Package Insert - Sekisui Diagnostics
Contents
1. B Doerr HW 2002 Seroprevalence of herpes simplex virus types 1 and type 2 in the Frankfurt am Main area Germany Med Microbiol Immunol 190 153 160 11 Roizman B DM Knipe 2001 Herpes Simplex Viruses and Their Replication In Fields B D Knipe P How ley et al eds Fields Virology 4 Ed Lippincott Raven Philadelphia 12 Smith J N Robinson 2002 Age specific prevalence of infection with herpes simplex a global review J Inf Dis 186 3 28 13 Tunback P Bergstr mT Claesson BA Carlsson RM L w hagen GB 2007 Early acquisition of herpes simplex virus type 1 antibodies in children A longitudinal serological study J Clin Vir 40 26 30 14 Whitley R 2001 Herpes Simplex Viruses In Fields B D Knipe P How ley etal eds Fields Virology 4 Ed Lippincott Raven Philadelphia 15 Wutzler P Doerr HW Farber Eichhorn U Helbig B Sauerbrei A Brandst dt A Rabenau HF 2000 Seroprevalence of herpes simplex virus type 1 and type 2 in selected German populations relevance for the incidence of genital herpes J Med Virol 61 201 207 Seite 10 von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 12 Test Procedure Scheme Preparation of Patient Samples and Washing Solution V Washing Solution Fill up concentrate to 1 liter with aqua dest demin y IgG Samples Dilution y IgM Samples Dilution 1 101 1 101 Rheumafactor absorption with RF SorboTech e g e g 10 ulserum plasma 12. aE ar AA ar ae Eaa AAE a ETERRA 5 8 2 Preparation of Reagents E E E T 5 8 3 Virotech E SA Test PrO edO e e r a a EE a aa a aa vat a a Aa a arana Aaaa Aa ARa AE n e a aa e e eaa herren 6 8 4 Usage of ELSA PrOCESSOTSH 2 222 002 a A a a na A EA E due EAE A AS ENA A 6 9 Test OECO a a E ASS ee Se 6 92 Test Oa entog ketolp 1 Ae MAAE E A ideal an ie E E E A ede 9 2 Calculation of the Virotech Units VE 9 3 Interpretation Scheme IgG and lgM sete al OA Limits OF THE TOSty accvs se E ATEN SETAT EEIE estan hasdessiesne saa henes E ETAT ESTRRENTEETERFEET TEN 10 Performance Data 2 aaa a aa a Aa e Eaa a a Aa cot Ea aeara A EAEE 7 10 1 Analytic sensitivity And SpecPiCiy Assie near nn 10 2 Prevalence expected values 10 3 Intra assay Coefficient of Variation Repeatability 10 4 Inter assay Coefficient of Variation Reproducibility 11 Literature SE ee ee Ae acest eee eee 9 12 Test Procedure Sche Me i sc araa a a a a paaa aa eaa aaa a sees Aa aa aa AA aa aaaea A Aaa ia 11 Seite 2von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 1 Intended Use The HSV 1 gG1 resp the HSV 2 gG2 ELISA is intended for the semiquantitative and qualitative detection of specific IgG IgM antibodies against Herpes simplex Virus HSV type 1 resp type 2 in human serum The serology is suitable for the detection of the immune status and as Herpes exclusion The use of t
3. ell Shake plate carefully and thoroughly until liquid is completely mixed and a homogeneous yellow color is visible 10 Measure extinction OD at 450 620nm Reference Wavelength 620 690nm Set your photometer in such a w ay that the blank value is deducted fromall other extinctions Extinctions should be measured within 1 hour after adding the stopping solution o N OOO PB Pls refer to last page for Test Procedure Scheme 8 4 Usage of ELISA processors All Sekisui Virotech ELISAs can be used on ELISA processors The user is bound to proceed a validation of the devices processors on a regular basis Sekisui Virotech recommends the follow ing procedure 1 Sekisui Virotech recommends to proceed the validation of device referring to the instructions of the device manufacturer during the implementation of the ELISA processor respectively after bigger reparations 2 It is recommended to check the ELISA processor with the Validationkit EC250 00 afterw ards A regular check using the Validationkit shall be proceeded minimum once a quarter to test the accuracy of the processor 3 The release criteria of the Quality Control Certificate of the product must be fulfilled for each testrun With this procedure your ELISA processor will function properly and this will support quality assurance in your laboratory 9 Test Evaluation The ready to use controls serve for asemiquantitative determination of specific IgG and IgM antibodies Their
4. preservative in Tris Buffer ready to use Tetramethylbenzidine s ubstrate solution 3 3 5 5 TMB 11ml ready to use Citrate Stopping Solution 6ml contains an acid mixture OOS OD EINEN OR ee SEID _ _ A D N 5 Storage and Shelflife of the Testkit and the ready to use reagents Store the testkit at 2 8 C The shelf life of all components is show n on each respective label for the kit shelf life please see Quality Control Certificate 1 Microtiter strips single w ells are to be resealed in package after taking out single w ells and stored w ith desiccant at 2 8 C Reagents should immediately be returned to storage at 2 8 C after usage 2 The ready to use conjugate and the TMB substrate solution are sensitive to light and have to be stored in dark Should there be a color reaction of the substrate dilution due to incidence of light it is not useable anymore 3 Take outonly the amount of ready to use conjugate or TMB needed for the test insertion Additional conjugate or TMB taken out may not be returned but must be dismissed Material Status Storage Shete Test Samples Diluted 210 8C Undiluted 210 48 Seite 4von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 2 to 8 storage in the provided bag w ith desiccant bag 3 months Microtitreplate After Opening Rheumatoid factor Undiluted After Opening 2 to 8 C Absorbent Diluted 2 to 8 C Conjugate Aft
5. 000 ul Dilution Buffer 5 ul serum plasma 450 ul Dilution Buffer Serum Dilution Buffer is ready to use 1 drop RF SorboTech incubate for 15 min at room temperature Testprocedure Samples Incubation 30 minutes at 37 C 100 pl Patient Samples blank value Dilution Buffer and controls Wash 4times 400 ul Washing Solution Remove Residues on a Cellulose Pad Conjugate Incubation 30 minutes at 37 C 100 ul Conjugate IgG IgM Wash 4times 400 ul Washing Solution Remove Residues on a Cellulose Pad Substrate Incubation 30 minutes at 37 C 100 ul Substrate Stopping 50 ul Stopping Solution shake carefully Measure Photometer at 450 620nm Extinctions Reference Wavelength 620 690nm Seite 11 von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014
6. HSV 1 gG1 ELISA recombinant HSV 2 gG2 ELISA affinity purified IgG IgM Testkit Order No HSV 1 9G1 EC130 00 HSV 2 gG2 EC131 00 Color Coding HSV 1 gG1 red black HSV 2 gG2 red dark blue FOR IN VITRO DIAGNOSIS ONLY Sekisui Virotech GmbH Lowenplatz 5 65428 Russelsheim Germany Tel 49 6142 6909 0 Fax 49 6142 966613 http www sekisuivirotech com ce Druckdatum 03 02 2014 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Contents 1 Intendedi Use 2 2 4 4222 22220228200 ea AE 3 2 Diagnostic Relev nce 2zu 22u 1 zeua seen asecwebisivewccessteue cd savedbeyieewccasstewecdsveeweedcteteeveeeutens 3 3 Test Principle 22 22 2 testes A seeccctesceec fee teevtitdedecctetdecndueceevtitdedeaten i ceeveibehevtiiie eae ceeeiins 4 4 Package Contents IgG and IgM TeStKit ccccceeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeseeeeeeneeeeeneeenanees 4 5 Storage and Shelflife of the Testkit and the ready to use reagent uuuesnnnnnnnnnnnnnnnnnnnnnnnnnnn 4 6 Precautions ANd Warnings ursrnnsnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn anne nn nn nenn nun mennun nennen nenn 5 7 Material required but not supplied uussnssnnsnnnennnnnnnennnnnnnnnnnnnnnenn nennen anne nnnnennn nennen nennen 5 8 Test Procedure nennir SEEROENEEREEEHEEEEFEFFEFEERECHESEEEEFEEEEEFFEERERECHEEIEFECESELEEENEETERECHEREERECEREER 5 8 1 Examination Material e nen asien Eaa ar a A Eaa A
7. al is the prerequisite for obtaining correct results 8 1 Examination Material Either serum or plasma can be used as test material even if only serum is mentioned in the instructions Any type of anticoagulant can be used for plasma Alw ays prepare patient dilution freshly For a longer storage the sera must be frozen Repeated defrosting should be avoided 1 Only fresh non inactivated sera should be used 2 Hyperlipaemic haemolytic microbially contaminated and turbid sera should not to be used false positive negative results 8 2 Preparation of Reagents The Sekisui Virotech System Diagnostica offers a high degree of flexibility regarding the possibility to use the dilution buffer washing solution TMB citrate stopping solution as well as the conjugate for all parameters and for all different lots The ready to use controls positive control negative control cut off control are parameter specific and only to use with the plate lot indicated in the Quality Control Certificate 1 Set incubator to 37 C and check proper temperature setting before start of incubation 2 Bring all reagents to room temperature before opening package of microtiter strips 3 Shake all liquid components w ell before use Seite 5von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 4 Make up the washing solution concentrate to 1 L with distilled or demineralised w ater If crystals have formed in the concentrate please bring th
8. concentration canbe expressed in Virotech units VE Fluctuations resulting from the test procedure can be balanced with this calculation method and a high reproducibility is achieved in this w ay Use the means of the OD values for calculation of the VE 9 1 Test function control a OD values The OD of the blank should be lt 0 15 The OD values of the negative controls should be low er than the OD values mentioned in the Quality Control Certificate The OD values of the positive controls as w ellas of the cut off controls should be above the OD values mentioned in the Quality Control Certificate b Virotech Units VE The Virotech Units VE of the cut off controls are defined as 10 VE The calculated VE of the positive controls should be within the ranges mentioned in the Quality Control Certificate Seite 6von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 If those requirements OD values VE are not fulfilled the test has to be repeated 9 2 Calculation of the Virotech Units VE The extinction of the blank value 450 620nm has to be subtracted from all other extinctions OD positive control x VE positive control OD cut off control OD patient serum VE patient serum OD cut off control 9 3 Interpretation Scheme IgG and IgM Re V ji _ Resut V Evaluation 30 110 1 If the measured values are above the defined borderline range they are considered to be p
9. d 12 82 1 72 5 70 in Netherlands 13 Potentially cross reactive sera EBV VZV Measles Parvo CMV and sera of pregnant women do not show an increased percentage of positive sera compared to the blood donors This confirms the excellent specificity of the assays HSV 1 gG1 IgM The follow ing table show s the results obtained w ith the Sekisui Virotech ELISA for selected sera collectives Sera Collective Positive with the VT ELISA in Blood donors n 120 EEE o hinter Oo O Prostitutes sera n 40 oO Pregnantwomen s sera n 62 _ 0 HSV 2 gG2 IgG The following table shows the results obtained with the Sekisui Virotech ELISA for selected sera collectives The epidemiological data described in the literature are listed in comparison Sera Collective positive with the VT Literature Statements Seite 8 von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 po O san 15 in Germany 15 Blood donors n 120 59 14 18 in Germany 10 19 in Switzerland 6 1 5 year old lt 2 Infants sera n 39 6 11 year old lt 3 11 16 year old approx 8 12 78 in Germany 10 Pr 2 a en 49 in Switzerland 8 Seb ivemn Crossreactive sera n 39 Pregnant women s sera n 51 Potentially cross reactive sera EBV VZV WERE Parvo CMV show an identical percentage of positive sera compared to blood donors sera Sera of pregnant w omen show a low er percen
10. e concentrate to roomtemperature before use and shake w ell before use 5 High IgG titer or rheumatoid factors may disturb the specific detection of IgM antibodies and may lead to false positive resp false negative results For acorrectlgM determination it is therefore necessary to pre treat the sera with RF SorboTech VIROTECH adsorbent For IgM controls a pre absorbent treatment is not necessary 8 3 Virotech ELISA Test Procedure 1 For eachtestrun pipette 100ul each of ready to use dilution buffer blank IgG and IgM positive negative and cut off controls as w ell as diluted patient sera We propose a double insertion blank controls and patient sera for cut off controla double insertion is absolutely necessary Working dilution of patient sera 1 100 e g 10ul serum 1ml dilution buffer After pipetting start incubation for 30 min at 37 C with cover End incubation period by w ashing microtiter strips 4 times w ith 350 400ul w ashing solution per w ell Do not leave any w ashing solution in the w ells Remove residues ona cellulose pad Pipette 100ul of ready to use conjugate into each well Incubation of conjugates 30 min at37 C withcover Stop conjugate incubation by w ashing 4 times pls refer to point 3 above Pipette 100ul of ready to use TMB into each well Incubation of substrate solution 30 min at 37 C with cover keep in dark Stopping of substrate reaction pipette 50ul of citrate stopping solution into each w
11. er Opening 2 to 8 C protect from light Tetramethylbenzidine After Opening 2 to 8 C protect from light Stop Solution After Opening 2 to 8 C l After Opening 2 to 8 C See 6 Precautions and Warnings 1 Only serawhich have been tested and found to be negative for HIV 1 antibodies HIV 2 antibodies HCV antibodies and Hepatitis B surface antigen are used as control sera Nevertheless samples diluted samples controls conjugates and microtiter strips should be treated as potentially infectious material Please handle products in accordance with laboratory directions 2 Those components that contain preservatives the Citrate Stopping Solution and the TMB have an irritating effect to skin eyes and mucous If body parts are contacted immediately w ash themunder flow ing water and possibly consult a doctor 3 The disposal of the used materials has to be done according to the country specific guidelines 7 Material required but not supplied Aqua dest demin Eight channel pipette 50ul 100 Micropipettes 10ul 100ul 1000uI Test tubes Paper tow els or absorbent paper Cover for ELISA plates Disposal box for infectious material ELISA handw asher or automated EIA plate w ashing device ELISA plate spectrophotometer w avelength 450nm reference length 620nm Reference Wavelength 620 690nm Incubator gt 020010 Ons es Oe NN 8 Test Procedure Working exactly referring to the Sekisui Virotech user manu
12. f highly purified HSV 1 and HSV 2 lysate antigens in the VT HSV Seite 3von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 screening test this testsystemprovides a very suitable screening test for the CSF diagnosis of HSV infections of the CNS as it is highly sensitive A broad spectrumof highly purified HSV antigens is used in the VT HSV screen This not only leads to the desired high sensitivity but also to the equally desirable specificity w ith respect to differentiation from CNS infections with other neutrotropic pathogens of the herpes virus group We therefore recommend that the antibody index Al should initially be determined in Herpes simplex diagnostic testing w ith the HSV Screen ELISA lf there is the additional aim of achieving differentiation betw een HSV1 and HSV2 after detection of an HSV CNS infection this can be achieved with the help of the two species specific gG1 and gG2 ELISA tests Limits The level of pathogen specific antibodies against the gG1 or gG2 epitopes in the CNS at the time when the CSF sample is taken may still or already be too low to increase the Al Therefore if the gG1 or gG2 test is performed alone this may give a false negative result in some cases or in specific cases meaning that the antibody index is neither not calculable or is normal 3 Test Principle The antibody searched for in the human serum forms an immune complex w ith the antigen coated on the microtiter pla
13. gs effects of acyclovir JGen Virol 67 1601 1612 4 Brown ZA Benedetti J Ashley R Burchett S Selke S Berry S Vontver LA Corey L 1991 Neonatal herpes simplex virus infection in relation to asymptomatic maternal infection at the time of labor N Engl J Med 324 1247 1252 5 Brown Z S Sleke J Zeh J Kopelmann A Maslow R Ashley D Watts S Berry M Herd L Correy 1997 The acquisition of herpes simplex virus during pregnancy N Engl J Med 337 509 515 6 Bunzli D Wietlisbach V BarazzoniF Sahli R Meylan PR 2004 Seroepidemiology of Herpes Simplex virus type 1 and 2 in Western and Southern Switzerland in adults aged 25 74 in 1992 93 a population based study BMC Infect Dis 4 http www biomedcentral com 1471 2334 4 10 7 CDC 1998 Guidelines for Treatment of Sexually Transmitted Diseases MMWR 47 1 118 Seite 9von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 8 Eng BR Lippelt L Lorentzen EU HafeziW Schlumberger W Steinhagen K K hn JE 2002 Evaluation of confirmatory strategies for detection of type specific antibodies against herpes simplex virus type 2 J Clin Microbiol 40 407 413 9 Prober C W Sullender L Yasukawa DAu A Yaeger A Arvin 1987 Low risk if herpes simplex virus infections in neonates exposed to the virus at the time of vaginal delivery to mothers w ith recurrent herpes simplex virus infections N Engl J Med 316 240 244 10 Rabenau HF Buxbaum S Preiser W Weber
14. he type specific glycoproteins G gG1 resp gG2 enables the differentiation betw een HSV 1 and HSV 2 to determine the seroprevalence to identify potential virus carrier and for the risk calculation and prevention of the Herpes neonatorum The IgM result must not be observed isolated from the IgG result The diagnosis of the genital herpes must be confirmed w ith the pathogen detection The serology is not suitable for the detection of new born Herpes as the immune system of a baby is not completely developed at the date of its birth How ever itcan be usedin retrospect to measure the transplacentally transferred anti HSV 2 IgG antibodies 2 Diagnostic Relevance Herpes simplex viruses are widely spread throughout the population The transmitted results fromdirect contact w ith infected secretions fromeither asymptomatic or an asymptomatic host Therefore the contamination starts already in the early child age How ever these primary infections remain asymptomatical in over 90 of the cases a latent infection is established in the regional ganglia as a rule For the understanding of the pathogenesis of HSV infection the fact that latent persistent viruses in the ganglia cells may be reactivated is of important meaning The further spreading of the virus is favourabled by the asymptomatical virus expression throughout saliva and genital secretion In the orafacial area the HSV1 infections prevail whereas in the genital area the infections are most
15. ly caused by HSV 2 Only a small part 5 30 is generated by HSV 1 11 14 One of the most serious consequences of genital herpes is neonatal herpes 2 Without therapy mortality for untreated infants w ho develop disseminated infection exceeds 70 with half of the survivors developing neurological impairment 14 Almost all neonate HSV 2 infections are acquired by passage through an infected birth canal 7 Most mothers 60 80 whotransmit HSV to their children are asymptomatic at delivery 14 Transmission rates are much higher when the mother is experiencing a primary or initial genital infection 50 14 versus a recurrent infection lt 5 4 5 9 CDC recommends that prevention of neonatal herpes should emphasize the prevention of acquisition of genital HSV infection during late pregnancy Susceptible women whose partners have oral or genital HSV infection or those whose sex partners infection status is unknown should be counseled to avoid unprotected genital and oral sexual contact during late pregnancy 7 Viral isolation direct fluorescent antibody DFA testing and serology can be used to diagnose HSV infections Disadvantages of the first two methods are how ever length of culture time specimen collection and transport difficulties procedural complexity and other variables that are associated w ith DFA and culture 1 7 How ever due to the significant cross reactivity betw een HSV 1 and HSV 2 the serological assa
16. nd compared with an Immunoblot able to differenciate gG1 and gG2 specific 9G1 HSV 1 specific ELISA Virotech Analytic Finding HSV 1 and HSV 1 negative HSV 2 Immunoblot IgG able i HSV 1 positive 3 206 to differenciate 27 sera show ing borderline results with the reference system or the ELISA have not been considered Thus an analytic sensitivity of 98 6 and an analytic specificity of 98 9 have been calculated Seite 7von 11 REV 13 HSV 1 gG1 HSV 2 gG2 ELISA IgG IgM GB Druckdatum 03 02 2014 HSV 2 gG2 346 sera have been tested in IgG and compared with an Immunoblot able to differenciate gG1 and gG2 specific gG2 HSV 2 specific ELISA Virotech Analytic Finding HSV 1 and HSV 2 negative HSV 2 lot 1 DAR ar 3 124 to differenciate 18 sera show ing borderline results w ith the reference system or the ELISA have not been considered Thus an analytic sensitivity of 97 6 and an analytic specificity of 99 0 have been calculated 10 2 Prevalence expected values HSV 1 gG1 IgG The following table shows the results obtained with the Sekisui Virotech ELISA for selected sera collectives The epidemiological data described in the literature are listed in comparison Sera Collective positive with the VT Literature Statement ELISA in 80 in Germany 15 Blood donors n 120 71 7 75 in Germany 10 80 in Sw itzerland 6 30 1 5 year old Infant sera n 39 33 3 50 12 16 year ol
17. ositive 2 lf the measured VE is within the borderline range no significant high antibody concentration is present the samples are considered to be borderline For the secure detection of an infection it is necessary to determine the antibody concentration of tw o serumsamples One sample shall be taken directly at the beginning of the infection and a second sample 5 10 days later convalescent serum The antibody concentration of both samples has to be tested in parallel that means in one test run A correct diagnosis based on the evaluation of a single serum sample is not possible 3 lf the measured values are below the defined borderline range no measurable antigen specific antibodies are present in the samples The samples are considered to be negative 4 in case of a positive IgM result a review of the result by observing the course of the IgG titer is recommended 9 4 Limits of the Test 6 The interpretation of serological results shall always include the clinical picture epidemiological data and all further available laboratory results 7 Despite all advantages of the gG2 assay there exist also notes tow ards the limits of the test On one hand the therapy with Acyclovirdie may influence the antibody development 3 and on the other hand the genetic variability of the gG2 protein may lead to gG2 negative HSV 2 strains 10 Performance Data 10 1 Analytic sensitivity and specificity HSV 1 gG1 325 sera have been tested in IgG a
18. tage of positive sera compared to blood donors sera This confirms the excellent specificity of the assays HSV 2 gG2 IgM The follow ing table show s the results obtained w ith the Sekisui Virotech ELISA for selected sera collectives Sera Collective Positive with the VT ELISA Blood donors n 120 10 3 Intra assay Coefficient of Variation Repeatability In one assay strips of different plates of one batch have been tested in a chessboard pattern with two sera The obtained coefficients of variation for IgG for HSV 1 gG1 and HSV 2 gG2 are lt 15 10 4 Inter assay Coefficient of Variation Reproducibility Three sera were tested in 10 independent test runs on three different testdays The obtained variation coefficient values for HSV 1 gG1 and HSV 2 gG2 are lt 15 11 Literature 1 Anzivino E D Fioriti M Mischitelli A Bellizzi V Barucca F Chiarini V Pietropaolo 2009 Herpes simplex virus infection in pregnancy and in neonate status of art of epidemiology diagnosis therapy and prevention VirolJ 6 40 2 Arvin A C Prober 1995 Herpes Simplex Viruses 876 883 In Murray P E Baron M Pfaller F Tenover and R Yolkenet eds Manual of Clinical Microbiology 6 Ed ASM Washington D C 3 Bernstein DI LR Stanberry CJ Harrison JC Kappes MG Myers 1986 Antibody response recurrence patterns and subsequent herpes simplex virus type 2 HSV 2 re infection following initial HSV 2 infection of guinea pi
19. te Unbound immunoglobulins are removed by washing processes The enzyme conjugate attaches to this complex Unbound conjugate is again removed by washing processes After adding the substrate solution TMB a blue dye is produced by the bound enzyme peroxidase The color changes to yellow when the stopping solution is added 4 Package Contents IgG and IgM Testkit 1 Microtiter Plate consisting of 96 with antigen coated breakable single w ells lyophilised PBS Dilution Buffer blue readyto use 2x50mI pH 7 2 with preservative and Tw een 20 PBS Washing Solution 20x concentrated 50m1 pH 7 2 w ith preservative and Tw een 20 IgG negative Control 1300pl human serum w ith protein stabilizer and preservative ready to use IgG cut off Control 1300yl human serum w ith protein stabilizer and preservative ready to use IgG positive Control 1300yl human serum w ith protein stabilizer and preservative ready to use IgM negative Control 1300p human serumw ith protein stabilizer and preservative ready to use IgM cut off Control 1300pl human serumw ith protein stabilizer and preservative ready to use IgM positive Control 1300pl human serumw ith protein stabilizer and preservative ready to use IgG Conjugate anti human 11ml sheep or goat horseradish peroxidas e conjugate with protein stabilizer and preservative in Tris Buffer ready to use IgM Conjugate anti human 11ml sheepor goat horseradish peroxidase conjugate with FCS and
20. ys that use virus lysates as antigens are not sufficiently suited to differentiate HSV 1 infections from HSV 2 infections Due to the high contamination w ith HSV 1 the serological status for HSV 2 can be detected hardly reliable w ith such methods 14 Intrathecal IgG antibodies occur only 8 10 days after the clinical symptoms in a present Herpes encephalitis IgM antibodies are not regularly developed but if so it is in short term appearance and in very low concentration This means the serology can be used as a confirmatory tool of the clinical diagnosis retroactively The genital HSV 1 infections recurrent considerably more rarely than HSV 2 infections A previous infection w ith genital HSV1 seems to give a certain protection of infections with HSV 2 respectively allays the symptoms or entirely prevent them 10 A previous oral HSV 1 infection does not protect against a genital HSV 2 infection 14 The clinical picture of genital herpes corresponds those of other ulceration of the sexual organs and has therefore to be differentiated against Haemophilus durcreyi Treponema pallidum and Chlamydia trachomatis 7 Herpes simplex CSF diagnosis In contrast to the serological diagnosis of HSV infections w hat is most important in CSF diagnosis is the reliable detection of endogenous synthesis of pathogen specific antibodies in the CNS rather than any differentiation betw een the pathogen species HSV 1 and HSV 2 As a result of the combination o
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