Chinyararire pasina kutariswa nevezvenhau, iyo US Center for Disease Control and Prevention (CDC) yakabvisa maitiro ePCR semuyedzo unoshanda wekuona uye kuona SARS-CoV-2.
CDC yave kubvuma kuti PCR bvunzo haigone kusiyanisa pakati peSARS-CoV-2 nehutachiona hwefuruwenza.
Ichangobva kuburitswa Laboratory Alert yakapihwa neCDC inoti:
Mushure meZvita 31, 2021, CDC ichabvisa chikumbiro kuUS Food and Drug Administration (FDA) yeEmergency Use Authorization (EUA) yeCDC 2019-Novel Coronavirus (2019-nCoV) Real-Nguva RT-PCR Diagnostic Panel, iyo assay yakatanga kuunzwa muna Kukadzi 2020 yekuonekwa kweSARS-CoV-2 chete.
CDC ichangopa chiziviso chepamberi kuti marabhoritari ekiriniki ave nenguva yakakwana yekusarudza nekuita imwe yedzimwe nzira dzakawanda dzakatenderwa neFDA.
Iyo FDA webhusaiti ine runyorwa rwezvakatenderwa COVID-19 nzira dzekuongorora. Kuti uwane pfupiso yekushanda kweFDA-yakatenderwa mamorekuru nzira ine FDA referensi panhi, shanyira peji ino.
Kune akati wandei marudzi eSARS-CoV-2 uye COVID-19 ane hukama IVDs:
- Kuongorora Kuongorora: Miedzo inoona zvikamu zvehutachiona hweSARS-CoV-2 uye inogona kushandiswa kuongorora hutachiona nehutachiona hweSARS-CoV-2. Izvi zvinosanganisira ma molecular test uye antigen bvunzo.
- Serology/Antibody uye Mamwe Anodaptive Immune Response Miedzo: Miedzo inoona masoja ekudzivirira chirwere (semuenzaniso, IgM, IgG) kuhutachiona hweSARS-CoV-2 kana iyo inoyera mhinduro yakasiyana yekudzivirira immune (senge, T cell immune immune reaction) kuhutachiona hweSARS-CoV-2. Aya marudzi ebvunzo haagone kushandiswa kuona hutachiona hwazvino.
- Bvunzo dzeManejiro eVarwere veCOVID-19: Kupfuura bvunzo dzinoongorora kana kuona SARS-CoV-2 hutachiona kana masoja ekudzivirira chirwere, kune zvakare bvunzo dzakatenderwa kushandiswa mukutarisira kwevarwere vane COVID-19, sekuona ma biomarkers ane chekuita nekuzvimba. Kana varwere vangoonekwa vaine chirwere cheCCIDID-19, iyi mimwe miedzo inogona kushandiswa kuzivisa sarudzo dzekutonga kwevarwere.
Mukugadzirira shanduko iyi, CDC inokurudzira marabhoritari ekiriniki uye nzvimbo dzekuyedza dzanga dzichishandisa CDC 2019-nCoV RT-PCR assay sarudza uye vatange shanduko yavo kune imwe FDA-yakatenderwa COVID-19 bvunzo.
CDC inokurudzira marabhoritari kuti atarise kutorwa kwenzira yakapetwa yakawanda inogona kufambisa kuonekwa nekusiyaniswa kweSARS-CoV-2 uye hutachiona hwefuruwenza. Mayedzo akadai anogona kufambisa kuenderera mberi kwekuyedzwa kwefuruwenza uye SARS-CoV-2 uye inogona kuchengetedza zvese nguva nezviwanikwa patiri kupinda mumwaka wefuruwenza. Marabhoritari nenzvimbo dzekuyedza dzinofanirwa kutsigira nekusimbisa bvunzo yavo yakasarudzwa mukati menzvimbo yavo vasati vatanga kuongororwa kwekiriniki.
Vamwe vanotaura vachipokana nejekiseni, senyanzvi yeBelgian mukutarisira kwakanyanya Dr. Pascal Sacre, vakati maitiro eRT-PCR akashandiswa zvisizvo uye akashandiswa senzira isingaregi uye ine chinangwa kugadzira kutaridzika kwedenda rakavakirwa pamhedzisiro yekunyepedzera uye kwete. chaivo varwere veCovid kuitira kutyora kodzero dzevanhu nebumbiro revagari.