CoViD-19 Nucleic Acid Detection Kit
OaCP informs that the CoViD-19 Nucleic Acid Detection Kit is not a domestic use kit and that the contents of this site are intended exclusively for healthcare professionals.
CoViD-19 Detection Kit
Clinical significance: According to the “New Coronavirus Pneumonia Infection Diagnosis and Treatment Plan” (Trial Version 5) the CoViD 19 nucleic acid test is the gold standard for the diagnosis of suspected patients.
- Accurate results: the kit contains an internal standard to avoid false negative results and ensure the accuracy of the test result.
- Anti-pollution: the principle of “One step” PCR technology reduces reaction time and avoids aerosol pollution.
- High sensitivity: the minimum detection baseline is 500 copies/mL, which ensures the detection of low virus content sample results.
- High-throughput: triple PCR reaction system, high detection flux, timely and rapid completion of multiple sample detection.
- CE-IVD and CFDA approved (FDA Fact sheet for Healthcare Providers – FDA Fact sheet for Patients – FDA IFU)
OaCP and its kit have been listed as certified entities in the Circular of Italy’s Ministry of Health published on 04/03/2020. The document contains updates about indications on diagnostic tests and criteria to follow in the determination of priorities within COVID-19 pandemic.
World Health Organization (WHO) has defined our types of test within the best methods for the detection and identification of SARS-CoV-2 and variants.