Cikakken Bayani

Amfani da Niyya
LYHER® COVID Gwajin shine don ganowa kai tsaye da inganci na antigen na SARS - CoV - 2 da mura A/B daga ɓoyewar hanci da ɓoye na oropharyngeal. Kit ɗin shine don amfani da bincike na in vitro.

Game da COVID-19
COVID-19 cuta ce mai saurin kamuwa da numfashi. Mutane gabaɗaya suna da sauƙi. A halin yanzu, marasa lafiya da suka kamu da cutar sankara ta coronavirus sune babban tushen kamuwa da cuta; Mutanen da suka kamu da asymptomatic suma suna iya zama tushen kamuwa da cuta. Dangane da binciken cututtukan cututtuka na yanzu, lokacin shiryawa shine kwanaki 1 zuwa 14, galibi daga kwanaki 3 zuwa 7. Babban bayyanar cututtuka sun haɗa da zazzabi, gajiya da bushewar tari. Ana samun cunkoso na hanci, hanci, ciwon makogwaro, myalgia da gudawa a wasu lokuta.

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Kit ɗin ya ƙunshi

Bayani dalla-dalla: 25 T/kit
1) SARS - CoV - 2 antigen gwajin Cassette
2) Bututu mai cirewa tare da maganin cirewar samfurin da tip
3) Auduga swab
4) IFU: 1 guda/kit
5) Tubu tsayawa: 1 yanki/kit
Ƙarin kayan da ake buƙata: agogo/ mai ƙidayar lokaci/ agogon gudu
Lura: Kada a haɗa ko musanya nau'ikan kits daban-daban.

Ƙayyadaddun bayanai

Gwajin Abun Misali Nau'in Yanayin Ajiya
antigen na SARS - CoV - 2 da mura A/B Nasopharyngeal swab/oropharyngeal swab 2-30
Hanya Lokacin Gwaji Rayuwar Rayuwa
Colloidal Gold 15 min watanni 24

Aiki

Tarin Samfura da Ajiye

1.Wannan samfurin za a iya amfani dashi don nasopharyngeal ko oropharyngeal swab samfurori. Nasopharyngeal swab samfurori ana bada shawarar sosai.
2.Za a ɗauki matakan kariya lokacin tattara samfuran kuma za a tattara samfuran daidai da dabarun tattara lasisi.
3.Kafin tattara samfuran, tabbatar da cewa an rufe bututun samfurin kuma buffer ɗin cirewa baya zubowa. Sa'an nan kuma yayyage hatimin cire bututun da aka riga aka cika da buffer kuma a hankali sanya shi a kan madaidaicin bututu.
4.Tarin Samfura:
Samfurin Oropharyngeal: Da kan majiyyaci ya dan dago sama, kuma a bude baki, tonsils na majiyyaci ya fito fili. Tare da swab mai tsabta, ana shafa tonsils na majiyyaci a hankali a hankali a baya da baya akalla sau 3, sannan a shafa bangon pharyngeal na baya da baya a kalla sau 3.
Samfurin Nasopharyngeal: Bari kan mara lafiya ya huta a hankali. Juya swab zuwa bangon hanci a hankali a cikin hanci, zuwa ga baki, sannan a juya yayin shafa kuma cire a hankali.
Maganin Samfurin: Saka kan swab a cikin buffer cirewa bayan an gama tattara samfurin, a gauraya da kyau, a matse swab sau 10-15 ta hanyar matsa bangon bututun a kan swab, sannan a bar shi ya tsaya na minti 1 don adana samfurori da yawa kamar mai yiwuwa a cikin ma'aunin hakar samfur. Yi watsi da swab.
5.Ya kamata a gwada samfuran Swab da wuri-wuri bayan tattarawa. Yi amfani da sabbin samfuran da aka tattara don mafi kyawun aikin gwaji.
6.Idan ba a gwada shi nan da nan ba, za'a iya adana samfuran swab tsakanin 2-8°C na tsawon awanni 4 bayan tattarawa ko kuma a adana su a zafin jiki na awa 1. Idan ana buƙatar ajiya na dogon lokaci, ya kamata a ajiye shi a - 70 ℃ don guje wa maimaita daskarewa- narkewar hawan keke.
7.Kada a yi amfani da samfuran da babu shakka sun gurɓace da jini, saboda yana iya tsoma baki tare da kwararar samfurin tare da fassarar sakamakon gwaji.

Tsarin Gwaji

1.Shirya
1.1 Samfuran da za a gwada da abubuwan da ake buƙata za a cire su daga yanayin ajiya kuma a daidaita su zuwa zafin jiki;
1.2 Za a cire kit ɗin daga jakar marufi kuma a ajiye shi a kan busasshen benci.

2. Gwaji
2.1 Sanya kayan gwajin a kwance akan tebur.
2.2 Ƙara samfuri
Sanya tip mai tsabta mai tsabta akan bututun samfurin kuma juya bututun samfurin don ya kasance daidai da samfurin rijiyar (S) kuma ƙara digo 3 (kimanin 100 μl) na samfurin ga kowane samfurin rijiyar (S). Saita lokaci na minti 15.
2.3 Karanta sakamakon
Za a iya gano ingantattun samfuran a cikin mintuna 15 bayan ƙara samfurin.

Tafsirin Sakamako

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KYAU:Layuka masu launi biyu suna bayyana akan membrane. Layi ɗaya yana bayyana a yankin sarrafawa (C) kuma ɗayan layin yana bayyana a cikin gwajin
MARA:Layi mai launi ɗaya kawai ya bayyana a cikin yankin sarrafawa (C). Babu wani layi mai launi da ya bayyana a yankin gwaji (T).
RA'AYI:Layin sarrafawa ya kasa bayyana.
Don mura A/B

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mura A KYAU:Yana da inganci ga mura A antigen idan jajayen layi biyu sun bayyana. Layin ja ɗaya yakamata ya kasance a cikin yankin layin sarrafawa (C), ɗayan kuma yana bayyana a yankin layin gwajin A.
mura B KYAU:Yana da inganci ga rigakafin mura B idan layukan ja guda biyu sun bayyana. Layi ja ɗaya yakamata ya kasance a cikin yankin layin sarrafawa (C), ɗayan kuma yana bayyana a yankin layin gwajin B.
mura A da B KYAU:Yana da inganci ga duka antigens na mura A da mura B idan layukan ja guda uku sun bayyana. Layin ja ɗaya yakamata ya kasance a cikin yankin layin sarrafawa (C), kuma wani biyu kuma yakamata ya bayyana a yankin layin gwajin A da yankin layin gwajin B.
MARA:Layi ja ɗaya yana bayyana a yankin sarrafawa (C). Babu jajayen layin da ya bayyana a yankin gwajin mura A da B (T).

Ayyukan Clinical

Table 1-1: Kayan Gwajin Lyher - COVID-19

Hankali: 96.23% Takamaiman: 100% Daidaici: 98.96%

Table 1-2: Kayan Gwajin Lyher - mura A

Hankali: 100% Takamammen bayani: 100% Saidai: 100%

Table 1-3: Kayan Gwajin Lyher - Inluenza B

Hankali: 94.44% Takamaiman: 100% daidai: 99.48%