strips/0.2mL 8 strips.
Canine distemper virus(CDV) is caused by a single-stranded RNA virus of the family . The disease is highly contagious via inhalation. The distemper virus real time PCR detection kit is intended for the qualitative detection of Canine distemper virus in samples by using real time PCR systems.
RT-PCR direct Detection Kit is intended to be used to achieve direct detection of Severe acute respiratory syndrome coronavirus 2 viral RNA from nasal swabs, nasopharyngeal swabs and oropharyngeal swabs from patients with signs and symptoms of infection who are suspected of COVID-19. This product provides dual-detections of two independent genes of a single tube. gene and N gene is amplified and detected in FAM and HEX channel, respectively. An internal control is set with a Cy5 labeled probe using the RNase P gene of human as the target, to monitor the amplification effect of the detection system.
Our nucleic acid detection reagent can be transported at room temperature by freeze-drying technology, and can be stored at low temperature for a long time for one and a half years, and maintain good effectiveness.
This kit is intended for qualiativein vitro detection of Orf1ab and N genes of Novel Coronavirus 2019-nCoV which are found in throat swab,sputum and alveolar lavage fuid samples of suspected cases of pneumonia,suspected cases of clustering and other patients who need to carry out diagnosis or differential diagnosis of Novel Coronavirus 2019-nCoV infection.
Sample Types :
Including Nasopharyngeal swab, Oropharyngeal swab, Sputum
Controls :
Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results
Product Information
Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.
Authorized Laboratories
Laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.
About Emergency Use Authorization
(EUA)
This test (1) has not been FDA cleared or approved, (2) has been authorized by
FDA under an EUA for use by authorized laboratories, (3) has been authorized
only for the detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens, and (4) 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.
The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal
aspirate) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C.
263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory 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 infective status. The agent detected may not be
the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses.
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.
The COVID-19 RT-PCR Detection Kit is intended for use by qualified trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization.
PRINCIPLE OF DETECTION
This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will
be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N
gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel.
dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products.
Internal reference is used in the kit for quality control starting from sample collection
