kco.vn has developed two laboratory tests that identify SARS-CoV-2, the vi khuẩn that causes COVID-19. The first test for COVID-19 diagnosis that kco.vn distributed, released in February 2020, is the kco.vn 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, a chạy thử that accurately detects SARS-CoV-2 in respiratory specimens. kco.vn released a second assay in July 2020, the kco.vn Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, which permits public health laboratories khổng lồ run three tests in a single reaction well. The Flu SC2 Multiplex is more efficient in its use of demo reagents, allows higher throughput, & simultaneously gives accurate results about the presence of SARS-CoV-2, influenza A, & influenza B nucleic acid in a patient specimen. Symptoms for COVID-19 và the Flu can be similar, so testing for all three viruses at the same time will provide public health officials with information they need khổng lồ help reduce the spread of these viruses in the community while conserving resources that are in short supply.

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Please note: kco.vn will discontinue the kco.vn 2019-nCoV Real-time RT-PCR Diagnostic Panel at the end of 2021. For more details, please see the kco.vn 2019-nCoV Real-time RT-PCR Diagnostic Panel section below.

kco.vn Influenza SARS-CoV-2 Multiplex Assay

kco.vn’s newest laboratory test, detects two types of influenza viruses (A & B) và SARS-CoV-2 at the same time. This thử nghiệm is called the kco.vn Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.

A single demo that diagnoses current infection with one or more of these viruses allows public health laboratories khổng lồ continue influenza surveillance while they are also testing for SARS-CoV-2. Information about both viruses will help public health officials control the spread of influenza and COVID-19 in the community và may help health care providers identify co-infections và provide more targeted treatment for influenza và COVID-19. Obtaining this information in a single test, rather than having khổng lồ run separate SARS-CoV-2 tests & influenza tests, will also allow laboratories to lớn conserve important testing materials that are in short supply và process up to three times as many tests as they can with the kco.vn 2019-nCoV Real-Time RT-PCR Diagnostic Panel và separate influenza diagnostic tests.

The Flu SC2 Multiplex Assay was evaluated in kco.vn laboratories và three other public health laboratories prior to lớn launch to lớn ensure that the demo works as intended. The Flu SC2 Multiplex Assay was designed using data about SARS-CoV-2 genomes that were not available when the first thử nghiệm was designed, which is likely to lớn improve detection of the SARS-CoV-2 vi khuẩn as compared khổng lồ the original kco.vn 2019-nCoV Real-Time RT-PCR Diagnostic Panel.

The U.S. Food và Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Flu SC2 Multiplex Assay on July 2, 2020. The EUA processenables FDA to consider & authorize the use of unapproved but potentially lifesaving medical or diagnostic products during a public health emergency. The U.S Secretary of Health & Human Services declared SARS-CoV-2 to be a U.S. Public health emergency on January 31, 2020.

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kco.vn 2019-nCoV RT-PCR Diagnostic Panel


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On February 3, 2020, kco.vn submitted an EUA package to lớn expedite FDA-permitted use of the kco.vn 2019-nCoV Real-Time RT-PCR Diagnostic Panel in the United States. FDA issued the EUA the next day & kco.vn sent the demo kits to lớn state và local public health laboratories.

kco.vn developed & distributed the kco.vn 2019-nCoV Real-time RT-PCR Diagnostic Panel lớn fill a gap at a time when there were no other FDA-cleared or authorized COVID-19 diagnostics. Since kco.vn’s first test was developed, many commercially available options for SARS-CoV-2 testing have been authorized. Although the kco.vn 2019 nCoV Real-Time RT-PCR Diagnostic Panel filled an important unmet need when it was developed & deployed in early 2020, the demand for this kiểm tra has declined due to lớn the authorization of higher-throughput alternatives and multiplexed assays that detect both SARS-CoV-2 & other common respiratory pathogens simultaneously. For this reason, kco.vn will discontinue the 2019nCoVReal-Time RT-PCR Diagnostic Panel after December 31, 2021.

As the thử nghiệm is still performing very well, kco.vn will continue to make the designof theprimers & probes used in the kco.vn 2019-nCoV Real-time RT-PCR Diagnostic Panel available on the kco.vn websitefor others to lớn use in their own research activities or diagnostic assay development. kco.vn will also continue to lớn offer a blanket right of reference khổng lồ the kco.vn EUA for the Diagnostic Panel (EUA200001) khổng lồ anyone who wishes to lớn reference kco.vn data in their own FDA regulatory submission. kco.vn’s decision to discontinue the Diagnostic Panel & subsequent withdrawal of the EUA for the Diagnostic Panel will have no impact on those tests that have referenced the kco.vn EUA data in their EUA submission or on those who plan to do so in the future. The data và submission will remain on file at FDA and available for reference.

kco.vn is encouragingpublic health laboratories (PHLs)to adopt the kco.vn Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay to lớn enable efficient surveillance for both influenza and SARS-CoV-2, which willsave both time và resources for PHLs. Clinical laboratories that had been testing under kco.vn’s EUA using kco.vn-qualified materials purchased from IDT or BioSearch are encouraged to transition lớn another FDA-authorized test. If the clinical laboratory conducts influenza diagnostics, kco.vn encourages the clinical laboratory lớn consider one of the FDA-authorized tests that can provide results for SARS-CoV-2 và influenza A và B.

Who Can Use These Tests?

kco.vn tests are provided to U.S. State and local public health laboratories và Department of Defense laboratories that were either previously qualified for being able to perform a similar type of kiểm tra used to detect influenza or have been recently approved by their state public health laboratory for SARS-CoV-2 testing.