Product Name: OZO Sansure 2019-nCoV nucleic acid detection kit
Technology: One-tube fast test/Mag-beads
Sensitivity: 200 copies/ml
Lysis: Room temperature lysis
Sample Type: Alveolar lavage fluid, throat swab, sputum
Internal standard system: Endogenous housekeeping gene
Target gene: ORF 1ab and N gene
Packaging specifications: 24 samples/box
The OZO Novel Coronavirus (2019-nCoV) PCR Kits are a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS- CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid- turbinate swabs, nasal washes and nasal aspirates from individuals who are 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.
The OZO Novel Coronavirus (2019-nCoV) PCR Kits are 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 OZO Simcere Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in 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 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.
"Early detection, early quarantine, and early treatment" are effective strategies to control the spread of the pandemic.
Real-time fluorescent RT-PCR detection of SARS-CoV-2 nucleic acid test (+) is the basis for the diagnosis of COVID-19, and SARS-CoV-2 nucleic acid test (-) is an important criterion for hospital discharge and quarantine release.
The simple operation, fast, and high-throughput of SARS-CoV-2 nucleic acid detection technology represents great significance for the rapid screening of high-risk populations
Accurate and highly sensitive nucleic acid detection technology provides a powerful tool for the diagnosis and treatment of COVID-19.
Flow chart for the diagnosis of suspected COVID-19 cases
Global unique One-tube method is the fastest & easiest RT-PCR test in the world and does not require heating, change tubes, finish sample preparation in 10 minutes. 96 samples run in one time; report results within 2 hours.
The internal standard uses endogenous housekeeping genes to monitor sampling and testing to avoid false negatives.
Inactivation program + powerful inactivating lysate to protect laboratory personnel.
It can be perfectly matched with multi channel quantitative PCR instruments, such as ABI7500, SLAN-96P PCR system, Life Technologies QuantStudioTM5 PCR system, MA-6000 PCR system etc.
200copies / ml (one-tube method).
High specificity by using multiple fluorescence detection technology, three fluorescent channels can be used to detect ORF 1ab, N gene targets and internal standards. Multiple targets ensure specificity and avoid missed detection.