PRAXISDIENST 491005 Nadal RSV Test Instruction Manual

PRAXISDIENST 491005 Nadal RSV Test Instruction Manual

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Ntchito Yogwiritsidwa Ntchito

The NADAL® RSV Test ndi lateral flow chromatographic immunoassay for the qualitative diagnosis of kupuma syncytial virus (RSV) mu nasopharyngeal aspirates ndi swabs. Mayesowa adapangidwa kuti agwiritsidwe ntchito ngati chithandizo pozindikira matenda obwera chifukwa cha kupuma kwa RSV ndipo adapangidwa kuti azingogwiritsidwa ntchito ndi akatswiri okha.

Chiyambi ndi Kufunika Kwachipatala

RSV ndi kachilombo koyambitsa kupuma kofala kwambiri mwa makanda ndi ana aang'ono. Amagwira pafupifupi ana onse akafika zaka ziwiri. Mwa ana ambiri, kachilomboka kamayambitsa zizindikiro zofanana ndi za chimfine. Mwa makanda obadwa msanga komanso/kapena ndi matenda osatha a m'mapapo, RSV imatha kuyambitsa matenda oopsa kapena owopsa. Asanakhazikitsidwe Synagis®, matenda a RSV amabweretsa zipatala zopitilira 125,000 pachaka. Panali chiopsezo chachikulu cha imfa pakati pa pafupifupi 2% ya makanda. Zizindikiro za RSV zingaphatikizepo kutentha thupi, mphuno ndi zizindikiro zina zazikulu monga kutsokomola, kupuma kovuta komanso kupuma mofulumira kapena kupuma.

Mfundo Zoyeserera

Mayeso a NADAL® RSV ndi lateral flow chromatographic immunoassay pakuzindikira kwamtundu wa RSV (kupumira syncytial virus) mu nasopharyngeal aspirates ndi swabs.

Kuphatikizika kwa monoclonal antibody-dye conjugates ndi ma antibodies a polyclonal solid phase amagwiritsidwa ntchito mu NADAL® RSV Test kuti azindikire mosankha RSV yokhala ndi chidziwitso chambiri komanso tsatanetsatane.

Pambuyo kusonkhanitsa ndi mankhwala mongaample, madontho ochepa ake amawonjezedwa ku sample bwino ( ⇒ ) ya kaseti yoyesera.

Monga sample imasamuka motsatira nembanemba, ma antibody-dye conjugates amamanga ku ma antigen a RSV (ngati alipo mu s.ample), kupanga ma antibody-antigen complexes. Pakakhala zotsatira zabwino, zovutazi zimamangiriza ku ma antibodies a polyclonal m'chigawo choyesera cha kaseti yoyesera ndikupanga mzere wa pinki. Kulibe RSV, palibe mzere womwe umapezeka mugawo la mayeso a kaseti yoyesera. Zomwe osakaniza akupitiriza kusamukira pamodzi nembanemba wa mayeso kaseti. Ma conjugates osamangika amamangiriza ma reagents omwe ali m'chigawo cha mzere wolamulira, kupanga mzere wa pinki-rose, womwe umasonyeza kuti chiwerengero choyenera cha chitsanzo chawonjezeredwa ndipo kupukuta kwa membrane kwachitika.

Ma reagents ndi Zida Zoperekedwa

• 20 NADAL® RSV makaseti oyesera
• 20 ma pipette otayika
• 20 zikomo
• 2 mabotolo a buffer (11 ml)
• 1 phukusi loyika

Zida Zowonjezera Zofunikira

• powerengetsera
• Pulasitiki chubu (kwa mphindi 1 ml buffer)
• 0,5 ml-mapaipi
• 1 ml-pipettes (ngati kuli kofunikira)
• Dilution medium yoyenera (monga saline wosabala, wa aspirates)
• Catheter kapena ntchofu msampha (kwa aspirates)

Kusungirako & Kukhazikika

Zida zoyesera za NADAL® RSV ziyenera kusungidwa pa 4-30 ° C ndikugwiritsidwa ntchito pofika tsiku lotha ntchito lomwe lasonyezedwa pa phukusi. Osawumitsa zida zoyesera. Osagwiritsa ntchito mayeso atatha tsiku lotha ntchito.

Machenjezo ndi Mosamala

• Kwa akatswiri a in-vitro diagnostic ntchito kokha.
• Werengani mosamala njira yoyeserera musanayesedwe.
• Osagwiritsa ntchito mayeso kupitirira tsiku lotha ntchito lomwe lasonyezedwa pa phukusi.
• Osagwiritsa ntchito mayeso ngati thumba la zojambulazo lawonongeka.
• Osagwiritsanso ntchito mayeso.
• Osawonjezera samples to the reaction area (gawo lotsatira).
• Kuti mupewe kuipitsidwa, musakhudze malo ochitirapo (zotsatira) kapena malo omiza.
• Pewani kuipitsidwa ndi tizitsanzo pogwiritsa ntchito chubu chatsopano pa chitsanzo chilichonse chomwe mwapeza.
• Osalowetsa kapena kusakaniza zigawo za zida zoyesera zosiyanasiyana.
• Tsukani bwinobwino zinthu zimene zatayikira, pogwiritsa ntchito mankhwala oyenera ophera tizilombo.
• Osadya, kumwa kapena kusuta m'malo omwe zitsanzo ndi zida zoyesera.
• Valani zovala zodzitchinjiriza monga makhoti a labotale, magolovesi otayika komanso zoteteza maso pamene zitsanzo zikuyesedwa.
• Gwirani zitsanzo zonse ngati zili ndi tizilombo toyambitsa matenda. Yang'anirani njira zodzitetezera pakuwopsa kwa tizilombo toyambitsa matenda m'njira zonse ndi malangizo anthawi zonse a katayidwe koyenera kwa zitsanzo.
• Zida zoyesera zimakhala ndi zinthu zochokera ku nyama. Chidziwitso chotsimikizika cha chiyambi ndi / kapena chikhalidwe chaukhondo cha zinyama sichimatsimikizira kuti palibe mankhwala opatsirana opatsirana. Chifukwa chake tikulimbikitsidwa kuti mankhwalawa azigwiritsidwa ntchito ngati omwe angathe kupatsirana, ndikusamalidwa motsatira njira zodzitetezera nthawi zonse (mwachitsanzo, osameza kapena kutulutsa mpweya).
• Chinyezi ndi kutentha zingasokoneze zotsatira za mayeso.
• Zida zoyesera zogwiritsidwa ntchito ziyenera kutayidwa malinga ndi malamulo amderalo.

Kusonkhanitsa ndi Kukonzekera

Ndemanga:

• Chithunzi cha RSVamples ayenera kumwedwa pafupifupi kuchokera kupuma thirakiti.
• Gwiritsani ntchito msampha wa ntchofu kapena catheter kuti mutenge nasopharyngeal aspirate sample.
• Nasopharyngeal swabs itha kugwiritsidwanso ntchito ndi mayesowa. Komabe, iwo ndi otsika pang'ono kwa nasopharyngeal aspirate samples.
• Ngati swab sinayesedwe nthawi yomweyo, iyenera kusungidwa mu chidebe choyera ndi chowuma (osaperekedwa) pa 2-8 ° C ndikuyesedwa mkati mwa maola 24 otsatira.
• Osagwiritsa ntchito njira ina iliyonse.

Nasopharyngeal aspirate

1. Pambuyo pa sampPosonkhanitsa pogwiritsa ntchito njira yoyenera, tsitsani aspirate ya nasopharyngeal ndi sing'anga yoyenera (mwachitsanzo, saline wosabala) mpaka kuchuluka kwa 3 ml.
2. Onjezerani 1 ml ya madzi osungunukaample (kapena 2 x 0.5 ml) ku chubu chapulasitiki ndi centrifuge kwa mphindi 10 pa 3,500 rpm.
3. Chotsani champhamvu ndikuyimitsanso pellet mu 0.5 ml ya buffer. Pogwiritsa ntchito pipette, sakanizani kuyimitsidwa bwino ndikubwereza mobwerezabwereza pipetting.
4. Lolani yankho la m'zigawo kuti liyime kwa mphindi 15 musanayambe kuyesa.

Mphuno ya Nasopharyngeal

1. Sungani swab ya nasopharyngeal sample, pogwiritsa ntchito swabs kapena swabs wosabala ndi nsonga za rayon kapena dacron. (Zindikirani: Osagwiritsa ntchito swabs zokhala ndi thonje kapena calcium alginate nsonga, matabwa amatabwa kapena zothiridwa ndi makala kapena zoyendera zokhala ndi agar kapena gelatin).
2. Mukangosonkhanitsa, mizani swab mu chubu chapulasitiki ndikuwonjezera 1 ml ya Buffer (kapena 2 x 0.5 ml) ndikuzunguliza swab mwamphamvu kwa masekondi 10 kuti mutsimikize kutulutsa kokwanira.
3. Lolani yankho la m'zigawo kuti liyime kwa mphindi 15.
4. Pamapeto pa nthawi yochotsa, finyani madzi kuchokera ku swab bwino ndikukankhira pa khoma la chubu.
5. Tayani swab molingana ndi malangizo anthawi zonse a kutaya koyenera kwa zida zopatsirana.

Njira Yoyesera

Bweretsani zoyeserera, zoyeserera, zotchingira ndi/kapena zowongolera kutentha kwachipinda (15-30°C) musanayesedwe.

1. Chotsani makaseti oyesera m'thumba lomata ndikugwiritsa ntchito posachedwa.
2. Kugwira pipette molunjika, perekani madontho 6 (200 µL) a yankho lotulutsidwa mu s.ampbwino ( ⇒).
3. Yambani nthawi.
4.  Werengani zotsatira zoyeserera ndendende mphindi 10 mutawonjezera yankho lochotsedwa ku sampbwino.

Kutanthauzira Zotsatira

zabwino

Mizere iwiri yamitundu ikuwonekera. Mzere umodzi wachikuda umapezeka m'chigawo cha mzere wowongolera (C) ndipo mzere wina wachikuda umapezeka mugawo la mayeso (T).

Wachisoni

Mzere umodzi wokha wachikuda umapezeka m'chigawo cha mzere wolamulira (C). Palibe mzere wachikuda womwe umapezeka mugawo la mayeso (T).

Cholakwika

Mzere wowongolera ukulephera kuwonekera. Zotsatira za mayeso aliwonse omwe sanapange mzere wowongolera pa nthawi yowerengera yoyenera ziyenera kutayidwa. Chonde review ndondomekoyi ndikubwereza mayesowo ndi kaseti yatsopano yoyesera.

Vuto likapitilira, siyani kugwiritsa ntchito zida zoyeserera nthawi yomweyo ndipo funsani wofalitsa wapafupipafupi. Kusakwanira kwa kuchuluka kwa zitsanzo, njira yolakwika yogwiritsira ntchito kapena kuyesa komwe kutha nthawi yake ndizo zifukwa zomwe zingayambitse kulephera kwa mzere wowongolera.

Control Quality

Dongosolo la mkati mwadongosolo likuphatikizidwa mumzere woyesera:

Mzere wachikuda womwe ukuwoneka mu gawo la mzere wowongolera (C) umatengedwa ngati njira yoyendetsera mkati. Imatsimikizira kuchuluka kokwanira kwa sampuli, kupukuta kokwanira kwa membrane ndi njira yoyenera.

Good Laboratory Practice (GLP) imalimbikitsa kugwiritsa ntchito zida zowongolera kuti zitsimikizire kuti zida zoyeserera zikuyenda bwino.

sitingathe

• Mayeso a NADAL® RSV adapangidwa makamaka kuti athe kuzindikira bwino kwa RSV mu nasopharyngeal aspirates ndi swabs.
• Mofanana ndi njira iliyonse yodziwira, dokotala ayenera kuyesa deta yomwe yapezeka ndi NADAL® RSV Test mogwirizana ndi njira zina zachipatala.

Zochita Zochita

lolondola

Kafukufuku adachitika pa 49 positive, nasopharyngeal aspirate sampzochepa zopezedwa kuchokera kwa ana omwe akudwala RSV mtundu wa bronchiolitis (RSV A, RSV B kapena RSV yosadziwika) ndi ena 47 nasopharyngeal aspirates opanda kachilombo.

Zotsatira zomwe zinapezedwa ndi NADAL® RSV Test zinafanizidwa ndi zotsatira za immunofluorescence zomwe zinapezedwa pogwiritsa ntchito IMAGEN RSV kit (DAKO).

Matenda a RSV-positive ndi RSV-negative sampLes adayesedwa pogwiritsa ntchito NADAL® RSV Test ndipo adatsimikiziridwa ndi immunofluorescence ndi njira ya chikhalidwe.

Kukhudzidwa kwachibale: 86% (42/49)
Zofananira: 94% (44/47)
Chigwirizano chonse: 90% (86/96)

Mmodzi sample, lomwe silinaphatikizidwe patebulo pamwambapa, linapezeka kuti silili bwino ndi njira ya immunofluorescence ndipo linapezeka kuti lili ndi vuto pogwiritsa ntchito NADAL® RSV Test. Zinatsimikiziridwa ngati zabwino sampndi njira ya PCR.

Kuyambiranso

Nasopharyngeal aspirates positive for parainfluenza virus (2 samples), rhinovirus (7 samples) kapena adenovirus (2 samples) adayesedwa, pogwiritsa ntchito mayeso a NADAL® RSV ndipo adawonetsa mobwerezabwereza zotsatira zoyipa, pomwe kupezeka kwa ma virus omwe tawatchulawa mu s.ampLes adatsimikiziridwa ndi chikhalidwe cha maselo kapena njira za immunofluorescence.

Zothandizira

1. Chanock, RM, ndi L. Findberg. 1957. Kuchira kuchokera kwa makanda omwe ali ndi matenda opuma a kachilombo kokhudzana ndi chimpanzi coryza agent (CCA). II. Epidemiologic mbali za matenda mwa makanda ndi ana aang'ono. Ndi. J. Hyg.66 : 291-300.
2. Chanock, RM, HW Kim, AJ Vargosko, A. Deleva, KM Johnson, C.Cumming, ndi RH Parrott. 1961. Respiratory syncytial virus. I. Kuchira kwa kachilomboka ndi zowonera zina mu 1960 kuphulika kwa bronchiolitis, chibayo, ndi matenda ang'onoang'ono a kupuma kwa ana. J. Am. Med. Assoc. 176 : 647-653.
3. Hall, CB, RG Douglas, ndi JM Geiman. 1976. Matenda opumira a syncytial virus mu makanda: kuchuluka ndi nthawi yokhetsedwa. J. Pediatr. 89 : 1443- 1447.
4. Hall, C,B,JT McBride, EE Walsh, DM Bell, CL Gala, S.Hildreth, LG Teneyck, ndi WW.J. Hall. 1983. Aerosolized ribavirin mankhwala a makanda ndi kupuma syncytial HIV matenda. N.Chingerezi. J. Med. 308 : 1443-1447.
5. Taber, LHV, Knight, BE Gilbert, HW McClung, SZ Wilson, HJ Norton, JM Thurson, WH Gordon, RL Atmar ndi WR Schlaudt. 1983. Ribavirin aerosol mankhwala a bronchiolitis okhudzana ndi kupuma kwa syncytial virus matenda mwa makanda. Matenda a ana 72: 613-618.
6. Ahluwalia, GJ Embree, P. McNicol, B.Law, ndi GW Hammond. 1987. Kuyerekeza kwa nasopharyngeal aspirate ndi nasopharyngeal swab za kupuma kwa syncytial kachilombo ka HIV ndi chikhalidwe cha cell, indirect immunofluorescence assay, ndi enzyme-linked immunoabsorbent assay. J.Clin. Microbiol. 257 : 763-767.

 

 

Rev. 4, 2017-05-31 OM/UJa

 

 

Zolemba / Zothandizira

	PRAXISDIENST 491005 Nadal RSV Mayeso [pdf] Buku la Malangizo 491005 Nadal RSV Test, 491005, Nadal RSV Test, RSV Test, Test
	PRAXISDIENST 491005 NADAL RSV Mayeso [pdf] Buku la Malangizo 491005 NADAL RSV Test, 491005, NADAL RSV Test, RSV Test, Test
	PRAXISDIENST 491005 NADAL RSV Mayeso [pdf] Buku la Malangizo 491005 NADAL RSV Test, 491005, NADAL RSV Test, RSV Test, Test

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• nal von minden GmbH