ZL26/R Tests

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1 Key Coe TSMX7713B Europe US CA ROW Wellogen TM Bteril Antigen Kit ZL26/R Tests 1 Intene Use EN The Wellogen TM Bteril Antigen Kit provies series of rpi ltex tests for use in the qulittive etetion of ntigen from Streptoous group B, Hemophilus influenze type, Streptoous pneumonie (pneumoous), Neisseri meningitiis (meningoous) groups A, B, C, Y or W135 n Esherihi oli K1 present in ererospinl flui (CSF) s onsequene of infetion. The kit n lso e use to test other oy fluis or loo ulture superntnts for most of these ntigens n plte ultures for N. meningitiis group B or Esherihi oli K1. (See Tle 1 for initions supporte y linil t). NOTE: Tests performe iretly on linil speimens re intene for sreening purposes n shoul ugment, not reple, ulture proeures. Results must e use in onjuntion with other t; e.g. symptoms, results of other tests, linil impressions et. 2 Summry Meningitis hs wie vriety of potentil uses, either infetious or noninfetious. If teril meningitis is not trete promptly n effetively, the isese is likely to e ftl. Erly ientifition of the infeting gent n e of onsierle vlue in proviing the ptient with pproprite n equte hemotherpy. Mny teril speies hve een implite in meningitis. Streptoous group B n E. oli K1 re two of the most ommon uses of neontl sepsis whilst in oler ge groups the ommonest isoltes re H. influenze type, S. pneumonie n N. meningitiis groups A, B, C, Y n W135. These orgnisms rry speifi polyshrie surfe ntigens, quntity of whih iffuses into ulture mei or oy fluis suh s CSF or serum, n is exrete in the urine. The ntigens n e etete y sensitive immunologil methos suh s ounterimmuno-eletrophoresis n ltex gglutintion 2,5,6,10. 3 Priniple of the Test The Wellogen TM regents onsist of polystyrene ltex prtiles whih hve een ote with ntioies to the teril ntigens. These ltex prtiles gglutinte in the presene of suffiient homologous ntigen. The Streptoous n H. influenze regents re group B n type speifi respetively, the S. pneumonie regent is sensitise with ntioies purifie from n omnivlent serum n the N. meningitiis polyvlent regent rets with groups A, C, Y n W135 ntigens. Meningoous group B ntigen is more iffiult to etet 6 s well s eing struturlly n immunologilly relte to E. oli K1 ntigen 7 ; oth of these ret with the N. meningitiis group B regent. 4 SYMBOL DEFINITIONS Ctlogue Numer In Vitro Dignosti Meil Devie Contins suffiient for <n> tests Consult Instrutions for Use Temperture Limittion Bth Coe Use By Mnufturer A wter 5 Kit Contents, Preprtion for use n Storge The Wellogen TM Bteril Antigen Kit inlues suffiient regents to perform 30 tests. See lso Preutions, setion 6. All omponents shoul e store t 2 to 8 C uner whih onition they will retin their tivity until the expiry te of the kit. Before use, ring ll regents to room temperture (18-30 C) n mix. Return the unuse regents to the refrigertor fter use. Instrutions for Use isposle Retion Crs (2 pks) isposle Mixing Stiks (5 unles) isposle Droppers (1 ontiner) Blk ruer tet (1) 6 Preutions The regents re for in vitro ignosti use only. For professionl use only. Test Ltexes Strep B (pink p) H. influenze (ple lue p) S. pneumonie (yellow p) N. meningitiis ACY W135 (grey p) N. meningitiis B/E. oli K1 (rown p) Five ropper ottles, one speifi for eh of the groups ove, ontining 0.5% suspensions of polystyrene ltex prtiles in uffer ontining 0.05% Broniox n/or 0.1% soium zie s preservtive. The ltex prtiles re ote with the pproprite rit ntioy, s lelle, exept for the N. meningitiis group B/E. oli K1 regent, whih is ote with murine monolonl ntioy. Control Ltexes 5 ropper ottles (rk lue p) ontining 0.5% suspensions of polystyrene ltex prtiles in uffer ontining 0.05% Broniox n/or 0.1% soium zie s preservtive. The ltex prtiles re ote with n pproprite preprtion of rit gloulin or in the se of the N. meningitiis group B/E. oli K1 ltex, murine monolonl ntioy rise ginst Boretell ronhisepti. The ltex suspensions re provie rey for use n shoul e store t 2 to 8 C in n upright position, until the expiry te of the kit. After prolonge storge some ggregtion or rying of the ltex my hve ourre roun the top of the ottle. Uner these irumstnes the ottle of ltex shoul e shken vigorously for few seons until resuspension is omplete. DO NOT FREEZE. Polyvlent Positive Control Two ottles (lue p) ontining freeze-rie teril extrts ontining ntigens from representtive strins of eh teril speies for whih ltex is provie. Contins 0.01% ronopol efore reonstitution n 0.004% when reonstitute. Reonstitute using 3.6 ml of sterile istille wter. After the ition of wter llow the ottle to stn for few minutes n then swirl to mix. Store reonstitute ntigen t 2 to 8 C for up to 6 months. Negtive Control One ropper ottle (white p) ontining Glyine sline uffer, ph 8.2, with 0.05% Broniox s preservtive. Plese refer to the Sfety Dt Sheet (SDS) n prout lelling for informtion on potentilly hzrous omponents.

2 Helth n Sfety Informtion 6.1 The Test n Control Ltexes for Streptoous group B, H. influenze type, S. pneumonie n N. meningitiis ACY W135 ontin 0.1% soium zie. Azies n ret with opper n le use in some pluming systems to form explosive slts. The quntities use in this kit re smll; nevertheless when isposing of zie-ontining mterils they shoul e flushe wy with lrge volumes of wter. 6.2 In orne with the priniples of Goo Lortory Prtie it is strongly reommene tht oy fluis shoul e trete s potentilly infetious n hnle with ll neessry preutions. 6.3 When hnling riometri loo ulture meium, the si rules of rition sfety shoul e followe. These inlue: ) Riotive mteril shoul e store in esignte re in n pprove ontiner. ) Hnling of riotivity shoul tke ple in esignte re. ) No mouth pipetting of riotive mteril shoul e rrie out. ) No eting, rinking or smoking shoul tke ple in the esignte re. e) Hns shoul e wshe thoroughly fter using riotive mteril. f) The lol Rition Sfety Offier shoul e onsulte onerning isposl requirements. 6.4 Non-isposle pprtus shoul e sterilise y ny pproprite proeure fter use, lthough the preferre metho is to utolve for 15 minutes t 121 C. Disposles shoul e utolve or ininerte. Spillge of potentilly infetious mterils shoul e remove immeitely with sorent pper tissue n the ontminte res swe with stnr teril isinfetnt or 70% lohol. Do NOT use soium hypohlorite. Mterils use to len spills, inluing gloves, shoul e ispose of s iohzrous wste. 6.5 Do not pipette y mouth. Wer isposle gloves n eye protetion while hnling speimens n performing the ssy. Wsh hns thoroughly when finishe. 6.6 When use in orne with the priniples of Goo Lortory Prtie, goo stnrs of ouptionl hygiene n the instrutions stte in these Instrutions for Use, the regents supplie re not onsiere to present hzr to helth. Anlytil Preutions 6.7 Do not use the regents eyon the stte expiry te. 6.8 Ltex regents shoul e rought to room temperture (18 to 30 C) efore use. Ltex regents whih show signs of ggregtion or lumpiness efore use my hve een frozen n must not e use. 6.9 It is importnt when using ropper ottles tht they re hel vertilly n tht the rop forms t the tip of the nozzle. If the nozzle eomes wet n inorret volume will form roun the en n not t the tip; if this ours ry the nozzle efore progressing The regents provie with eh kit re mthe in performne n shoul not e use in onjuntion with regents from kit hving ifferent lot numer Do not touh the retion res on the rs Mehnil rottors my e use in this ssy. The following hrteristis hve een foun to e stisftory: i) Oritl rottors (lso known s imensionl rottors) operting t 25 rpm with pproximte rotting ngle of 9 to 10.5 egrees or operting t 18 rpm with rotting ngle of 16 to 17.5 egrees Avoi miroil ontmintion of regents s this my le to erroneous results. 7 Speimen Colletion n Storge 7.1 Boy flui smples (e.g. CSF, serum, urine) shoul e teste s soon fter olletion s possile. If the flui nnot e teste immeitely it my e store overnight t 2 to 8 C, or for longer perios frozen t 15 to 25 C. If teriologil nlyses re require on the smple, these shoul e set up prior to performing the ltex test, to voi ontminting the smple. 7.2 Bloo ultures my e smple n teste fter 18 to 24 hours inution t 37 C n/or s soon s teril growth is oserve. 7.3 Plte ultures (N. meningitiis B/E. oli K1 only). Isolte olonies growing on enrihe gr meium (e.g. loo, hoolte gr) my e teste fter overnight inution t 37 C. A Grm stin shoul e performe to ssist with the interprettion of the ltex test result. 8 Test Proeure Require Mterils Provie See Kit Contents, setion 5. Mterils Require ut not Provie Boiling wter th Lortory entrifuge or memrne filters (0.45 µm) Rottor (optionl refer to Preutions, setion 6) Preprtion of Clinil Speimens 8.1 Boy flui smples must e hete efore testing y the Wellogen TM proeure to minimise non-speifi retions 4,6. The following proeures re reommene: ) For CSF n urine, het the smple for 5 minutes in oiling wter th. Cool the smple to room temperture (18 to 30 C) n lrify y entrifugtion or memrne filtrtion (0.45 µm) prior to testing. For mximum sensitivity urine smples my e onentrte up to 25-fol in Minion B-15 onentrtor. Clrify s ove efore testing. ) For serum, 3 volumes 0.1 M isoium ethyleneiminetetrette (EDTA) ph 7.4 per 1 volume serum, het the smple for 5 minutes in oiling wter th, ool to room temperture (18 to 30 C) n lrify s ove. A suitle EDTA solution (10 ml) is ville (Coe No. ZL29/R ). 8.2 Bloo ultures. Centrifuge 1 to 2 ml smple to pellet the re loo ells, for exmple t 1000 g for 5 to 10 minutes. Perform the ltex test on the superntnt. If non-speifi retion ours with loo ulture superntnt (see Interprettion of Results, setion 10), het the smple in oiling wter th for 5 minutes, ool to room temperture (18 to 30 C), lrify y entrifugtion n repet the test. 8.3 Plte ultures (N. meningitiis B/E. oli K1 only). Test iretly from the ulture plte. Proeure It is reommene tht the setion on Preutions, setion 6, is re refully efore performing the test. Boy flui smples n Bloo ulture superntnts: NOTE: If there is only limite volume of test smple ville, it shoul e use with the Test Ltexes first n if positive result is otine the smple shoul e teste with the pproprite Control Ltex. If suffiient smple is ville, it shoul e teste ginst oth the Test n Control Ltexes simultneously. Step 1 Proess the smple s esrie uner Preprtion of Clinil Speimens. Step 2 Shke the ltex regents. Step 3 Ple 1 rop of eh Test Ltex or Control Ltex 1 rop into seprte irle on Retion Cr. Ensure tht the ropper ottles re hel vertilly to ispense n urte rop. (See Preutions, setion 6). Step 4 Using Disposle Dropper, ispense 1 rop 1 rop (pproximtely 40 µl) of Test Smple next to eh rop of ltex. Step 5 Mix the ontents of eh irle with Mixing Stik n spre to over the omplete re of the irle. Use seprte stik for eh irle n isr it for sfe isposl fter use. Step 6 Rok the r slowly n oserve for gglutintion 3 mins for 3 minutes, holing the r t norml reing istne (25 to 35 m) from the eyes. Do not use mgnifying lens. Mehnil rottion (3 minutes) my e use (See Preutions, setion 6). The ptterns otine re ler ut n n e reognise uner ll norml lighting onitions. Step 7 Disr the use Retion Cr for sfe isposl.

3 Plte Cultures: (Wellogen TM N. meningitiis B/E. oli K1 only): Step 1 Shke the ltex regents. Step 2 For eh ulture to e teste ple 1 rop of 1 rop Test Ltex in one irle on Retion Cr n 1 rop of Control Ltex in seprte irle. NOTE: it is essentil to use the Control Ltex for suspete E. oli ultures. Step 3 Tke Mixing Stik n pik up some of the ulture Smple y touhing it with the flt en of the stik. As guie, of n mount of growth roughly equivlent to 1 lrge growth olony shoul e pike. Step 4 Emulsify the smple of ulture in the rop of Test Ltex y ruing with the flt en of the stik. Ru thoroughly, ut not so vigorously s to mge the surfe of the r. Spre the ltex to over s muh of the irle s possile. Disr the Mixing Stik for sfe isposl. Step 5 Using seprte stik, emulsify similr smple of ulture in the Control Ltex. Step 6 Rok the r slowly n oserve for gglutintion 20 ses for 20 seons holing the r t norml reing istne (25 to 35 m) from the eyes. Do not use mgnifying lens. The ptterns otine re ler ut n n e esily reognise uner ll norml lighting onitions. Step 7 Disr the use Retion Cr for sfe isposl. 9 Qulity Control The following proeures shoul e rrie out initilly with eh shipment of test kits n with eh run of test smples. In prtie, run my e efine s testing perio of up to 24 hours. Any eprture from the expete results inites there my e prolem with the regents, whih must e resolve efore further use with linil smples. Visul Inspetion The ltex suspensions shoul lwys e inspete for ggregtion s they re roppe onto the test r n if there is eviene of lumping efore ition of the test smple, the suspension must not e use. After prolonge storge some ggregtion or rying my hve ourre roun the top of the ottle. If this is oserve, the ottle shoul e shken vigorously for few seons until resuspension is omplete. Positive Control Proeure The retivity of the test n e onfirme y ing Polyvlent Positive Control to retion irle in whih the test smple hs not gglutinte the Test Ltex fter 3 minutes rottion. Step 1 Use Disposle Dropper to 1 rop of Positive 1 rop Control to the irle ontining Test Ltex n speimen. Step 2 Mix using Mixing Stik n isr it for sfe isposl. Step 3 Rok the r mnully or y rottor for further 3 mins 3 minutes. After this time, efinite gglutintion shoul e visile in the Test Ltex. Step 4 Disr the use Retion Cr for sfe isposl. Negtive Control Proeure If t lest one test smple within run gives negtive result with Test n Control Ltexes (or Test Ltex only where no Control Ltex hs een use), this onstitutes vli negtive ontrol for the regents n no further testing is neessry. If test smple gives gglutintion with the Test Ltex n no gglutintion with the Control Ltex then the Test Ltex shoul e teste either with the Negtive Control or uninoulte loo ulture meium, s pproprite (see elow). Step 1 Ple one rop of Test Ltex in one irle on 1 rop Retion Cr. Step 2 Dispense one rop of Negtive Control or 1 rop uninoulte loo ulture meium next to the Test Ltex. Step 3 Mix using Mixing Stik n isr it for sfe isposl. Step 4 Rok the r mnully or y rottor for further 3 mins 3 minutes. After this time, there shoul e no signifint gglutintion in the Test Ltex. Step 5 Disr the use Retion Cr for sfe isposl. For tests with oy flui smples, the Negtive Control provie with the kit shoul e use. For tests with loo ultures smple of uninoulte loo ulture meium from the sme soure s the speimen shoul e use s negtive ontrol. Note: testing uninoulte mei is importnt s flse-positives n our with some formultions of loo ulture mei. Notes: ) Previously ssye positive n negtive smples, liquote n store t 15 to 25 C or elow, my e use s positive n negtive ontrols respetively, if esire. The Positive Control n lso e use in ple of the test smple. ) For olony ientifition tests (Wellogen TM N. meningitiis B/E. oli K1 only), the performne of the Test n Control Ltex regents my e onfirme using fresh, overnight ultures of referene strins of teri, following the metho esrie in Test Proeure. Suitle referene strins re: ATCC N. meningitiis group B (positive retivity) ATCC E. oli type K1 (positive retivity) ATCC N. meningitiis group A (negtive retivity) ATCC n ATCC shoul give gglutintion with the Test Ltex n no signifint gglutintion in the Control Ltex, ATCC shoul give no signifint gglutintion with either the Test or Control Ltex. 10 Results Reing of Results A positive retion is inite y the evelopment of n gglutinte pttern within 3 minutes (20 seons for olony testing) of mixing the ltex with the test smple, showing lerly visile lumping of the ltex prtiles (Figure 1). The spee of pperne n qulity of gglutintion epen on the strength of the ntigen, vrying from lrge lumps whih pper within few seons of mixing, to smll lumps whih evelop rther slowly. In ulture ientifition, most positive retions will e lmost instntneous. In negtive retion the ltex oes not gglutinte n the milky pperne remins sustntilly unhnge throughout the test (Figure 2). Note, however, tht fint tres of grnulrity my e etete in negtive ptterns, epening on the visul uity of the opertor. In ulture ientifition, some strins my use stringy ggregtion of the ltex with milky kgroun; this shoul e interprete s negtive retion. NOTE: The ltex prtiles use in the Wellogen TM N. meningitiis B/E. oli K1 Test n Control Ltex suspensions re not the sme s those use for the other regents, n give finer gglutintion. Figure 1 Figure 2 Interprettion of Results Positive Result Cler gglutintion of single Test Ltex ompnie y negtive retions with ll other Test Ltex regents n the Control Ltex inites the presene n ientity of teril ntigen in the test smple. As generl rule positive result with Wellogen TM N. meningitiis B/E. oli K1 ginst neontl speimen suggests E. oli K1 infetion; with oler ptients, meningoous group B is more likely. Negtive Result Negtive retions with ll the Test Ltex regents inites the sene of etetle level of the teril ntigens in the test flui it oes not eliminte the possiility of n infetion use y these orgnisms, n if symptoms persist it my e esirle to perform the test on susequent or lterntive speimens, or fter onentrtion of the urine speimen. With ulture, lk of gglutintion in Wellogen TM N. meningitiis B/E. oli K1 regents inites tht it is unlikely to e N. meningitiis group B or E. oli K1.

4 Non-interpretle Result Agglutintion of more thn one Test Ltex regent or orresponing Test n Control Ltexes inites non-speifi retion. In most ses, non-speifi retions with oy fluis my e eliminte y heting n lrifying the smple 4 (see Preprtion of Clinil Speimens, setion 8). If non-speifi retion ours with loo ulture superntnt, het the smple in oiling wter th for 5 minutes, ool to room temperture (18 to 30 C), lrify y entrifugtion n repet the test. 11 Performne Limittions 11.1 For infnt oy fluis (Group B strep only) Flse negtive test results my our with speimens ontining levels of ntigen elow the limits of etetion of this evie. Negtive results shoul e followe up with seletive roth ulture. A positive result inites the presene of Group B streptool ntigen; the result oes not neessrily inite the presene of vile orgnisms For infnt oy fluis (Group B strep only) Use of this evie shoul not sustitute for miroiologil ulture. Performne of this evie for preiting Group B streptool isese from tests of infnt urine hs not een estlishe Group B streptoous infetions our primrily in neontes. Positive results otine with oy flui smples from ptients oler thn six months shoul e interprete with ution. Positive results otine with loo ulture superntnts from ptients of ny ge my e signifint A positive result in the test epens on the presene of etetle level of ntigen in the oy flui or loo ulture meium Limite linil t re ville for the etetion of ntigen in urine or serum using Wellogen TM N. meningitiis B/E. oli K1 (Tle 6). No linil t is ville for the etetion of ntigen in urine using Wellogen TM N. meningitiis ACY W135 (Tle 5). However, ntigen hs een reporte in urine ACY W135 smples A few exmples hve een reporte of unrelte teri whih possess ommon ntigens n, s with ny immunologil test system, the possiility of ross retions ourring in the ltex test n not e rule out 1,3,8,9. 12 Expete results Smples ontining etetle level of group B streptool ntigen, H. influenze type ntigen, S. pneumonie psulr ntigen, N. meningitiis A, C, Y, W135 ntigens, or N. meningitiis B / E. oli K1 ntigen will give n gglutintion retion with the pproprite Test Ltex. 13 Performne Chrteristis 13.1 Boy Fluis n Bloo Cultures Clinil stuies were rrie out in 15 entres using oy flui smples (fresh n store frozen) n loo ulture superntnts. Both tritionl n riometri ulturl tehniques were use in the loo ulture stuies. Store oy flui smples were not het trete s esrie uner Preprtion of Clinil Speimens, setion 8. Extensive lortory testing hs shown no signifint loss of ntigen fter heting y this proeure. The sensitivity of eh ltex in the kit ws estlishe from tests on smples ulture positive for the homologous orgnism or for whih there ws other eviene of infetion (linil ignosis plus other ntigen test positive). Tles 2 to 6 show the numers of eh type of speimen teste with the iniviul ltexes together with the numer of positive results otine. The sensitivity of eh ltex in eteting teril ntigen in CSF ws 67% (12/18) for Wellogen TM Strep B, 97% (87/90) for Wellogen TM H. influenze, 88% (45/51) for Wellogen TM S. pneumonie, 71% (29/41) for Wellogen TM N. meningitiis ACY W135 n 65% (11/17) for Wellogen TM N. meningitiis B/E. oli K1. The speifiity of eh of the Wellogen TM regents ws evlute using oy flui (fresh n frozen) n loo ulture smples from ptients with teril or septi meningitis n other unrelte onitions. The orgnisms isolte from the infete smples were H. influenze, S. pneumonie, N. meningitiis inluing groups A, B, C, Y, E. oli, Stphyloous ureus, Enteroter erogenes, Klesiell pneumonie, Myoterium tuerulosis, Proteus mirilis, Stphyloous epiermiis, lph-hemolyti streptoous, ethemolyti streptoous group A, Klesiell oxyto, Pseuomons, Streptoous snguis, Toxoplsm gonii n oliform terium. The speifiity of ll five Wellogen TM ltexes in tests on CSF ws greter thn 98%. Detils of the numer of smples teste n the speifiity of eh Wellogen TM with eh type of speimen re given in tles 2 to Plte Cultures (N. meningitiis B/E. oli K1). N. meningitiis n E. oli ultures grown on n enrihe gr meium were teste in hospitl lortories n In-house. All N. meningitiis group B n E. oli K1 ultures were orretly ientifie. There were no ross-retions with other groups of N. meningitiis or other E. oli K ntigens (Tle 7). A high proportion of the E. oli ultures with other K ntigens whih were teste gve non-speifi retions (Tle 7). Tle 1 Speimens whih hve een evlute with iniviul Wellogen TM ltex regents Speimen Wellogen TM Strep. B H. influenze S. pneumonie N. meningitiis N. meningitiis B/ ACY W135 E. oli K1 CSF Serum * Urine * +* Bloo Culture Bteril olonies + Key + Dt ville to support this pplition. +* Limite t ville. No t ville. Tle 2 Results of linil stuies on Wellogen TM Strep B Smple No. teste No. positive No. teste No. positive CSF Serum Urine Bloo Culture e et-hemolyti streptoous group B isolte/inite (linil ignosis/ other ntigen test). Bteri other thn Strep. B/no growth. E. oli isolte. P. mirilis isolte. e Stph. epiermiis; et-hemolyti strep. group A; E. oli + Enteroous; Stph. epiermiis + Enteroous isolte. Tle 3 Results of linil stuies on Wellogen TM H. influenze Smple No. teste No. positive No. teste No. positive CSF Serum Urine Bloo Culture One itionl CSF smple gve non-speifi retion. One smple septi; E. oli isolte from other smple. Two itionl loo ulture superntnts gve non-speifi retions. One smple septi. Other smples grew: Stph. ureus; E. oli + Stph. epiermiis; K. oxyto; lph-hemolyti streptoous.

5 Tle 4 Results of linil stuies on Wellogen TM S. pneumonie Smple No. teste No. positive No. teste No. positive CSF Serum Urine Bloo Culture One itionl CSF gve non-speifi retion. Enteroter erogenes; oliform terium. Three itionl urine smples gve non-speifi retions. Pseuomons; Strep. snguis; Stph. epiermiis + Enteroous; Strep. virins isolte from 4 smples. Tle 5 Results of linil stuies on Wellogen TM N. meningitiis ACY W135 Smple No. teste No. positive No. teste No. positive CSF Serum Urine Bloo Culture Inlues 8 group A, 25 group C n 1 group Y (the reminer were not groupe). K. erogenes; E. oli. Five itionl urine smples gve non-speifi retions. Strep. snguis; Stph. epiermiis + Enteroous. Tle 6 Results of linil stuies on Wellogen TM N. meningitiis B/E. oli K1 Smple No. teste No. positive No. teste No. positive CSF N. meningitiis B E. oli K Serum: N. meningitiis B Urine: N. meningitiis B Bloo Culture: N. meningitiis B Smples store frozen. All other smples teste fresh. Aeroi n neroi ultures (et-hemolyti strep A) for sme ptient; ogulse negtive stphyloous. Tle 7 Ientifition of ultures using Wellogen TM N. meningitiis B/E. oli K1 Culture + N. meningitiis group A 0 16 N. meningitiis group B 10 0 N. meningitiis group C 0 18 N. meningitiis group 29E 0 8 N. meningitiis group W N. meningitiis group X 0 4 N. meningitiis group Y 0 5 N. meningitiis group Z 0 3 E. oli K1 7 0 E. oli other ntigens 0 13 Cultures ientifie y slie gglutintion. An itionl 10 ultures gve non-speifi retions. 14 Biliogrphy 1 Argmn, M., Liu, T.Y., et l (1974). Polyriitol-phosphte: n ntigen of four grm-positive teri ross-retive with the psulr polyshrie of Hemophilus influenze type. J. Immunol., 112, Bker, C.J. n Renh, M.A. (1983). Commeril ltex gglutintion for etetion of group B streptool ntigen in oy fluis. J. Peitr., 102, Bøvre, K., Bryn, K., et l (1983). Surfe polyshrie of Morxell non-liquefiens ientil to Neisseri meningitiis group B psulr polyshrie. A hemil n immunologil investigtion. NIPH Annls, 6, Doskeln, S.O. n Berl, B.P. (1980). Bteril ntigen etetion in oy fluis: methos for rpi ntigen onentrtion n reution of nonspeifi retions. J. Clin. Miroiol., 11, Feigin, R.D., Wong, M., et l (1976). Counterurrent immunoeletrophoresis of urine s well s of CSF n loo for ignosis of teril meningitis. J. Peitr., 89, Klor, J., Asznowiz, R., et l (1977). Ltex gglutintion in ignosis of teril infetions, with speil referene to ptients with meningitis n septiemi. Amer. J. Clin. Pth., 68, Ksper, D.L., Winkelhke, J.L., et l (1973). Immunohemil similrity etween polyshrie ntigens of Esherihi oli 07:K1(L):NM n group B Neisseri meningitiis. J. Immunol., 110, Lee, C.J. n Koizumi, K. (1981). Immunohemil reltions etween pneumool group 19 n Klesiell psulr polyshries. J. Immunol., 127, Roins, J.B., Myerowitz, R.L., et l (1972). Enteri teri ross-retive with Neisseri meningitiis groups A n C n Diploous pneumonie types I n III. Infet. Immun., 6, Whittle, H.C., Tugwell, P., et l (1974). Rpi teriologil ignosis of pyogeni meningitis y ltex gglutintion. Lnet, ii, 619. Broniox is the registere tre nme of Cognis UK Lt. Minion is tre mrk of the Millipore Corportion. Mnufture y: Remel Europe Lt Clipper Boulevr West, Crosswys Drtfor, Kent, DA2 6PT UK IFU X7713B, Revise July 2014 For tehnil ssistne plese ontt your lol istriutor. Printe in the UK

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