Nyocha QUIDEL QuickVue SARS Antigen
Ezubere iji
Nnwale QuickVue SARS Antigen bụ immunoassay nke na-erugharị n'akụkụ nke na-enye ohere maka nchọpụta ngwa ngwa nke nucleocapsid protein antigen sitere na SARS-CoV-2 na azụ azụ (NS) swab nke sitere na ndị mmadụ na-enyo enyo na COVID-19 site na nlekọta ahụike ha. onye na-eweta n'ime ụbọchị ise mbụ nke mmalite nke mgbaàmà. Nnwale nwere oke na ụlọ nyocha enwetara ikike n'okpuru mmezi mmezi ụlọ nyocha ahụike nke 1988 (CLIA), 42 USC §263a, nke na-emezu ihe achọrọ iji mee ule dị oke oke, dị elu ma ọ bụ wepụrụ mgbagwoju anya. Enyere ikike nnwale a maka ojiji na Point of Care (POC), ya bụ, ntọala nlekọta ndị ọrịa na-arụ ọrụ n'okpuru Asambodo Waiver CLIA, Asambodo nnabata, ma ọ bụ Asambodo nzere. Nnwale QuickVue SARS Antigen adịghị iche n'etiti SARS-CoV na SARS-CoV-2. Nsonaazụ bụ maka njirimara SARS-CoV-2 nucleocapsid protein antigen. A na-achọpụtakarị antigen n'ụdị nrịanrịa azụ n'oge oke ọrịa. Nsonaazụ dị mma na-egosi ọnụnọ nke nje antigens, mana njikọ ụlọ ọgwụ na akụkọ ihe mere eme nke onye ọrịa na ozi nyocha ndị ọzọ dị mkpa iji chọpụta ọnọdụ ọrịa. Nsonaazụ dị mma anaghị ewepụ ọrịa nje ma ọ bụ njikọ nje na nje ndị ọzọ. Onye nnọchi anya achọpụtara nwere ike ọ gaghị abụ ihe kpatara ọrịa ahụ. Ụlọ nyocha dị n'ime United States na mpaghara ya ka achọrọ ka ha kọọrọ ndị ọrụ ahụike ọha kwesịrị ekwesị. Ekwesịrị ịgwọ nsonaazụ na-adịghị mma dị ka ihe nleba anya na nkwenye site na nyocha mkpụrụ ndụ, ọ bụrụ na ọ dị mkpa, maka njikwa onye ọrịa, enwere ike ịrụ ya. Nsonaazụ ọjọọ anaghị ewepụ COVID-19 na e kwesịghị iji ya mee naanị ihe ndabere maka ọgwụgwọ ma ọ bụ mkpebi njikwa onye ọrịa, gụnyere mkpebi njikwa ọrịa. Ekwesịrị ịtụle nsonaazụ na-adịghị mma n'ọnọdụ mkpughe nke onye ọrịa n'oge na-adịbeghị anya, akụkọ ihe mere eme, yana ọnụnọ nke akara na mgbaàmà ụlọ ọgwụ kwekọrọ na COVID-19. Emebere ule QuickVue SARS Antigen maka ojiji site n'aka ndị ọrụ ụlọ nyocha ụlọ ọgwụ a zụrụ azụ yana ndị a zụrụ azụ na ntọala nlekọta. Nnwale QuickVue SARS Antigen bụ naanị maka ojiji n'okpuru ikike ojiji ihe mberede nke nchịkwa nri na ọgwụ.
Nchịkọta na Nkọwa
SARS-CoV-2, nke a makwaara dị ka nje COVID-19, bụ nke izizi chọpụtara na Wuhan, Province Hubei, China na Disemba 2019. A na-eche na nje a, dị ka ọ dị na coronavirus ọhụrụ SARS-1 na MERS, sitere na ụsụ. , Otú ọ dị, SARS-CoV-2 nwere ike ịbụ onye na-elekọta mmadụ dị ka pangolins, na pigs, ma ọ bụ civets.1 WHO kwupụtara na COVID-19 bụ ọrịa na-efe efe na Machị 11, 2020, na ọrịa mmadụ agbasawo n'ụwa nile, yana Ọtụtụ narị puku mmadụ enwetara ọrịa na ọnwụ.2 A na-eche na oge nnabata etiti ga-abụ ụbọchị 5.1 yana akara ngosi a na-atụ anya na ọ ga-adị n'ime ụbọchị iri na abụọ nke ọrịa.12 Ihe mgbaàmà nke COVID-3 yiri ọrịa iku ume ndị ọzọ nke viral yana gụnyere ahụ ọkụ, ukwara, na iku ume.19
Ụkpụrụ nke usoro
Nnwale QuickVue SARS Antigen na-arụ ọrụ teknụzụ immunoassay nke mpụta. Iji ule a na-enye ohere maka nchọpụta ngwa ngwa nke protein nucleocapsid sitere na SARS-CoV na SARS-CoV-2. Nnwale a na-enye ohere maka nchọpụta SARS-CoV na SARS-CoV-2 mana ọ naghị ekewa n'etiti nje abụọ a.
Iji bido ule ahụ, a ga-emerịrị reagent lyophilized n'ime tube reagent. Nke a reagent na-eme ka ikpughe antigens viral dabara adaba na ọgwụ mgbochi eji eme nnwale ahụ. A na-ebu ụzọ mee ka reagent nweta mmiri site na Ngwọta Reagent enyere, ma tinyezie swab n'ime Reagent Tube. Reagent a na-emekọrịta ihe n'ụdị ahụ ma na-eme ka ikpughe antigens nke nje virus kwesịrị ekwesị na ọgwụ mgbochi ejiri na ule ahụ. A na-agbakwunye eriri ule na Reagent Tube ugbu a nwere ihe nlere na Ngwọta Reagent.
Ọ bụrụ na ụdị amịpụtara nwere SARS-CoV ma ọ bụ SARS-CoV-2 antigens, ahịrị nnwale pink-na-acha ọbara ọbara, yana ahịrị njikwa usoro na-acha anụnụ anụnụ ga-apụta na eriri ule na-egosi nsonaazụ dị mma. Ọ bụrụ na SARS-CoV ma ọ bụ SARS-CoV-2 anọghị ma ọ bụ nọ na ọkwa dị ala, ọ bụ naanị ahịrị njikwa usoro na-acha anụnụ anụnụ ga-apụta.
Reagent na ihe ndị e nyere
Ngwa ule 25
- Mpempe ule ejikọtara n'otu n'otu (25): ọgwụ mgbochi SARS monoclonal
- Reagent Tubes (25): Ihe nchekwa Lyophilized nwere ihe nchacha na ihe na-ebelata
- Ngwọta Reagent (25): Vials nwere ngwọta nnu 340 μL
- Swabs imi na-adịghị mma (Kit #20387) (25)
- Swab njikwa mma nke SARS (1): A na-ekpuchi swab na antigens SARS na-anaghị efe efe.
- Swab Control Na-adịghị mma (1): A na-ekpuchi swab na antigen Streptococcus C na-adịghị efe efe na-ekpo ọkụ.
- Ntinye ngwugwu (1)
- Usoro Kaadị (1)
A naghị enyefe ihe
- Ngụ oge ma ọ bụ nche
- Ntọala swab nke SARS Antigen nke QuickVue maka QC ọzọ (20389)
- Ụgbọ njem akọrọ (SKU # 20385) (25). Na-echekwa na ụlọ okpomọkụ.
Ịdọ aka ná ntị na ịkpachara anya
- Maka iji diagnostic in vitro
- Maka iji naanị ndenye ọgwụ
- Emebebeghị FDA ma ọ bụ kwado ngwaahịa a; mana FDA enyela ya ikike n'okpuru ikike iji ihe mberede (EUA) maka ojiji site na ụlọ nyocha enwetara n'okpuru CLIA nke na-emezu ihe achọrọ iji mee ule mgbagwoju anya, dị elu ma ọ bụ wepụrụ. Enyere ngwaahịa a ikike maka ojiji na Point of Care (POC), ya bụ, ntọala nlekọta ụlọ ọgwụ na-arụ ọrụ n'okpuru Asambodo CLIA, Asambodo nnabata, ma ọ bụ Asambodo nzere.
- Enyere ikike ngwaahịa a naanị maka nchọpụta nke protein site na SARS-CoV-2, ọ bụghị maka nje ma ọ bụ nje ọ bụla ọzọ.
- Nnwale a ka enyere ikike maka ogologo oge nkwupụta na ọnọdụ dị adị na-akwado ikike nke iji ihe mberede nke nnwale diagnostic in vitro maka nchọpụta na/ma ọ bụ nyocha nke COVID-19 n'okpuru ngalaba 564(b)(1) nke Iwu, 21 USC § 360bbb-3(b)(1) belụsọ na akwụsị ma ọ bụ kagbuo ikike ngwa ngwa.
- Ejila ọdịnaya ngwa ahụ gafere ụbọchị njedebe nke ebipụtara na mpụga igbe ahụ.
- Yiri uwe nchebe kwesịrị ekwesị, uwe aka (nitrile ma ọ bụ latex), na nchebe anya / ihu mgbe ị na-ejizi s onye ọrịa.amples ma ọ bụ ihe ngwa ngwa eji eme ihe.
- Ngwọta Reagent nwere ngwọta nnu (saline). Ọ bụrụ na ngwọta ahụ metụtara akpụkpọ ahụ ma ọ bụ anya, were oke mmiri wụsa.
- Ejighachila eriri nnwale ejiri, Reagent Tubes, ngwọta, ma ọ bụ swabs njikwa.
- Eriri ule ahụ ga-anọgiderịrị na-emechi ya n'ime obere akpa foil nchebe ruo mgbe ejiri ya. Onye ọrụ ekwesịghị imeghe obere akpa foil nke eriri ule na-ekpughe ya na gburugburu gburugburu ruo mgbe eriri ule dị njikere maka ojiji ozugbo. Ọ bụrụ na warara ule mepere otu awa ma ọ bụ karịa, nsonaazụ ule na-ezighi ezi nwere ike ime.
- A ga-ejirịrị ngwa nyocha QuickVue SARS Antigen na ihe nchekwa lyophilized na reagent nke enyere na ngwa ahụ.
- Nchịkọta nke ọma, nchekwa, na njem dị oke mkpa maka ịrụ ọrụ nke ule a. Chọọ ọzụzụ ma ọ bụ ntụzịaka akọwapụtara ma ọ bụrụ na ị nwebeghị ahụmịhe na usoro nchịkọta na njikwa ihe atụ.5,6,7,8.
- Mgbe ị na-anakọta imi imi sample, jiri imi imi enyere na ngwa (Kit #20387)
- Nchịkọta ezughị oke ma ọ bụ ezighi ezi, nchekwa, na mbugharị nwere ike iwepụta nsonaazụ ule adịgboroja.
- Iji nweta nsonaazụ ziri ezi, ị ga-esorịrị ntuziaka Fanye ngwugwu.
- Ndị nwere ọhụhụ ụcha nwere ike ọ gaghị enwe ike ịkọwa nsonaazụ ule nke ọma.
- Ekwesịrị ime nnwale na mpaghara nwere ikuku ikuku zuru oke.
- Tụfuo arịa na ọdịnaya ejighi ya dịka iwu gọọmentị etiti, steeti na mpaghara chọrọ.
- Sachaa aka nke ọma mgbe ejirichara ya.
- Maka ozi ndị ọzọ gbasara nchekwa, njikwa na mkpofu ihe ndị dị n'ime ngwa a, biko rụtụ aka na mpempe akwụkwọ nchekwa nchekwa (SDS) dị na quidel.com.
Nchekwa ngwa na kwụsie ike
- Chekwaa ngwa ahụ na okpomọkụ dị n'ime ụlọ, 59°F ruo 86°F (15°C ruo 30°C), pụọ na ìhè anyanwụ kpọmkwem. Ọdịnaya ngwa ahụ kwụsiri ike ruo mgbe ebipụtara ụbọchị ngwụcha n'igbe dị n'elu. Ajụla oyi.
Mkpokọta na njikwa ihe atụ - Nchịkọta na njikwa nke ọma dị oke mkpa maka ịrụ ọrụ nke ule a. 5,6,7,8 Nchịkọta Nasal Swab S.ample
- Jiri imi imi ewetere na ngwa ahụ.
- Tupu ịnakọta swab imi, a ga-agwa onye ọrịa ka ọ gbaa imi ya. Ịnakọta imi imi sample, fanye ọnụ ọnụ swab ahụ dum (na-abụkarị ½ ruo ¾ nke inch (1 ruo 1.5 cm) n'ime imi imi wee kwụsie ike s.ample mgbidi imi site n'ịtụgharị swab n'ụzọ okirikiri megide mgbidi imi ọ dịkarịa ala ugboro 4. Were ihe dị ka sekọnd iri na ise iji nakọta sample. Jide n'aka na ị ga-anakọta drainage ọ bụla nke nwere ike ịdị na swab.
- Sample imi abua nwere otu swab.
SampỤgbọ njem na Nchekwa SampA ga-anwale les ozugbo enwere ike mgbe nchịkọtachara. Dabere na data emepụtara na QuickVue SARS Antigen Test, imi imi na-akwụsi ike ruo awa 120 n'ime ụlọ ma ọ bụ 2° ruo 8°C n'ime tube njem dị ọcha, kpọrọ nkụ.
Njikwa ogo
Enwere ụdị njikwa ogo abụọ bụ isi maka ngwaọrụ a: njirimara njikwa arụnyere akọwapụtara n'okpuru yana njikwa mpụga.
Atụmatụ njikwa arụnyere arụnyere
Nnwale QuickVue SARS Antigen nwere njirimara njikwa usoro arụnyere n'ime ya. Ndụmọdụ onye nrụpụta maka njikwa kwa ụbọchị bụ idetu njikwa usoro ndị a arụnyere maka s nke mbụample ule kwa ụbọchị.
Ụdị nsonaazụ agba abụọ na-enye nkọwa dị mfe nke nsonaazụ dị mma na nke na-adịghị mma. Ọdịiche nke ahịrị njikwa usoro na-acha anụnụ anụnụ na-enye njikwa dị mma site n'igosipụta oke erutela nke ọma ma na-edobe iguzosi ike n'ezi ihe nke eriri ule ahụ. Ọ bụrụ na ahịrị njikwa usoro na-acha anụnụ anụnụ etoliteghị n'ime nkeji iri na eriri ule, mgbe ahụ nsonaazụ ule adịghị mma.
A na-enye njikwa na-adịghị mma arụnyere n'ime ya site na ikpochapụ nke agba ndabere na-acha uhie uhie, na-achọpụta na e meela ule ahụ nke ọma. N'ime nkeji 10, mpaghara nsonaazụ kwesịrị ịdị ọcha ka ọ bụrụ pink pink ma kwe ka nkọwa doro anya nke nsonaazụ ule ahụ. Ọ bụrụ na agba n'okirikiri ka dị ma na-egbochi nkọwa nke nsonaazụ ule, mgbe ahụ nsonaazụ ule abaghị uru. Ọ bụrụ na nke a emee, regharịaview usoro ma megharịa ule ahụ na onye ọrịa ọhụrụ sample na ụzọ ule ọhụrụ. Ọ dị mkpa ịnakọta ụdị ọrịa ọzọ; Enweghị ike ijikwa swabs ma ọ bụ reagent ndị ọrịa ọzọ.
Njikwa Ogo Mpụga
Enwere ike iji njikwa mpụga gosi na reagents na usoro nyocha na-arụ ọrụ nke ọma.
Quidel na-atụ aro ka a na-agba ọsọ njikwa dị mma na nke na-adịghị mma otu ugboro maka onye ọrụ ọ bụla a na-azụghị ọzụzụ, otu ugboro maka ngwa ngwa ọhụrụ ọ bụla - ma ọ bụrụhaala na a nwalere nza ọ bụla dị iche iche enwetara na mbupu - yana dịka e chere na ọ dị mkpa site na usoro njikwa mma nke ime gị, yana dabere na ya. nwere ụkpụrụ mpaghara, steeti na gọọmentị etiti ma ọ bụ ihe nzere nzere chọrọ.
Ekwesịrị iji usoro nnwale akọwapụtara na ntinye ngwugwu mgbe ị na-anwale njikwa mpụga.
Ọ bụrụ na njikwa anaghị arụ ọrụ dịka a tụrụ anya, megharịa ule ahụ ma ọ bụ kpọtụrụ Nkwado nka na ụzụ Quidel tupu ịnwale ụdị onye ọrịa.
Enwere ike nweta Swabs Swabs njikwa ndị ọzọ iche site na ịkpọtụrụ Quidel's Support Services na (800) 874.1517 (akwụghị ụgwọ na USA) ma ọ bụ (858) 552.1100.
Usoro ule
Ihe nlele na ihe nlere ụlọ ọgwụ ga-adịrịrị na ọnụ ụlọ tupu ịmalite nyocha.
Ụbọchị nkwubi: Lelee njedebe na ngwungwu ule nke ọ bụla ma ọ bụ igbe dị n'èzí tupu i jiri ya. Ejila ule ọ bụla gafere ụbọchị njedebe na labelụ.
Usoro ule swab imi
- Tinye ihe ngwọta reagent na tube reagent. Jiri nwayọọ tụgharịa tube ahụ ka ọ gbazee ọdịnaya ya.
- The Reagent Tube kwesịrị ịdị na-ejide tube maka ule niile.
- Ozugbo tinye onye ọrịa swab sampbanye na Reagent Tube. Bugharịa swab ahụ opekempe nke ugboro atọ (3) ka ị na-apị isi na ala na akụkụ nke Reagent Tube.
- Debe swab n'ime tube maka otu nkeji (1).
- Nsonaazụ ezighi ezi ma ọ bụ ezighi ezi nwere ike ime ma ọ bụrụ na oge nnabata ahụ dị mkpụmkpụ ma ọ bụ ogologo.
- Gosipụta mmiri niile sitere na isi swab site na ịtụgharị swab opekempe ugboro atọ (3) ka a na-ewepụ swab ahụ. Tụfuo swab dị ka ụkpụrụ mkpofu ihe mkpofu biohazard siri dị.
- Tinye eriri Ule n'ime Reagent Tube na akụ ndị na-atụ aka ala. Ejila ma ọ bụ bugharịa eriri ule ahụ ruo mgbe ule zuru oke ma dị njikere maka ịgụ ihe.
- N'ime nkeji iri (10), wepụ ihe nlele ule, wee gụọ nsonaazụ ya n'ime nkeji ise (5) dịka ngalaba nkọwa nke nsonaazụ.
Ekwesịrị ịgụpụta ibe ule n'etiti nkeji iri na iri na ise ka etinyechara n'ime tube reagent. Nsonaazụ adịgboroja, nke na-adịghị mma, ma ọ bụ nke na-ezighi ezi nwere ike ime ma ọ bụrụ na agụpụta mpempe akwụkwọ ahụ gafere oge akwadoro.
NKWU OKWU KWESỊRỊ
- Nsonaazụ dị mma*:
- N'ime nkeji iri (10), mpụta nke ndò ọ bụla nke ahịrị ule pink na-acha ọbara ọbara na ọdịdị nke ahịrị njikwa usoro na-acha anụnụ anụnụ na-egosi nsonaazụ dị mma maka ọnụnọ SARS antigen. Nsonaazụ ga-adịgide adịgide ruo nkeji ise (5) ka oge agụchara akwadoro. Agụla nsonaazụ ihe karịrị nkeji iri na ise ka etinyechara ya na tube Reagent.
- * Nsonaazụ dị mma anaghị ewepụ ọrịa nje ndị ọzọ na-efe efe.
- ∗Legidenụ anya! Nke a bụ nsonaazụ dị mma. Ọbụlagodi na ị hụla ahịrị nnwale pink na-acha anụnụ anụnụ, ị ga-akọrịrị nsonaazụ ya dị ka POSITIVE.
- C = akara njikwa
- T = ahịrị ule
Nsonaazụ adịghị mma**:
- N'ime nkeji iri (10), mpụta nke naanị ahịrị njikwa usoro na-acha anụnụ anụnụ na-egosi na achọpụtaghị SARS antigen. Nsonaazụ ga-adịgide adịgide ruo nkeji ise (5) ka oge agụchara akwadoro. Agụla nsonaazụ ihe karịrị nkeji iri na ise ka etinyechara ya na tube Reagent.
- ** Nsonaazụ na-adịghị mma anaghị ewepu ọrịa SARS-CoV-2. Ekwesịrị ka ewere nsonaazụ na-adịghị mma dị ka nke a na-eche na ọ ga-adị mkpa ka ejiri nyocha mkpụrụ ndụ kwado ya.
Nsonaazụ Na-ezighi ezi
- Ọ bụrụ na nkeji iri (10), akara njikwa usoro na-acha anụnụ anụnụ anaghị apụta, ọ bụrụgodị na ndò ọ bụla nke ahịrị ule pink na-acha ọbara ọbara pụtara, nsonaazụ ya abaghị uru.
- Ọ bụrụ na nkeji iri (10), ụcha okirikiri anaghị achacha ma na-egbochi agụ nke ule ahụ, nsonaazụ ya abaghị uru.
- Ọ bụrụ na nsonaazụ ya ezighi ezi, ekwesịrị iji onye ọrịa ọhụrụ mee nnwale ọhụrụample na ụzọ ule ọhụrụ.
OKWU
- Ezubere ule a maka naanị ụdị swab ozugbo. Agaghị eji Media Transport Media (VTM) mee nnwale a n'ihi na ọ nwere ike ibute nsonaazụ ụgha.
- A ga-eji ihe ndị dị n'ime ngwa a naanị maka nchọpụta qualitative nke SARS antigens sitere na ụdị swab nke ihu ihu.
- Nsonaazụ ule na-adịghị mma nwere ike ime ma ọ bụrụ na ọkwa antigen dị kaample nọ n'okpuru oke nchọpụta nke ule ma ọ bụ ọ bụrụ na sampa na-anakọta le na-ekwesịghị ekwesị.
- Nnwale a na-achọpụta ma enwere ike (ndụ) na enweghị ike, SARS-CoV, na SARS-CoV-2. Nnwale ule dabere na ọnụọgụ nje (antigen) dị na sampna nwere ike ma ọ bụ ọ gaghị ejikọta ya na nsonaazụ omenala nje emere n'otu sample.
- Ọdịda ịgbaso usoro nnwale na nkọwapụta nsonaazụ nwere ike imetụta arụmọrụ ule na/ma ọ bụ mebie nsonaazụ nnwale ahụ.
- A ga-enyocharịrị nsonaazụ ule yana njikọ data ụlọ ọgwụ ndị ọzọ dị maka dọkịta.
- Nsonaazụ ule na-adịghị mma ezubere ịchị achị na nje ndị ọzọ na-abụghị SARS ma ọ bụ nje na-efe efe.
- Nsonaazụ ule dị mma anaghị ewepụ nje na nje ndị ọzọ.
- Ekwesịrị ịgwọ nsonaazụ na-adịghị mma dị ka ihe nleba anya, yana nkwenye site na nyocha mkpụrụ ndụ, ọ bụrụ na ọ dị mkpa maka njikwa onye ọrịa, enwere ike ime ya.
- Ọ bụrụ na achọrọ ọdịiche nke nje na SARS a kapịrị ọnụ, achọrọ nyocha ọzọ, yana ndị ngalaba obodo ma ọ bụ mpaghara ahụike ọha na eze.
Ọnọdụ ikike maka ụlọ nyocha na ntọala nlekọta ndị ọrịa.
- Akwụkwọ ikike ikike QuickVue SARS Antigen, yana akwụkwọ akụkọ ikike enyere ikike maka ndị na-enye nlekọta ahụike, akwụkwọ ozi enyere ikike maka ndị ọrịa, yana akara ikike dị na FDA. websaịtị: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
- Agbanyeghị, iji nyere ụlọ nyocha ụlọ ọgwụ aka iji QuickVue SARS Antigen Test (“ngwaahịa gị” n'ọnọdụ ndị dị n'okpuru), edepụtara ọnọdụ ikike dị mkpa n'okpuru:
- Ụlọ nyocha enyere ikike* nke na-eji ngwaahịa gị ga-agụnye mkpesa rịzọlt ule, yana akwụkwọ akụkọ niile enyere ikike. N'ọnọdụ dị oke egwu, enwere ike iji ụzọ ndị ọzọ dabara adaba maka ịgbasa akwụkwọ akụkọ ndị a, nke nwere ike ịgụnye mgbasa ozi.
- Ụlọ nyocha enyere ikike na-eji ngwaahịa gị ga-eji ngwaahịa gị dị ka akọwapụtara n'akwụkwọ akara ikike. Agaghị anabata ngbanwe sitere na usoro enyere ikike, gụnyere ngwa enyere ikike, ụdị ụdị ụlọ ọgwụ enyere ikike, ihe njikwa ikike, reagents ndị ọzọ enyere ikike na ihe enyere ikike achọrọ iji ngwaahịa gị.
- Ụlọ nyocha ikike ikike na-enweta ngwaahịa gị ga-agwa ndị ọrụ ahụike ọha dị mkpa maka ebumnuche ha ịme ngwaahịa gị tupu ịmalite nyocha.
- Ụlọ nyocha enyere ikike na-eji ngwaahịa gị ga-enwerịrị usoro maka ịkọrọ ndị na-ahụ maka ahụike na ndị ọrụ ahụike ọha dị mkpa, dị ka okwesịrị.
- Ụlọ nyocha ndị enyere ikike ga-anakọta ozi gbasara arụmọrụ ngwaahịa gị wee kọọ DMD/OHT7-OIR/OPEQ/CDRH (site na email: CDRH-EUA-Reporting@fda.hhs.gov) na Quidel (site na email:
QDL.COV2.test.event.report@quidel.com, ma ọ bụ site na ekwentị site na ịkpọtụrụ Quidel Ọrụ Nkwado Ndị Ahịa na 800.874.1517 (na US) ma ọ bụ 858.552.1100) ihe ọ bụla a na-enyo enyo na ọ bụ nsonaazụ ọjọọ ụgha ma ọ bụ ụgha na nhụsianya dị ukwuu. site na njirimara arụmọrụ arụ ọrụ nke ngwaahịa gị nke ha na-amata. - Ndị ọrụ niile na-eji ngwaahịa gị ga-enwerịrị ọzụzụ nke ọma n'ịrụ na ịkọwa nsonaazụ ngwaahịa gị, jiri akụrụngwa nchekwa nkeonwe dabara adaba mgbe ị na-eji ngwa a, wee jiri ngwaahịa gị dịka akara ahaziri.
- Ụlọ ọrụ Quidel, ndị nkesa ikike, na ụlọ nyocha ikike na-eji ngwaahịa gị ga-ahụrịrị na edobere ndekọ ọ bụla metụtara EUA ruo mgbe FDA mara ọkwa ọzọ. A ga-emerịrị ihe ndekọ ndị dị otú ahụ maka FDA maka nyocha mgbe a rịọrọ ya.
Arụmọrụ arụmọrụ
Etulere ule QuickVue SARS Antigen na ntụnye aka ewepụtara EUA SARS-CoV-2 RT-PCR Assay na-eji ụdị swab oyi kpọnwụrụ na nke ọhụrụ dabara adaba.
Otu narị na iri ise na isii (156) dabara n'azụ nares swab ụdị sitere n'aka ndị ọrịa chere na ha nwere COVID-19 n'ime ụbọchị ise nke mgbaàmà mmalite sitere na saịtị nchịkọta US atọ. E zigara ihe nlele ahụ na ngwugwu oyi na ụlọ nyocha Quidel dị na Athens, Ohio. A na-eme nyocha nyocha SARS-CoV-2 RT-PCR Assay n'otu n'ime swabs dabara dị ka ntuziaka ngwaọrụ ahụ si dị. Iri ise na isii (56) nke swabs fọdụrụ bụ oyi kpọnwụrụ na -70°C tupu anwale ya na QuickVue SARS Antigen Test. N'ụbọchị QuickVue na-anwale swabs a gbazere wee nwalee ya na QuickVue SARS Antigen Test. A nwalere otu narị (100) swabs dị ọhụrụ, n'ime awa iri abụọ na anọ nke mkpokọta, yana QuickVue SARS Antigen Test.
Iri atọ na asatọ (38) dabara n'ihu nares swab ụdị sitere n'aka ndị ọrịa a na-enyo enyo na ha nwere COVID-19 n'ime ụbọchị ise nke mgbaàmà mmalite sitere na ọmụmụ ụlọ ọgwụ na-aga n'ihu na saịtị atọ (3) POC, yana abụọ (2) zụrụ nke ọma. ndị na-arụ ọrụ kwa saịtị POC. A nwalere otu swab na saịtị POC na QuickVue SARS Antigen Test site n'aka ndị ọrụ isii zụrụ obere azụ n'ụbọchị nchịkọta. Enyere ndị na-arụ ọrụ naanị ntuziaka nnwale na ntuziaka ntụaka ngwa ngwa. E zigara swabs dabara na ngwugwu oyi na ụlọ nyocha Quidel dị na Athens, Ohio maka nnwale SARS-CoV-2 RT-PCR. Emere nlebanya amịpụtara SARS-CoV-2 RT-PCR Assay na swabs dabara na ntuziaka ngwaọrụ maka ojiji.
Tebụlụ dị n'okpuru na-achịkọta data sitere na ụdị ọhụrụ (138) na oyi kpọnwụrụ (56)
| Ntụle nke QuickVue SARS Antigen Test na ihe nleba anya nke EUA Molecular comparator nyere ikike yana dakọtara.
ihu nares swabs |
|||||||||
| Ụdị ụdị | Nọmba
nwalere |
Eziokwu
Nke dị mma |
Ụgha
Nke dị mma |
Eziokwu
Ihe ọjọọ |
Ụgha
Ihe ọjọọ |
PPA% | NPA% | PPA 95%
CI |
NPA 95%
CI |
| Ụdị ọhụrụ | 138 | 30 | 1 | 106 | 1 | 96.8 | 99.1 | 83.8 na
99.4 |
94.9 na
99.8 |
| oyi kpọnwụrụ
Ụdị |
56 | 26 | 0 | 29 | 1 | 96.3 | 100 | 81.7 na
99.3 |
88.3 na
100 |
| Ejikọtara
Ụdị |
194 | 56 | 1 | 135 | 2 | 96.6 | 99.3 | 88.3 na
99.0 |
96.0 na
99.9 |
NKWUKWU NDAL AHALR.
Oke nke nchọpụta
- Ekpebiri oke nchọpụta (LoD) nke QuickVue SARS Antigen Test site na iji mmachi nke SARS-CoV-2 na-ekpo ọkụ (ZeptoMetrix 0810587CFHI). Ihe ZeptoMetrix bụ nkwadebe nke SARS-Related Coronavirus 2 (SARS-CoV-2), kewapụrụ USA-WA1/2020, nke agbanyere ọkụ na 65°C maka nkeji iri atọ. E wetara ihe a jụrụ oyi na ntinye nke 30 x1.15 TCID107/mL.
Emebere ọmụmụ ihe iji chọpụta QuickVue SARS Antigen Test LoD iji gosipụta nyocha mgbe ị na-eji swabs ozugbo. N'ime ọmụmụ ihe a, swab NP jiri ihe dị ka 50-µL nke nsị nje na saline fesa. Agbakwunyere swab spiked na QuickVue SARS Antigen Test Extract n'otu oge na swab NP nwere matriks NP. A na-ahazi swabs ndị ahụ n'otu oge dịka ntinye ngwugwu si dị.
Ekpebiri LoD na nzọụkwụ atọ - Nyochaa LoD
A na-eme mpịachi 10 nke nje na-ekpo ọkụ na-ekpo ọkụ na saline ma hazie ya maka ọmụmụ ihe ọ bụla dịka akọwara n'elu. A nwalere dilutions ndị a na ugboro atọ. Ntinye uche kacha ala na-egosipụta 3 nke 3 dị mma ka ahọpụtara maka nchọta oke LoD. Dabere na nnwale a, ntinye uche a họọrọ bụ TCID50 nke 1.51 x104.
Nchọta mpaghara LoD
A na-eme dilutions atọ (3) okpukpu abụọ nke 1.51 x104 ntinye na saline edozi maka ọmụmụ ihe dịka akọwara n'elu. A nwalere dilutions ndị a na ugboro atọ. Ntinye uche kacha ala na-egosipụta 3 nke 3 ziri ezi ka ahọpụtara maka nkwenye LoD. Dabere na nnwale a, ntinye uche a họọrọ bụ 7.57 x103.
Nkwenye LoD
A nwalere ntinye nke 7.57 x103 dilution ugboro iri abụọ (20). Iri abụọ (20) n'ime iri abụọ (20) rụpụtara dị mma. Dabere na nnwale a, akwadoro itinye uche dị ka TCID50 nke 7.57 x103.
Mmeghachi omume nyocha/mmekọrịta
A na-enyocha mmeghachi omume nyocha nke ọgwụ mgbochi monoclonal na-elekwasị anya SARS-CoV-2 na QuickVue SARS Antigen Test site na ụdị SAR-CoV-2 dị ugbu a (lee tebụl n'okpuru).
| 2019-nCoV Strain/kewapụ | Isi mmalite/Sample .dị | Ntinye uche |
| USA-WA1/2020 | ZeptoMetrix 0810587CFHI | 1.15 x107 TCID50/ml |
Cross-Reactivity
A na-enyocha mmeghachi omume mgbochi nke ọgwụ mgbochi monoclonal ejiri mee nchọpụta SARS-CoV-2 site na ịnwale ụdị microorganisms dị iche iche (12) na nje (16) nke nwere ike ịgafe nzaghachi na QuickVue SARS Antigen Test. A nwalere akụkụ ahụ na nje ọ bụla n'ime ugboro atọ. Edere mkpokọta ikpeazụ nke ihe ndị dị ndụ na nje na tebụl dị n'okpuru
| Cross-Reactivity/Mbichi nke QuickVue SARS Antigen Test | |||||
|
Nje Virus/Bacteria/Parasite |
eriri |
Isi mmalite/Sample
ụdị |
Ntinye uche |
Nsonaazụ mmeghari mmegharị* |
Nsonaazụ nnyonye anya* |
| Adenovirus ọrịa | Ụdị 1 | Kewapụ | 1 x105.53 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Coronavirus | 229e | Kewapụ | 1 x105.10 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Cross-Reactivity/Mbichi nke QuickVue SARS Antigen Test | |||||
|
Nje Virus/Bacteria/Parasite |
eriri |
Isi mmalite/Sample
ụdị |
Ntinye uche |
Nsonaazụ mmeghari mmegharị* |
Nsonaazụ nnyonye anya* |
| Coronavirus | OC43 | Kewapụ | 9.55 x105
TCID50/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Coronavirus | NL63 | Kewapụ | 5 x103.67 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| MERS-CoV (okpomọkụ anaghị arụ ọrụ) | Florida/USA- 2_Saudi
Arabia_2014 |
Kewapụ |
1.17 x105 TCID50/ml |
Enweghị Cross-Reactivity |
Enweghị nnyonye anya |
| Mycoplasma pneumonia | M129 | Kewapụ | 3 x106
CCU/ml** |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Streptococcus pyogenes | Z018 | Kewapụ | 3.8 x106
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Influenza A H3N2 | Brisbane/10/07 | Kewapụ | 1 x105.07 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Influenza A H1N1 | Ọhụrụ
Caledonia/20/99 |
Kewapụ | 1 x105.66 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Influenza B | Brisbane/33/08 | Kewapụ | 1 x105.15 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Parainfluenza | Ụdị 1 | Kewapụ | 1 x105.01 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Parainfluenza | Ụdị 2 | Kewapụ | 1 x105.34 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Parainfluenza | Ụdị 3 | Kewapụ | 8.5 x105
TCID50/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Parainfluenza | Ụdị 4b | Kewapụ | 1 x105.53 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Ọrịa enterovirus | Ụdị 68 | Kewapụ | 1 x105.5 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Mmadụ
Metapneumovirus |
A1 (IA10-s003) | Kewapụ | 1 x105.55 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Mmekọrịta iku ume
Nje |
Ụdị A (3/2015
Kewapụ #3) |
Kewapụ | 1 x105.62 Ọ/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Rhinovirus mmadụ | N/A | Agbanyụrụ arụ ọrụ
nje |
Ọ bụghị
dị *** |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Chlamydophila
ka oyi baa |
AR-39 | Kewapụ | 2.9 x106
IFU/ml**** |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Haemophilus influenzae | Ụdị b; Eagan | Kewapụ | 7.87 x106
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Legionella pneumophila | Philadelphia | Kewapụ | 6.82 x106
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Streptococcus
ka oyi baa |
Z022; 19 f | Kewapụ | 2.26 x106
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Bordetella pertussis | A639 | Kewapụ | 6.37 x106
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Pneumocystis jirovecii-S.
akụrụngwa Recombinant |
W303-Pji |
Kewapụ |
1.56 x106
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Mycobacterium
ụkwara nta |
H37Ra-1 | Kewapụ | 6.86 x107
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Staphylococcus
epidermis |
MRSE; RP62A | Kewapụ | 1.21 x1010
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Staphylococcus aureus
MSSA |
NCTC 8325 | Kewapụ | 5.5 x109
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Cross-Reactivity/Mbichi nke QuickVue SARS Antigen Test | |||||
|
Nje Virus/Bacteria/Parasite |
eriri |
Isi mmalite/Sample
ụdị |
Ntinye uche |
Nsonaazụ mmeghari mmegharị* |
Nsonaazụ nnyonye anya* |
| Staphylococcus aureus
MRSA |
0801638 | Kewapụ | 1.38 x1010
cfu/ml |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| A nwaleghị Coronavirus HKU1 maka mmeghachi omume cross-reactivity n'ihi enweghị nnweta. A nwalere ụdịdị 19 nwere Coronavirus HKU1 na ihe niile rụpụtara dị ka ihe na-adịghị mma, achọghị nyocha mmiri nke mmeghachi omume ọzọ. | |||||
- * E mere ule ugboro atọ
- ** CCU/ml bụ nkeji na-agbanwe agba dị ka agbakọrọ dabere na usoro Reed-Muench gbanwetụrụ dabere na dilutions nke mepụtara mgbanwe agba na efere.
- *** Ngwaahịa anaghị arụ ọrụ nje na-enweghị ọnụọgụ ọ bụla enyere.
- **** IFU/ml bụ nkeji na-efe efe kwa milliliter
Mmetụta nko
Dịka akụkụ nke ọmụmụ LoD, a nwalere mkpokọta kacha elu nke ngwaahịa SARS-CoV-2 anaghị arụ ọrụ (TCID50 nke 3.40 x105 kwa mL). Enweghị mmetụta nko ahụrụ.
Ọmụmụ ihe nnyonye anya endogenous
Emere ọmụmụ ihe iji gosi na ihe iri abụọ (20) nwere ike itinye aka nke enwere ike ịhụ na traktị iku ume elu anaghị emeghachi omume ma ọ bụ gbochie nchọpụta SARS-CoV-2 na QuickVue SARS Antigen Test.
| Ihe nwere ike itinye aka na QuickVue SARS Antigen Test | ||||
| Ihe | Ihe na-arụ ọrụ | Ntinye uche | Cross-Reactivity
Nsonaazụ* |
Ntinye aka
Nsonaazụ* |
| Afrin - imi imi | Oxymetazoline | 5% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Homeopathic (Alkalol) | Galphimia glauca, Luffa
operculate, Sabadilla |
10X | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Ọbara (mmadụ) | Ọbara | 5% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Chloraseptic, Cepacol | Benzocaine, Menthol | 0.7 g/mL | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| CVS akpịrị ịgba | Phenol | 1.4% | ||
| Flonase | Fluticasone | 5% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Ụlọ Nzukọ Relief Cherry
Atọ ụtọ |
Menthol | 0.8 g/mL | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Ude Mupirocin | Mupirocin | 2% w/w | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Nasacort Allergy 24
awa |
Triamcinolone | 5.00% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| NasalCrom fesa | Sodium nke Cromolyn | 5.2mg | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| NeilMed SinuFlow
Jikere kpochaa |
Sodium chloride, sodium
bicarbonate |
Ọ bụghị
dị** |
Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| NeilMed SinuFrin Plus | Oxymetazoline HCl | 0.05% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Neo-Synephrine | Phenylephrine
hydrochloride |
5% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Oseltamivir | Oseltamivir | 2.2 μg/ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Ihe nwere ike itinye aka na QuickVue SARS Antigen Test | ||||
| Protein mucin dị ọcha | Protein mucin | 2.5 mg / ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Rhinocort | Budesonide
Glucocorticosteroids (nke a na-akpọkarị) |
5% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Saline imi imi | Saline | 15% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Tobramycin | Tobramycin | 1.25 mg / ml | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Zanamivir | Zanamivir | 282.0ng/mL | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
| Ọgwụgwọ oyi nke Zicam | Galphimia glauca, Luffa
operculate, Sabadilla |
5% | Enweghị Cross-Reactivity | Enweghị nnyonye anya |
- * E mere ule ugboro atọ
- ** Enweghị ntinye uche na ntinye aha ngwaahịa
Enyemaka
Ọ bụrụ na ị nwere ajụjụ ọ bụla gbasara iji ngwaahịa a, biko kpọọ Quidel's Technical Support Number 800.874.1517 (na US) ma ọ bụ 858.552.1100, Mọnde ruo Fraịde, site na 7:00 ụtụtụ ruo 5:00 ehihie, Oge Pacific. Ọ bụrụ na mpụga US, kpọtụrụ onye nkesa mpaghara ma ọ bụ technicalsupport@quidel.com. Enwere ike kọọrọ FDA nsogbu sistemu ule site na mmemme mkpesa ngwaahịa ọgwụ MedWatch (ekwentị:
800.FDA.1088; faksị: 800.FDA.0178; http://www.fda.gov/medwatch).
Ntụaka
- Baker, S., Frias, L., na Bendix, A. Mmelite ndụ Coronavirus: Ihe karịrị mmadụ 92,000 ebutela ọrịa yana opekata mpe 3,100 anwụọla. US akọpụtala ọnwụ 6. Nke a bụ ihe niile anyị maara. Business Insider. Maachị 03, 2020.
- https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
- Clinical na Laboratory Standards Institute. Omenala malitere ịrịa; Ntuziaka akwadoro. Akwụkwọ CLSI M41-A [ISBN 1562386239] Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2006.
- Lauer, SA, et. al. Oge nnabata nke ọrịa Coronavirus 2019 (COVID-19) sitere na ikpe ndị akwadoro n'ihu ọha: atụmatụ na ngwa, Ann Intern Med. 2020
- Biosafety na Laboratories Microbiological na Biomedical, Mbipụta nke ise. Ngalaba Ahụike na Ọrụ Ndị Ọrụ US, CDC, NIH, Washington, DC (5).
- Henretig FM MD, Eze C. MD. Akwụkwọ ọgụgụ nke usoro ụmụaka, isi nke 123 - Inweta ihe nleba anya n'ihe gbasara ndụ ndụ Williams na Williams (Eprel 1997).
- The Clinical Virology Laboratory, Department of Laboratory Medicine na Yale: http://info.med.yale.edu/labmed/virology/booklet.html.
- Atụmatụ nchịkwa Australia maka influenza na-efe efe - Nkebi nke 5 Agbakwunyere 5: Ntuziaka ụlọ nyocha.
Akwụkwọ / akụrụngwa
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