Gwajin sauri na SARS-CoV-2 Antigen (Hanci)
Samfurin yana da keɓaɓɓen wakili a cikin New Zealand.Idan kuna sha'awar siya, bayanin lamba kamar haka:
Mick Dienhoff
Ganaral manaja
Lambar waya: 0755564763
Lambar wayar hannu: 0492 009 534
E-mail: enquiries@nzrapidtests.co.nz
AMFANI DA NUFIN
StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette yana amfani da fasahar immunochromatography don gano antigen SARS-CoV-2 nucleocapsid a cikin samfurin hancin hanci na gaban mutum.Wannan gwajin amfani guda ɗaya ne kawai kuma an yi nufin gwada kansa.An ba da shawarar yin amfani da wannan gwajin a cikin kwanaki 5 na bayyanar cututtuka.Ana goyan bayan aikin kima na asibiti.
GABATARWA
Novel coronaviruses na totiie p genus ne.COVID-19 cuta ce mai saurin kamuwa da numfashi.Mutane gabaɗaya suna da sauƙi.A halin yanzu, marasa lafiya da suka kamu da labari cxjronavinis sune babban tushen kamuwa da cuta;Mutanen da suka kamu da asymptomatic suma suna iya zama tushen kamuwa da cuta.Dangane da binciken 1 da ya yi a halin yanzu na cututtukan cututtuka, lokacin shiryawa shine kwanaki 1 zuwa 14, yawanci kwanaki 3 zuwa 7.Babban bayyanar cututtuka sun haɗa da zazzabi, gajiya da bushewar tari.Ana samun cunkoso na hanci, yawan gudu, ciwon makogwaro, myalgia da gudawa a wasu lokuta.
KA'IDA
Gwajin Antigen StrongStep® SARS-CoV-2 yana amfani da gwajin immunochromatographic.Latex conjugated antibodies (Latex-Ab) daidai da SARS-CoV-2 ana bushe-bushe a ƙarshen tsiri nitrocellulose.Kwayoyin rigakafin SARS-CoV-2 suna da alaƙa a Yankin Gwaji (T) kuma Biotin-BSA haɗin gwiwa ne a Yankin Sarrafa (C).Lokacin da aka ƙara samfurin, yana yin ƙaura ta hanyar watsawar capillary yana mai da ruwa mai haɗuwa da latex.Idan akwai a cikin samfurin, SARS-CoV-2 antigens za su ɗaure tare da ƙwayoyin rigakafi masu haɗuwa da ke haifar da barbashi.Waɗannan barbashi za su ci gaba da yin ƙaura tare da tsiri har zuwa Yankin Gwaji (T) inda ƙwayoyin rigakafin SARS-CoV-2 suka kama su suna haifar da layin ja mai gani.Idan babu antigens SARS-CoV-2 a cikin samfur, ba a samar da layin ja a cikin Yankin Gwaji (T).Ƙungiyar streptavidin za ta ci gaba da yin ƙaura shi kaɗai har sai an kama shi a cikin Sarrafa Sarrafa (C) ta hanyar Biotin-BSA ta tara a cikin layin shuɗi, wanda ke nuna ingancin gwajin.
KIT ABUBUWAN
1 gwaji/akwati; 5 gwaje-gwaje/akwati:
Rufe jakar jaka cike da na'urorin gwaji | Kowace na'ura tana ƙunshe da tsiri mai launin conjugates da reactive reagents waɗanda aka riga aka watsa a yankuna masu dacewa. |
Dilution Buffer vials | 0.1 M Phosphate buffered saline (PBS) da 0.02% sodium azide. |
Bututun cirewa | Don samfuran shirye-shiryen amfani. |
Fakitin swab | Don tarin samfurin. |
Wurin aiki | Wuri don riƙe buffer vials da bututu. |
Saka kunshin | Don umarnin aiki. |
20 gwaje-gwaje/akwati
20 na'urorin gwaji cike da ɗaiɗaikun | Kowace na'ura tana ƙunshe da tsiri mai launin conjugates da reactive reagents waɗanda aka riga aka watsa a cikin abubuwan da suka dace. |
2 Filayen Buffer Extraction | 0.1 M Phosphate buffered saline (P8S) da 0.02% sodium azide. |
20 Bututun cirewa | Don samfuran shirye-shiryen amfani. |
1 Wurin aiki | Wuri don riƙe buffer vials da bututu. |
1 Kunshin saka | Don umarnin aiki. |
KAYAN DA AKE BUKATA AMMA BA'A SAMU BA
Mai ƙidayar lokaci | Don amfani da lokaci. |
Duk wani muhimmin kayan kariya na sirri |
MATAKAN KARIYA
-Wannan kayan aikin na IN VITRO ne kawai don amfani da bincike.
- Karanta umarnin a hankali kafin yin gwajin.
- Wannan samfurin bai ƙunshi kowane kayan tushen ɗan adam ba.
-Kada a yi amfani da abun ciki na kit bayan ranar karewa.
Saka safofin hannu yayin duk aikin.
AJIYA DA KWANTA
Za a iya adana buhunan da aka rufe a cikin kayan gwajin tsakanin 2-30 C na tsawon rayuwar shiryayye kamar yadda aka nuna akan jakar.
TATTAUNAWA DA MISALIN
Ana iya tattara samfurin swab na hanci na gaba ko kuma ta hanyar wani mutum ɗaya ya yi amfani da swab ɗin kai.
Yaran da ba su kai shekara 18 ba, ya kamata a yi su ta hanyar kulawar aduK.Manya masu shekaru 18 zuwa sama suna iya yin swab na gaba da kansu.Da fatan za a bi ƙa'idodin gida don tattara samfuran yara.
, Saka swab ɗaya a cikin hanci ɗaya na majiyyaci.Ya kamata a saka titin swab har zuwa 2.5 cm (inch 1) daga gefen hanci.Mirgine swab sau 5 tare da mucosa a cikin hanci don tabbatar da cewa an tattara gabobin ciki da sel.
Yi amfani da swab iri ɗaya, maimaita wannan tsari don tha sauran hanci don tabbatar da cewa an tattara isasshen samfurin daga kogon hanci guda biyu.
Ana ba da shawarar cewa samfuran su kasancesarrafada wuri-wuri bayan tarin.Za'a iya ɗaukar samfurori a cikin kwantena har zuwa awanni a zafin jiki na inna (15 ° C zuwa 30 "C), ko har zuwa awanni 24 lokacin da rsfrigeratod (2°C zuwa 8)eC) kafin aiwatarwa.
TSARI
Kawo na'urorin gwaji, samfura, buffer da/ko sarrafawa zuwa zafin ɗaki (15-30°C) kafin amfani.
♦Sanya bututun da aka tattara a cikin wurin da aka keɓe na wurin aiki.
♦Matse duk abin da ake buƙata na Dilution a cikin bututun rediyon ext.
♦Saka swab na samfurin a cikin bututu.Haxa maganin da ƙarfi ta hanyar jujjuya swab da ƙarfi a gefen bututun na tsawon aƙalla sau 15 (yayin nutsewa).Ana samun sakamako mafi kyau lokacin da samfurin ya haɗu da ƙarfi a cikin maganin.
♦Bada swab ya jiƙa a cikin Maɓallin Ciro na tsawon minti ɗaya kafin mataki na gaba.
♦Fitar da ruwa mai yawa kamar yadda zai yiwu daga swab ta hanyar danna gefen bututun hakar mai sassauƙa yayin da ake cire swab.Aƙalla 1/2oftie bayani na buffer dole ne ya kasance a cikin bututu don isassun ƙaura na capillary ya faru.Saka hular kan abin da aka fitar.
♦Yi watsi da swab a cikin kwandon shara mai haɗari mai haɗari.
♦Samfuran da aka fitar na iya riƙewa a zafin jiki na tsawon mintuna 30 ba tare da shafar sakamakon gwajin ba.
♦Cire wannan na'urar gwajin daga jakarta da aka hatimi, sa'annan ka sanya ta a kan wani ma'auni, matakin matakin.Yi wa na'urar lakabi da majiyyaci ko ganewar sarrafawa.Don samun sakamako mafi kyau, yakamata a yi gwajin a cikin mintuna 30.
♦Ƙara ɗigo 3 (kimanin 100 pL) na samfurin da aka fitar daga Tube Extraction zuwa samfurin zagaye da kyau akan na'urar gwaji.
Guji kama kumfa mai iska A cikin rijiyar samfurin (S), kuma kar a sauke kowane bayani A cikin taga kallo.Yayin da gwajin ya fara aiki, za ku ga launi yana motsawa a cikin membrane.
♦Wart don band(s) masu launi su bayyana.Ya kamata a karanta sakamakon ta gani a cikin mintuna 15.Kar a fassara sakamakon bayan mintuna 30.
•Saka bututun gwajin da ke dauke da swab da na'urar gwajin da aka yi amfani da ita cikin jakar kwayar halitta da aka makala sannan a rufe ta, sannan a jefar da shi a cikin kwandon shara mai dacewa.Sannan jefar da sauran Abubuwan
•Wankahannunka ko sake shafa hannun sanitizer.
Yi watsi da Bututun Ciro da Na'urorin Gwaji da aka yi amfani da su a cikin kwandon shara mai dacewa.
IYAKA NA GWAJI
1- Kit ɗin an yi nufin amfani dashi don gano ingantattun antigens na SARS-CoV-2 daga hanci.
2.Wannan gwajin yana gano duka mai yiwuwa (rayuwa) da SARS-CoV-2 mara amfani.Gwajin gwajin ya dogara da adadin ƙwayoyin cuta (antigen) a cikin samfurin kuma yana iya ko a'a ya daidaita da sakamakon al'adun hoto ko bidiyo mai zagaya yanar gizo da sauri.
3.Sakamako mara kyau na teat zai iya faruwa idan matakin antigen a cikin samfurin yana ƙasa da iyakar ganowa na gwajin ko kuma idan an tattara samfurin ko kuma ɗaukar samfurin ba daidai ba.
4.Rashin bin Tsarin Gwajin na iya yin illa ga aikin gwaji da/ko ɓata sakamakon gwajin.
5. Dole ne a haɗa sakamakon gwajin gwaji tare da tarihin asibiti, bayanan cututtuka, da sauran bayanan da ke samuwa ga likitancin da ke kimanta mai haƙuri.
6.Sakamakon gwaji mai kyau ba ya kawar da kamuwa da cuta tare da sauran cututtuka.
7.Ba a nufin sakamakon gwaji mara kyau don yin hukunci a cikin wasu cututtukan da ba na SARS ko ƙwayoyin cuta ba.
8.Sakamako mara kyau daga marasa lafiya tare da alamun bayyanar da suka wuce bayan kwanaki bakwai, ya kamata a bi da su kamar yadda ake tsammani kuma an tabbatar da su tare da FDA na gida da aka ba da izini na kwayoyin halitta, idan ya cancanta, don kulawa da asibiti, ciki har da kulawar kamuwa da cuta.
Shawarwari na kwanciyar hankali na misalan sun dogara ne akan bayanan kwanciyar hankali daga gwajin mura da aiki na iya bambanta da SARS-CoV-2.Masu amfani yakamata su gwada samfuran da sauri bayan tarin samfurin.
10. Hankali don tantancewar RT-PCR a cikin ganewar asali na COVID-19 shine kawai 50% -80% saboda rashin ingancin samfurin ko lokacin lokacin cuta a lokacin da aka dawo dashi, da sauransu.SARS-CoV-2 Antigen Rapid Test Na'urar Hannun Hannun Na'urar shine a ka'ida. kasa saboda hanyarsa.
11.Don samun isasshen ƙwayar cuta, ana ba da shawarar yin amfani da swabs biyu ko fiye don tattara wurare daban-daban na samfurin kuma cire duk swab ɗin da aka ɗauka a cikin bututu ɗaya.
12.Kyakkyawan dabi'un tsinkaya mara kyau da mara kyau sun dogara sosai akan yawan adadin.
13.Kyakkyawan sakamako na gwaji suna iya wakiltar sakamako mai kyau na karya yayin lokutan kadan na ba aikin SARS-CoV-2 lokacin da yaduwar cutar ta ragu. babba.
14.Monoclonal rigakafi na iya kasa ganowa, ko gano tare da ƙarancin hankali, ƙwayoyin cuta na SARS-CoV-2 waɗanda suka sami ƙananan canje-canjen amino acid a cikin yankin epitope da aka yi niyya.
15.Ba a kimanta aikin wannan gwajin don amfani da marasa lafiya ba tare da alamu da alamun kamuwa da cututtukan numfashi da parformance na iya bambanta a cikin mutane masu asymptomatic.
16.Yawan antigen A cikin samfurin na iya raguwa yayin da tsawon lokacin rashin lafiya ya karu.Samfuran da aka tattara bayan rana ta 5 na rashin lafiya sun fi zama mara kyau idan aka kwatanta da gwajin RT-PCR.
17.Sensitivity na gwajin bayan kwanaki biyar na farko na farkon bayyanar cututtuka an nuna su raguwa kamar yadda aka kwatanta da gwajin RT-PCR.
18.An ba da shawarar yin amfani da StrongStep® SARS-CoV-2 IgM/IgG antibody fast gwajin (caW 502090) don gano maganin rigakafi don haɓaka haƙarƙarin gano cutar COVID-19.
19.Ba a ba da shawarar yin amfani da samfurin Transport Transport medla(VTM) A cikin wannan gwajin, Idan abokan ciniki sun nace don amfani da wannan nau'in samfurin, abokan ciniki yakamata su inganta kansu.
20.The StrongStep® SARS-CoV-2 Antigen Rapid Test an inganta shi tare da swabs da aka bayar a cikin kit.Amfani da madadin swabs na iya haifar da sakamako na ƙarya.
21.Yin gwaji akai-akai ya zama dole don ƙara azancin kamuwa da cutar ta COVID-19.
22.Ba a sauke a hankali idan aka kwatanta da nau'in daji tare da rasped zuwa bambance-bambancen masu zuwa - VOC1 Kent, UK, B.1.1.7 da VOC2 Afirka ta Kudu, B.1.351.
23 Ka kiyaye nesa da yara.
24. Sakamako mai kyau yana nuna cewa an gano antigens na kwayar cuta a cikin samfurin da aka ɗauka, don Allah a keɓe kai kuma sanar da likitan dangi da sauri.
Nanjing Liming Bio-Products Co., Ltd.
No. 12 Huayuan Road, Nanjing, Jiangsu, 210042 PR China.
Lambar waya: +86 (25) 85288506
Fax: (0086) 25 85476387
Imel:sales@limingbio.com
Yanar Gizo: www.limingbio.com
Technical support: poct_tech@limingbio.com
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