InnoScreen SCOV-23-H002 COVID-19 Antigen Rapid Test Device Manual

Muyenera kutsatira malangizo a mayeso mosamala kuti mupeze zotsatira zolondola. Mayeso othamanga a antigen sakhala odalirika kwambiri kuposa PCR poyesa wodwala wopanda zizindikiro kapena woyezetsa pambuyo pa masiku 7 akuyamba chizindikiro chifukwa atha kutulutsa zotsatira zabodza. Osagwiritsa ntchito mayeso kwa mwana wosakwana zaka ziwiri. Kwa ana azaka 2-2, mayesowo ayenera kuchitidwa ndi munthu wamkulu. Kwa in vitro diagnostic ntchito kokha.

CHOFUNIKA: Kugwetsa mphuno ndizovuta. Ngati simukugwedeza mphuno, chipangizocho chidzatulutsa zotsatira zabodza.

MMENE MUNGACHITE MAYESO

Tsatirani sitepe iliyonse motsatana ndi manambala

Zida zoperekedwa:

Single ntchito swab

Kaseti yoyesera
M'zigawo chubu

Chikwama cha zinyalala

Mudzafunikanso:

Matupi
Nthawi/wotchi

Tsegulani zigawo zoyesera.MUSATAYE bokosilo. Onetsetsani kuti muli ndi zigawo zonse zofunika. OSAGWIRITSA NTCHITO ngati zatha kapena kuwonongeka.
Kaseti Yoyesera

Nsapato

M'zigawo chubu

Chikwama cha Zinyalala
Pang'onopang'ono imbani mphuno yanu mu minofu kuti muchotse ntchofu zambiri. Sambani m'manja ndi sopo ndi madzi kwa masekondi osachepera 20 kapena gwiritsani ntchito sanitizer.

Chotsani kaseti yoyesera m'thumba ndikuyiyika pamalo athyathyathya, aukhondo. MUSAKHUDZA zenera loyesera.
Ikani chubu chochotsa mu dzenje pabokosi.

Chotsani kapu yabuluu. Sungani kapu pambali, OSATAYA.

Tsegulani swab kuchokera kumapeto kolembedwa "PEEL APA" ndikuchotsa swab. OSAKHUDZA nsonga ya swab.
Ikani swab pang'onopang'ono pafupifupi 1-2cm mumphuno YAKUDALIRA, ndikusisita ku khoma lamphuno mozungulira mozungulira kwa osachepera kasanu kwa masekondi 5. Chotsani swab ndikubwereza ndondomekoyi ndi LEFT mphuno.

Ikani swab mu chubu chochotsa.
Chotsani chogwirira cha swab pamalo opuma. Tayani chogwirira chopuma.
Bwezerani chipewa cha buluu pa chubu. Finyani kumunsi kwa chubu ndi swab nsonga mkati mwa chubu nthawi 15.

Chotsani chipewa choyera cha chubu. Pindutsani chubu ndikufinyani chubu mofatsa kuti muwonjezere madontho atatu a yankho ku sampndi zolembedwa bwino “S” pa kaseti.
Yambitsani nthawi ndikuwerenga zotsatira pa mphindi 15 molingana ndi gawo la KUTANTHAUZIRA ZOPHUNZITSA patsamba lino.
Zotsatira siziyenera kuwerengedwa patadutsa mphindi 20.

Mukawerenga zotsatira zake, ikani zonse zomwe zagwiritsidwa ntchito mu thumba la pulasitiki loperekedwa ndikutaya mu nkhokwe ya zinyalala.

KUMASULIRA ZOTSATIRA

POSITIVE (Mizere iwiri yamitundu yowoneka bwino m'chigawo chowongolera ndi dera loyesa)

Kuchuluka kwa mtundu m'chigawo choyesera "T" kungakhale kofooka. Mzere uliwonse wapinki/wofiirira womwe ukuwoneka pafupi ndi “T” ndi wabwino. Zotsatira zabwino ziyenera kutsimikiziridwa ndi kuyesa kwa PCR kwa chisamaliro chotsatira chachipatala.

Zotsatira zoyeserera za COVID-19 zikuwonetsa kuti ma antigen ochokera ku SARS-CoV-2 adapezeka, ndipo wodwalayo atha kutenga kachilomboka ndikuwoneka kuti ndi wodwalatagizi. Zotsatira zoyezetsa ziyenera kuganiziridwa nthawi zonse pokhudzana ndi zochitika zachipatala ndi deta ya epidemiological (monga kuchuluka kwa kufalikira kwanuko ndi malo omwe akuphulika / malo omwe ali pachiopsezo) popanga matenda omaliza ndi zisankho zosamalira odwala.
Oyang'anira odwala ayenera kutsatira zomwe dipatimenti ya zaumoyo ikuwongolera.

NEGATIVE (Mzere wachikuda umodzi wokha ukuwoneka m'chigawo chowongolera)

Zotsatira zoyipa za mayesowa zikutanthauza kuti ma antigen ochokera ku SARS-CoV-2 sanapezeke pachitsanzo chopitilira malire odziwika. Ndizotheka kuti kuyezetsaku kupereke zotsatira zomwe zili zolakwika (zabodza) mwa anthu ena omwe ali ndi COVID-19 makamaka ngati kuyezetsa sikunachitike mkati mwa masiku 7 chiyambireni zizindikiro.
Izi zikutanthauza kuti mutha kukhalabe ndi COVID-19 ngakhale mayeso alibe. Ngati mupezeka kuti mulibe kachilombo ndikupitilizabe kukhala ndi COVID-19 ngati zizindikiro za kutentha thupi, chifuwa komanso/kapena kupuma movutikira muyenera kupeza chithandizo chotsatira ndi dokotala wanu. Ngati mukukayikitsa ndipo mulibe chizindikiro, bwerezani zoyesererazo pakatha masiku 1-2, chifukwa coronavirus siyingadziwike molondola magawo onse a matenda.

MAYESO OSAVUTA (Palibe mzere wachikuda ukuwonekera m'chigawo chowongolera)

Chotsatira chosavomerezeka chimayamba chifukwa chosatsata ndondomekoyi moyenera. Werengani malangizo oti mugwiritse ntchito mosamala musanayambitsenso ndi chida chatsopano choyesera. Vuto likapitilira, funsani thandizo laukadaulo.

Kuti mupeze chithandizo chapafupi kuchokera ku dipatimenti ya zaumoyo m'boma ndi chigawo, onani zambiri mu gawo la chithandizo chakumbuyo >>>

NTCHITO YOTSATIRA

InnoScreen COVID-19 Antigen Rapid Test Device (Self-test) ndi njira yofulumira yoyendera ma immunoassay yomwe cholinga chake ndi kuzindikira ma antigen a SARS-CoV-2 nucleocapsid apuloteni kuchokera kwa anthu omwe ali ndi kapena opanda zizindikiro omwe akukayikira kuti ali ndi kachilombo ka COVID-19. Kuyezetsa uku ndikololedwa kugwiritsa ntchito kunyumba popanda mankhwala kwa anthu azaka 2 kapena kupitilira apo omwe akuwaganizira kuti ali ndi COVID-19 ndi achipatala m'malo omwe si a labotale. Ngati mayesowa akugwiritsidwa ntchito poyesa anthu opanda zizindikiro kapena zifukwa zina za miliri zokayikira kuti ali ndi COVID-19, kuyezetsa kuyenera kukonzedwa kawiri kupitilira masiku awiri (kapena atatu) ndi maola osachepera 24 (ndi osapitilira maola 36) pakati pa mayeso.

MAU OYAMBA

COVID-19 ndi matenda okhudzana ndi SARS-CoV-2, omwe adadziwika koyamba ku China kumapeto kwa 2019. Kachilomboka kamafalikira makamaka kudzera m'malovu opumira omwe anthu amayetsemula, kutsokomola, kapena kutulutsa mpweya. Nthawi yobereketsa ya COVID-19 ikuyembekezeka pakati pa masiku awiri mpaka 2.
Zizindikiro zodziwika bwino za matenda a COVID-19 ndi kutentha thupi, chifuwa komanso kupuma movutikira monga kupuma movutikira komanso kupuma movutikira.
Milandu yowopsa kwambiri imakhala ndi chibayo chachikulu, matenda opumira kwambiri, sepsis ndi septic shock zomwe zingayambitse imfa ya wodwalayo.
Anthu omwe ali ndi vuto losatha akuwoneka kuti ali pachiwopsezo chodwala kwambiri.

MUTU

InnoScreen COVID-19 Antigen Rapid Test Device ndi immunochromatographic membrane assay yomwe imagwiritsa ntchito ma antibodies a monoclonal kuti azindikire ma SARS-CoV-2 ma virus nucleoprotein antigens mu mphuno.

KUSAMALITSA

Kugwiritsa ntchito mavitamini pokhapokha.
Werengani Phukusi Insert musanagwiritse ntchito. Malangizo ayenera kuwerengedwa ndikutsatiridwa mosamala.
Ana kapena achinyamata azaka zapakati pa 2 mpaka 15 ayenera kukhala ndi sampzosonkhanitsidwa ndikuyesedwa ndi munthu wamkulu. Osagwiritsa ntchito mayesowa kwa aliyense wosakwana zaka ziwiri.
Osagwiritsa ntchito aliyense amene amakonda kutuluka magazi m'mphuno kapena amene wavulala kumaso kapena mutu/opaleshoni m'miyezi isanu ndi umodzi yapitayo.
Valani chigoba chotetezera kapena zophimba kumaso pamene mukutolera chitsanzo cha mwana kapena munthu wina.
Sungani zida zoyesera kutali ndi ana ndi ziweto musanazigwiritse ntchito.
Osagwiritsa ntchito zida kapena zida zomwe zidadutsa tsiku lotha ntchito.
Osayesa mayeso anu kunja kwa zosungira.
Zipangizo zoyesera zimapakidwa m'matumba a zojambula zomwe sizimapatula chinyezi panthawi yosungira. Siyani chipangizo choyesera muthumba lomata mpaka musanagwiritse ntchito.
Osagwiritsa ntchito chipangizo choyesera ngati thumba lawonongeka kapena lotseguka.
Zigawo zonse za kit ndizogwiritsidwa ntchito kamodzi. Osagwiritsa ntchito ndi zitsanzo zingapo. Osagwiritsanso ntchito zida zomwe zidagwiritsidwa ntchito.
Osasakaniza zinthu zosiyanasiyana.
Osagwira nsonga ya swab pogwira swab sample.
Chitani mayeso mukangotenga sample.

Magazi ochulukirapo kapena ntchofu pachitsanzo cha swab amatha kusokoneza momwe mayeso akuyendera ndipo atha kutulutsa zotsatira zabodza. Pewani kukhudza madera akukha magazi a m'mphuno potola zitsanzo.
Posonkhanitsa mphuno yamphongo sample, gwiritsani ntchito Nasal Swab yokhayo yomwe yaperekedwa mu kit.
Sungani zinthu zakunja ndi zinthu zoyeretsera m'nyumba kutali ndi mayeso panthawi yoyeserera. Kukhudzana ndi zinthu zakunja ndi zoyeretsera m'nyumba kungapangitse zotsatira zolakwika.

Gwiritsani ntchito zodzitetezera pakusonkhanitsa, kusamalira, kusunga, ndi kutaya odwala samples ndi zida zogwiritsa ntchito.
Gwiritsani ntchito zitsanzo zonse ngati kuti zili ndi mankhwala opatsirana.
Osagwiritsa ntchito m'zigawo zotchinga ngati ndi discolored kapena turbid.

Pewani kukhudzana ndi khungu chifukwa lili ndi kuchuluka kwa sodium azide. Njira yothetsera buffer siyenera kulowetsedwa.
Sungani chipangizo choyesera pamalo ophwanyika panthawi yoyesera.
Osatanthauzira zotsatira za mayeso pasanathe mphindi 15 komanso pakatha mphindi 20 mutayamba mayeso.

Tayani zida zomwe zagwiritsidwa ntchito ndi odwala samples mu zinyalala zapakhomo.
ZOTSATIRA ZOSAVUTA zitha kuchitika ngati kuchuluka kosakwanira kwa reagent yochotsa kuwonjezeredwa pakhadi yoyesera. Kuti mutsimikizire kutulutsa kokwanira, gwirani vial molunjika, 1 cm pamwamba pa sample bwino, ndi kuwonjezera madontho pang'onopang'ono.

KUSUNGA NDI Kukhazikika

Sungani chipangizo cha InnoScreen COVID-19 Antigen Rapid Test pa 2-30°C.

MUSAMASIMBITSE.
Zomwe zili m'kati mwa zida ndizokhazikika mpaka masiku otsiriza omwe alembedwa pamapaketi awo akunja ndi zotengera. Akatsegula chipangizocho chiyenera kugwiritsidwa ntchito nthawi yomweyo.

ZOYANG'ANIRA ZOSANGALALA PA MVULA REAGENT

Dzina la Mankhwala / CAS	GHS Code pazosakaniza zilizonse	ndende
Sodium azide / 26628-22-8	Acute Tox. 2 (Oral), H300 Acute Tox. 1 (Dermal), H310	<0.02%

ZOPEZA AMAYESA

Zotsatira zoyipa sizimaletsa SARS-CoV-2 ndi / kapena mitundu ina yamatenda a virus, makamaka mwa omwe adakumana ndi kachilomboka kapena ali ndi zizindikiro. Kuyesedwa kotsatira ndi mayeso otsimikizira mwachitsanzo. PCR iyenera kuganiziridwa kuti ipewe matenda mwa anthuwa.

Chipangizo cha InnoScreen TM COVID-19 Antigen Rapid Test Chipangizo ndi chogwiritsira ntchito mu vitro diagnostic ndipo chiyenera kugwiritsidwa ntchito pozindikira kuti SARS-CoV-2 antigen ili bwino. Kuchuluka kwa mtundu mu gulu labwino sikuyenera kuyesedwa ngati "kuchuluka kapena kuwerengeka". Mayesowa ndi ongoyesa mongoganizira chabe. Funsani sing'anga kuti mutsimikizire zotulukapo zake pogwiritsa ntchito kuyezetsa kwa PCR mu labotale ndipo chisamaliro chachipatala chotsatira chiyenera kuganiziridwa nthawi zonse.
Ma virus onse otheka komanso osatheka a SARS-CoV-2 amapezeka ndi COVID-19 antigen Rapid Test Device. Kuyesa kumatengera kuchuluka kwa ma antigen pachitsanzocho ndipo sikungafanane ndi chikhalidwe cha cell chomwe chimachitidwa pachitsanzo chomwecho.
Mofanana ndi mayesero onse okhudzana ndi matenda, chidziwitso chotsimikizika chachipatala sichiyenera kutengera zotsatira za mayeso amodzi koma ziyenera kuchitidwa ndi dokotala pambuyo pofufuza zonse zachipatala ndi ma laboratory.

Kulephera kutsatira TEST PROCEDURE ndi RESULT INTERPRETATION kungasokoneze momwe mayeso akuyendera komanso/kapena kulepheretsa zotsatira zake.
Chotsatira choyipa chikhoza kuchitika ngati mlingo wa antigen wochotsedwa mu chitsanzo uli pansi pa kukhudzidwa kwa mayesero kapena ngati chitsanzo chopanda khalidwe chasonkhanitsidwa. Kuyendera kosayenera kapena kusungidwa kwa sample lithanso kubweretsa zotsatira zoyipa zabodza.
Zotsatira zabwino sizingatsimikizire ngati munthu ali ndi matenda. Kuyezetsa kotsimikizika ndi kuyezetsa kwa labotale kwa PCR kuyenera kuganiziridwa kuti kutsimikizire kuti ali ndi kachilomboka mwa anthuwa kuti atsatire chithandizo chamankhwala.

Zotsatira zomwe zapezedwa ndi kuyesedwa uku, makamaka ngati mizere yoyesera yofooka yomwe ili yovuta kutanthauzira, iyenera kugwiritsidwa ntchito pamodzi ndi zina zachipatala zomwe dokotala angapeze.
Kugwiritsa ntchito mayeso ofulumira a antigen powunika anthu asymptomatic kapena odwala kumapeto kwa stagmatenda (kupitirira masiku 7 chiyambireni chizindikiro) akhoza kutulutsa zotsatira zabodza chifukwa cha kuchepa kwa antigen komwe kumaperekedwa m'magawo awa.amples. Chonde onani kuwunika kwachipatala kuti mumve zambiri.

NKHANI ZA NTCHITO

Kuunika Kwachipatala
Kafukufuku wachipatala adachitika kuti afanizire zotsatira zomwe zidapezeka pa InnoScreen COVID-19 Antigen Rapid Test Device mavesi RT-PCR.
Masamba odzisonkhanitsa okha kuchokera kwa omwe adatenga nawo gawo a 1486 omwe ali ndi zizindikiro kapena opanda chizindikiro adayesedwa. InnoScreen COVID-19 Antigen Rapid Test Device ili ndi chidwi chonse cha 89.47% kwa wodwala zizindikiro (m'masiku 7 chiyambireni chizindikiro) ndi 68.75% kwa wodwala wopanda zizindikiro. Kukhazikika ndi 99.53%.

Kugwiritsa Ntchito Phunziro

Kafukufuku wogwiritsa ntchito anachitidwa kwa munthu wamba. Ophunzira 224 omwe adalembetsa adapatsidwa zida ndi malangizo oti azigwiritsa ntchito kudziyesa okha popanda thandizo lina lililonse. Kukhudzika kwachibale kunali 92.31% (24/26) ndipo zenizeni zinali 100% (198/198) poyerekeza ndi RT-PCR. Zotsatira zikuwonetsa kuti mayesowa ndi osavuta kumva komanso kuchita ndi munthu wamba.

Malire ozindikira

Malire odziwika a InnoScreen COVID-19 Antigen Rapid Test Device adatsimikiziridwa kukhala 126 TCID50/mL pogwiritsa ntchito kachilombo ka SARS-CoV-2 Virus.

TCID50 (Median Tissue Culture Infectious Dose) ndi njira yogwiritsidwa ntchito ndi katswiri wa virologist kuti atsimikizire kuti kachilombo ka HIV kakuyesedwa.

Mitundu ya SARS-CoV-2

Mitundu yotsatirayi ya SARS-CoV-2 idayesedwa pa InnoScreen COVID-19 Antigen Rapid Test Device. Mitundu yonse imatha kuzindikirika pamlingo womwe watchulidwa pamwambapa.

Zosiyanasiyana za SARS-CoV-2 za Concern zayesedwa
B. 1.1.7	Alpha	United Kingdom
B. 1.351	beta	South Africa
B.1.427/B.1.429	Epsilon	United States
B. 1.617.2	Delta	India
P.1	gamma	Japan/Brazil

Kuyambiranso kwa Mtanda

Tizilombo totsatira ta commensal ndi pathogenic timene titha kukhala m'mphuno tidayesedwa pa InnoScreen TM COVID-19 Antigen Rapid Test Device kuti tigwirenso ntchito komanso kusokonezedwa.
Kuphatikizika kapena kusokoneza komwe kumachitika chifukwa cha tizilombo toyambitsa matenda sikutheka kuchitika.

Tizilombo tating'onoting'ono tayesedwa
HCoV-HKU1	Parainfluenza 1/2/3 kachilombo
HCoV-OC43	Metapneumovirus yamunthu
HCoV-NL63	rhinoviruses
HCoV-229E	Coxsackie virus A16
Chikuku kachilombo	Haemophilus influenzae
Streptococcus pneumoniae	candida albicans
Vuto la Epstein-Barr	Mycobacterium chifuwa chachikulu
Bordetella parapertussis	Norovirus
Bordetella pertussis	Mumpu virus
Fuluwenza A (H1N1)pdm09	Legionella pneumophila
Fuluwenza A (H3N2)	Mycoplasma chibayo
Fuluwenza A (H5N1)	chlamydia chibayo
Fuluwenza A (H7N9)	Streptococcus pyogene
Fuluwenza A (H7N7)	Streptococcus agalactiae
Influenza B Victoria mzere	Gulu C Streptococcus
Influenza B Yamagata mzere	Staphylococcus aureus
kachilombo kamene kayambitsa matenda ya mapapu	Ophatikizidwa amphuno wosambitsa
Matenda a Adenovirus

Kusokoneza Zinthu

Zinthu zotsatirazi, zomwe zimapezeka mwachilengedwe m'zitsanzo zopumira kapena zomwe zitha kulowetsedwa m'njira yopumira, zidayesedwa pa InnoScreen TM COVID-19 Antigen Rapid Test Device. Palibe kusokoneza komwe kunapezeka kuti kumakhudza magwiridwe antchito a mayeso.

Zinthu zoyesedwa
3 OTC opopera pamphuno	Guaiacol glyceryl ether
3 OTC zotsuka pakamwa	Nkhumba
3 OTC akutsika pakhosi	Mupirocin
4-acetamidophenol	Oxymetazoline
Acetylsalicylic acid	Phenylephrine
Albuterol	Phenylpropanolamine
Chlorpheniramine	Relenza (zanamivir)
Dexamethasone	Rimantadine
Mankhwala "Dextromethorphan".	Tamiflu (oseltamivir)
Diphenhydramine	Zamgululi
Doxylamine ndi mankhwala	Triamcinolone
Flunisolide

thandizo

Mayiko ndi madera

Australia Capital Territory Coronavirus Helpline	02 6207 7244
	https://health.act.gov.au/
New South Wales Coronavirus Helpline (Service NSW)	137 788
	https://www.health.nsw.gov.au/
Northern Territory Coronavirus National Hotline	1800 020 080
	https://health.nt.gov.au/
Thandizo la Queensland Coronavirus	134 268
	https://www.health.qld.gov.au/
South Australia Coronavirus Helpline	1800 253 787
	https://www.sahealth.sa.gov.au/
Tasmanian Public Health Hotline	1800 671 738
	https://www.health.tas.gov.au/
Victoria Coronavirus Hotline	1800 675 398
	https://www.dhhs.vic.gov.au/
Western Australia Coronavirus Hotline	1800 595 206
	https://www.healthywa.wa.gov.au/

Othandizira ukadaulo

Ngati muli ndi mafunso okhudzana ndi kugwiritsa ntchito mankhwalawa, chonde imbani thandizo la Innovation Scientific kudziyesa nokha 1300 165 061 (9am mpaka 7pm AEST/9am mpaka 8pm AEDT) kapena imelo covid19support@innovationsci.com.au.
Mavuto amachitidwe oyesera atha kufotokozedwanso ku TGA kudzera mu pulogalamu ya Users Medical Device Incident Report (imelo iris@tga.gov.au kapena imbani 1800 809 361).

MALAMULO A ZIZINDIKIRO

In vitro diagnostic
Chenjezo
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Gwiritsani ntchito tsiku
wopanga
Khodi yamagulu
Musagwiritsenso ntchito
Nambala ya Catalog
Kutentha malire
Chiwerengero cha mayesero

Chopangidwa ndi:
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NSW 2756 Australia
Website: www.innovationsci.com.au

Jambulani kachidindo ka QR kuti mupeze maphunziro apa intaneti Kuti Muthandize Makasitomala Imbani 1300 165 061 (9am - 7pm AEST/ 9am - 8pm AEDT, masiku 7 pa sabata)

Zolemba / Zothandizira

InnoScreen SCOV-23-H002 COVID-19 Antigen Rapid Test Chipangizo [pdf] Buku la Malangizo
SCOV-23-H002 COVID-19 Antigen Rapid Test Device, SCOV-23-H002, COVID-19 Antigen Rapid Test Device, Antigen Rapid Test Chipangizo, Rapid Test Chipangizo, Chida Choyesera, Chipangizo