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 is a lateral flow chromatographic immunoassay for the qualitative detection of respiratory syncytial virus (RSV) in nasopharyngeal aspirates and swabs. This test is intended for use as an aid in the diagnosis of respiratory tract infections caused by RSV and is designed for professional use only.

Chiyambi ndi Kufunika Kwachipatala

RSV is the most common respiratory virus in infants and young children. It infects virtually all children by the age of two. In most children, the virus causes symptoms resembling those of the common cold. In infants born prematurely and/or with chronic lung disease, RSV can cause a severe or even life threatening disease. Prior to the introduction of Synagis®, RSV disease resulted annually in over 125,000 hospitalisations. There was a high mortality risk amongst approximately 2% of infants. Symptoms of RSV can include fever, runny nose and other more serious symptoms like coughing, difficult and rapid breathing or wheezing.

Mfundo Zoyeserera

The NADAL® RSV Test is a lateral flow chromatographic immunoassay for the qualitative detection of RSV (respiratory syncytial virus) in nasopharyngeal aspirates and 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 well (⇒) of the test cassette.

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 test cassettes
  • 20 disposable pipettes
  • 20 zikomo
  • 2 bottles of Buffer (11 ml)
  • 1 phukusi loyika

Zida Zowonjezera Zofunikira

  • powerengetsera
  • Plastic tube (for min. 1 ml buffer)
  • 0,5 ml-pipettes
  • 1 ml-pipettes (if necessary)
  • Appropriate dilution medium (e.g. sterile saline, for aspirates)
  • Catheter or mucus trap (for 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).
  • In order to avoid contamination, do not touch the reaction area (result area) or the immersion area.
  • Avoid cross-contamination of specimens by using a new extraction tube for each specimen obtained.
  • Osalowetsa kapena kusakaniza zigawo za zida zoyesera zosiyanasiyana.
  • Clean up spillage thoroughly, using an appropriate disinfectant.
  • 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.
  • Handle all specimens as if they contain infectious agents. Observe established precautions for microbiological risks throughout all procedures and standard guidelines for the appropriate disposal of specimens.
  • 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:

  • RSV samples should be taken almost exclusively from the respiratory tract.
  • Use a mucus trap or a catheter to collect nasopharyngeal aspirate sample.
  • Nasopharyngeal swabs may also be used with this test. However, they are somewhat inferior to nasopharyngeal aspirate samples.
  • If a swab is not tested immediately, it should be stored in a clean and dry container (not supplied) at 2-8°C and tested within the next 24 hours.
  • Do not use any holding medium.

Nasopharyngeal aspirate

  1. Pambuyo pa sample collection using a suitable procedure, dilute the nasopharyngeal aspirate with appropriate medium (e.g. sterile saline) up to a maximum volume of 3 ml.
  2. Add 1 ml of the diluted sample (kapena 2 x 0.5 ml) ku chubu chapulasitiki ndi centrifuge kwa mphindi 10 pa 3,500 rpm.
  3. Discard the supernatant and resuspend the pellet in 0.5 ml of buffer. Using the pipette, mix the suspension well by repeated up and down pipetting.
  4. Allow the extraction solution to stand for 15 minutes before performing the test.

Mphuno ya Nasopharyngeal

  1. Collect a nasopharyngeal swab sample, using provided swabs or sterile swabs with rayon or dacron tips. (Note: Do not use swabs with cotton or calcium alginate tips, wooden shafts or impregnated with charcoal or transport media containing agar or gelatin).
  2. Immediately after collection, immerse the swab into a plastic tube with added 1 ml of Buffer (or 2 x 0.5 ml) and swirl the swab vigorously for 10 seconds to ensure adequate extraction.
  3. Allow the extraction solution to stand for 15 minutes.
  4. At the end of the extraction time, squeeze the liquid from the swab thoroughly by pressing it against the tube wall.
  5. Discard the swab in accordance with standard guidelines for the appropriate disposal of infectious materials.

Njira Yoyesera

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) prior to testing.

PRAXISDIENST 491005 Nadal RSV Test - Test Procedure

  1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
  2. Holding the pipette vertically, dispense 6 drops (200 µL) of the extracted solution into the sample well (⇒).
  3. Yambani nthawi.
  4.  Read the test result exactly 10 minutes after adding the extracted solution to the sampbwino.

Kutanthauzira Zotsatira

zabwino

PRAXISDIENST 491005 Nadal RSV Test - Positive

Two coloured lines appear. One coloured line appears in the control line region (C) and the other coloured line appears in the test line region (T).

Wachisoni

PRAXISDIENST 491005 Nadal RSV Test - Negative

Only one coloured line appears in the control line region (C). No coloured line appears in the test line region (T).

Cholakwika

PRAXISDIENST 491005 Nadal RSV Test - Invalid

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.

If the problem persists, discontinue using the test kit immediately and contact your local distributor. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for the control line failure.

Control Quality

An internal procedural control is included in the test strip:

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

  • The NADAL® RSV Test is specifically designed for the qualitative detection of RSV in nasopharyngeal aspirates and swabs.
  • As with any diagnostic procedure, the physician should evaluate data obtained with the NADAL® RSV Test in conjunction with other clinical methods.

Zochita Zochita

lolondola

A study was performed on 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.

PRAXISDIENST 491005 Nadal RSV Test - Accuracy

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, R.M., and L. Findberg. 1957. Recovery from infants with respiratory illness of a virus related to chimpanzee coryza agent (CCA). II. Epidemiologic aspects of infection in infants and young children. Am. J. Hyg.66 : 291-300.
  2. Chanock, R.M., H.W. Kim, A.J. Vargosko, A. Deleva, K.M. Johnson, C.Cumming, and R.H. Parrott. 1961. Respiratory syncytial virus. I. Virus recovery and other observations during 1960 outbreak of bronchiolitis, pneumonia, and minor respiratory diseases in children. J. Am. Med. Assoc. 176 : 647-653.
  3. Hall, C.B, R.G. Douglas, and J.M. Geiman. 1976. Respiratory syncytial virus infections in infants: quantitation and duration of shedding. J. Pediatr. 89 : 1443- 1447.
  4. Hall, C,B,J.T. McBride, E.E. Walsh, D.M. Bell, C.L. Gala, S.Hildreth, L.G. Teneyck, and WW.J. Hall. 1983. Aerosolized ribavirin treatment of infants with respiratory syncytial virus infection. N.Engl. J. Med. 308 : 1443-1447.
  5. Taber, L.H.V, Knight, B.E. Gilbert, H.W. McClung, S.Z. Wilson, H.J. Norton, J.M. Thurson, W.H. Gordon, R.L. Atmar and W.R. Schlaudt. 1983. Ribavirin aerosol treatment of bronchiolitis associated with respiratory syncytial virus infection in infants. Pediatrics 72 : 613-618.
  6. Ahluwalia, G.J. Embree, P. McNicol, B.Law, and G.W. Hammond. 1987. Comparison of nasopharyngeal aspirate and nasopharyngeal swab specimens for respiratory syncytial virus diagnosis by cell culture, indirect immunofluorescence assay, and enzyme-linked immunoabsorbent assay. J.Clin. Microbiol. 257 : 763-767.

 

 

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

 

 

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PRAXISDIENST 491005 Nadal RSV Mayeso [pdf] Buku la Malangizo
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