TGS TA HSV 1 IgG
Contents
1. If the calibrators have already been used the container will have a top cap red cap with no guarantee seal Remove the red closing cap before placing them in the analyser Place the calibrators in the samples area of the analyser see the analyser user manual on how to identify them in the analyser Bar code data must be entered manually if the label is damaged or if it is unreadable The readings for the IgG anti HSV 1 antibody concentration in the calibrators are recorded in the DATA DISK and automatically transferred to the analyser At the end of the session the calibrator containers must be closed with the top caps red caps provided and stored at 2 8 C until they are used again The calibrators can be used for a maximum of four times Loading of controls Place the controls in the samples area of the analyser See the analyser user manual on how to identify them in the analyser If there is no bar code on the control or if it is not readable the control identification data must be entered manually If TGS TA Controls are used see the instructions for use provided The readings for the IgG anti HSV 1 antibody concentration in the TGS TA controls are recorded in the DATA DISK and automatically transferred to the analyser Select the required parameters for each control Loading of samples Place the samples in the samples area of the analyser see the analyser user manual on how to identify them in the analyser If there is no bar2. TGS TA HSV 1 IgG REF YB500028 REF YB500028 BS Tesa in m TGS TA HSV 1 IgG M RN 3 INSTRUCTIONS 8 C 7 J FOR USE IVD A 100 INTENDED USE The TGS TA HSV 1 IgG test is a chemiluminescent immunoassay CLIA for quantitative determination using TGS TA Analyser or IDS iSYS Multi Discipline Automated System instrumentation of specific IgG class antibodies directed against the Herpes Simplex Virus type 1 HSV 1 in samples of human serum or plasma EDTA Sodium Citrate This assay is used as a diagnostic aid when assessing HSV 1 infections This product must be used in strict compliance with the instructions given in this document by professional users CAUTION Medical decisions must not be based exclusively on the result of this test but must take into account all available clinical and laboratory data as a whole CLINICAL SIGNIFICANCE Type 1 and 2 Herpes Simplex viruses HSV 1 HSV 2 belong to the Herpesviridae family in the Alphaherpesvirus subfamily and both are human pathogens They are large sized viruses 150 200 nm with a linear double stranded DNA Their distribution is ubiquitous and inter human transmission is direct from an infected individual to a susceptible individual Approximately one third of the population are hosts to the latent form of the virus and are sources of infection in periods of productive activation of the virus HSV infections are cl
3. HSV 1 The samples used were subdivided as follows 3 HSV 2 34 EBV VCA 33 EBV NA 3 EBV EA 26 CMV 38 VZV The study did not show any significant cross reaction between the solid phase antigen and the other antibodies Saturation effect at high doses Some immunological methods used to determine samples containing the analyte at extremely high concentrations may supply apparent levels of underestimated analyte Hook effect The method used in the TGS TA HSV 1 kit since it uses two incubations is not subject to this effect A sample with an extremely high concentration above the measurement range of anti HSV 1 IgG confirmed the absence of the hook effect up to the concentration of 912 UA mL Relative Sensitivity and Specificity The presence of anti HSV 1 IgG antibodies was determined using the TGS TA HSV 1 IgG kit and an immunochemiluminescence assay available on the market in 179 samples 9 samples gave rise to discordant results between the TGS TA assay and the other available method The relative concordance was therefore found to be 95 0 95 Confidence Interval 90 4 97 5 170 179 The relative sensitivity was found to be 94 4 95 Confidence Interval 88 8 97 4 134 142 The relative specificity was found to be 97 3 95 Confidence Interval 84 2 99 9 36 37 IFUO038TGS TA Version 02 15 September 2014 Page 13 di 14 TGS TA HSV 1 IgG REF YB500028 BIBLIOGR
4. code on the sample or if it is not readable the sample identification data must be entered manually Select the required parameters for each sample Calibration The TGS TA Analyzer instrument uses a memorised calibration curve master curve generated by the manufacturer for each lot of reagent cartridges IFU038TGS TA Version 02 15 September 2014 Page 7 di 14 TGS TA HSV 1 IgG REF YB500028 The master curve parameters together with the calibrator concentration settings are stored in the DATA DISK and transferred to the instrument s database Calibrators A and B are used to recalibrate the master curve in both for the instrument used and for the reagents on board To recalibrate analyse three replicates of the two calibrators A and B and one replicate of each control The concentration obtained with the controls make it possible to validate the new calibration Once recalibration of the master curve has been accepted and stored in memory all subsequent samples can be analysed without any further calibration except in the following cases when a reagent cartridge with a new lot number is loaded into the instrument when the controls do not fall within the range of acceptability after instrument maintenance when the validity of the recalibrated master curve has expired The validity of the recalibrated master curve for the TGS TA HSV 1 IgG kit is 21 days R
5. 14 TGS TA HSV 1 IgG REF YB500028 The Calibrator concentrations are expressed in UA mL arbitrary units and calibrated against an internal reference standard The concentration settings specific for each production lot are recorded on the DATA DISK included in the kit DATA DISK A Mini DVD containing data regarding all the products in the TGS TA line Reagents Calibrators Control Sera updated to the last production lot with the exclusion of products that have expired at the date when the new DATA DISK was compiled Only the DATA DISK with the highest lot number needs to be kept to maintain the information required for correct operation of the system up to date Materials and reagents required but not supplied in the kit TGS TA Analyzer 120 Cod No TGS00001 TGS TA Cuvette Cube Code No Pack of 960 cuvettes TGS TA System Liquid Code No 1 bottle containing 5 liters of ready to use solution TGS TA Wash Solution Code No 1 bottle containing 10 liters of ready to use solution TGS TA Trigger Set Code No 1 250 mL bottle of Trigger A pre trigger solution 1 250 mL bottle of Trigger B trigger solution TGS TA D SORB Solution Code No Pack of 2 bottles containing 1 liter of ready to use solution TGS TA Cartridge Checking System Code No TGS TA ImmunoCleaner Code No 6 bottles each containing 27 mL TGS TA Top Cap Set Code No 300 red top caps t
6. APHY 1 Xu F Sternberg MR Kottiri BU et al Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States JAMA 2006 296 964 973 PubMed 16926356 2 Chayavichitslip P Buckwalter JV Krakowski AC Friedlander SF Herpes Simplex Pediatr Rev 2009 30 4 119 29 3 Centers for Disease Control and Prevention Sexually transmitted diseases treatment guidelines 2002 MMWR 2002 51 No RR 6 4 Lamey Pj Hyland PL Changing epidemiology of herpes simplex type 1 infections Herpes 199 6 20 24 5 Nieuwenhuis RF van Doorum Gj Mulder PG et al Importance of herpes simplex virus type 1 HSV 1 in primary genital herpes Acta Derm Venereol 2006 86 129 134 PubMed 16648915 6 Lycke E and Jeansson S Herpes Simplex Virus in EH Lenette P Halonen and FA Marphy eds Laboratory Diagnosis of Infectious Diseases Principals and Practice vol Il Viral Rickettsial and Clamydial diseases Springer Verlag Berlin pp211 1988 7 Drew WL and Rawls WE Herpes simplex viruses in EH Lenette A Ballows WJ Hausler and HJ Shadomy eds Manual of Clinical Microbiology 4 ed American Society for Microbiology Washington DC pp 705 1985 8 Arvin A C Prober Herpes Simplex Virus 876 883 In Murray P E Baron M Pfaller F Tenover and R Yolken eds Manual of Clinical Microbiology 6 Ed ASM Washington D C 1995 9 Bergstr m T Trybala E Antigenic differences between HSV 1 and HSV 2 glycoproteins and their i
7. The components of the reagent cartridge must not be removed from the cartridge and reassembled Do not use the kit after its use by date REAGENT PREPARATION The reagents supplied in the kit are all ready for use REAGENT STORAGE AND STABILITY Store the reagents supplied in the kit at 2 8 C in a vertical position in a dark place In these conditions unopened reagent cartridge and calibrators are stable until the expiry date After opening the reagent cartridge can be used for 60 days if kept in a refrigerator at 2 8 C or in the analyser After opening the calibrators can be used for 60 days if kept in a refrigerator at 2 8 C and if they have not been left in the analyser for more than 6 hours per session Do not freeze the reagents and calibrators SAMPLE PREPARATION AND STORAGE The assay must be performed on samples of human serum and plasma EDTA Sodium Citrate Use of lipaemic haemolysed and turbid samples is not recommended If the assay is performed after more than 8 hours separate the serum or the plasma from the clot from the red blood cells and transfer the supernatant from the gel separating tubes to the secondary tubes Before being analysed samples may be kept in a refrigerator at 2 8 C for a maximum of 7 days If the assay is to be performed after more than 7 days store the samples frozen lt 20 C Avoid repeated freezing and thawing OPERATING PROCEDURE Carefully follow the instruc
8. assed as primary and recurrent and are highly prevalent in the population HSV 1 is normally associated with infections in the oropharyngeal and eye areas while HSV 2 is the cause of most genital and neonatal infections Tissue specificity is not however absolute HSV 2 may be isolated even if only occasionally from the oropharyngeal area and approximately 10 20 of primary genital infections can be caused by HSV 1 Primary HSV 1 infections generally occur during infancy in the first 5 years of life when susceptible individuals come into close contact for example by a kiss with individuals parents relatives etc who are eliminating the virus Adolescents who have not been infected during infancy generally contract the infection in the same way Primary HSV 2 infections prevalently occur by sexual intercourse and the moment of contagion generally takes place at the beginning of sexual activity that is from adolescence to young adulthood IFU038TGS TA Version 02 15 September 2014 Page 1 di 14 TGS TA HSV 1 IgG REF YB500028 Laboratory diagnosis of HSV 1 and HSV 2 infections began to become an increasingly more important part of treatment of patients from when increasingly effective possible treatment Acyclovir Valaciclovar and Farmiciclovir became available WHO Meeting 1991 Diagnostic techniques include isolation of the virus by PCR which permits both genomic quantity detection and geno
9. e 11 di 14 TGS TA HSV 1 IgG REF YB500028 Measured Expected Re over Sample Dilution factor concentration concentration of y UA mL UA mL i 1 282 6 100 1 2 3 In any case it must be stressed that non all the sera when measured at differing dilutions are able to provide linear results with the measurable range since the result depends not only on the concentration but also on the affinity of the antibodies present in the sample Analytical Sensitivity The analytical sensitivity of the TGS TA HSV 1 IgG kit was assessed using a protocol based on the guidelines given in Clinical and Laboratory Standards CLSI document EP17 A In one case referred to as the Limit of Detection LoD that is the smallest quantity of analyte that the method is able to measure the formula for calculating LoD LoB Cg SD in which LoB is the Limit of Blank SD is the estimated standard deviation of the distribution of the sample at low concentration and Cg is derived from 95 percentile of the standard Gaussian distribution was applied Five low concentration samples of analyte were used determined singly with one batch of reagents in 16 different tests The Limit of Detection of the TGS TA HSV 1 IgG kit proved to be 7 4 UA mL In the other protocol calculation of the Minimum Detectable Concentration MDC is envisaged 20 replicates of the solution of the 0 UA mL Standard of the Maste
10. ecalibration management is handled automatically by the analyser Assay Press the start button 1 The system aspirates 100 uL of Sample Diluent 20 uL of Magnetic Particles 100 uL of Sample Diluent and 6 uL of sample or control for the calibrators the positive serum is supplied prediluted with Sample Diluent and the volume aspirated is 106 uL The aspirated solutions and suspension are dispensed into the reaction cuvette The reaction cuvette is incubated in the rotor at 37 C for 10 minutes After this phase of incubation the magnetic particles are separated and washed 200 uL of conjugate are dispensed into the cuvette The reaction cuvette is incubated in the rotor at 37 C for 10 minutes oa F wD After this last phase of incubation the magnetic particles are separated and washed and the cuvette is transferred to the reading chamber 7 The quantity of conjugate bonded to the solid phase expressed in RLU is directly proportional to the concentration of anti HSV 1 IgG present in the sample 8 The readings obtained are interpolated on the calibration curve and transformed into concentrations Samples with concentration higher than the upper limit of the measurable range can be diluted and retested The new value obtained is multiplied to obtain the final result by the dilution factor used QUALITY CONTROL To ensure the validity of the assay control sera at differing levels of concentration at least one negative se
11. ed light The system calculates the assay results for the samples and controls by means of a stored calibration curve and prints a report that includes all the information related to the assay and to the patient MATERIALS AND REAGENTS Materials and reagents supplied Magnetic particles coated with recombinant gG1 HSV 1 antigen in Phosphate Buffer containing stabilising proteins surfactant Pro Clin 300 and sodium azide lt 0 1 as preservatives Mouse Monoclonal anti human IgG antibody labeled with an acridinium ester derivative conjugate in Phosphate Buffer containing stabilising proteins surfactant Pro Clin 300 and sodium azide lt 0 1 as preservative Sample Diluent Solution Phosphate Buffer containing bovine serum albumin a surfactant an inert blue colouring agent Pro Clin 300 and Gentamicin SO as preservatives Human serum with low concentration of anti HSV 1 IgG antibodies in Phosphate Buffer containing bovine serum albumin a surfactant an inert blue colouring agent Pro Clin 300 and Gentamicin SO as preservatives Human serum with high concentration of anti HSV 1 IgG antibodies in Phosphate Buffer containing bovine serum albumin a surfactant an inert blue colouring agent Pro Clin 300 and Gentamicin SO as preservatives All reagents are ready for use Reagents 1 2 and 3 are assembled in a single reagents cartridge unit IFUO038TGS TA Version 02 15 September 2014 Page 3 di
12. ference with in vitro immunological dosages Such samples may give rise to anomalous readings if analysed with the TGS TA HSV 1 IgG kit EXPECTED VALUES 38 selected non immune samples have been analysed to check absence of anti HSV 1 IgG antibodies All samples analysed proved negative with a mean value of 1 80 UA mL and a standard deviation of 1 77 UA mL Using the results obtained the Limit of Blank LoB the highest reading value that can be expected in a series of samples that do not contain the analyte was calculated The Limit of Blank determined as 95 percentile of the negative population is equal to 3 8 UA mL with one Reagent lot PERFORMANCES Caution the data presented do not represent the operating specifications of the kit but serve as experimental proof of how the kit works within these specifications in the manner envisaged by the manufacturer Precision and Reproducibility The precision and the reproducibility of the TGS TA HSV 1 IgG kit have been assessed using a protocol based on the guidelines given in Clinical and Laboratory Standards CLSI document EP5 A2 The precision was calculated by analysing the results of 20 replicates of four sera one negative and three positive with differing concentrations of anti HSV 1 IgG performed with two different lots of reagents in the same test run The concentration of the negative anti HSV 1 IgG H1G N7 serum gave results from 1 0 to 1 9 UA mL and fro
13. ic anti HSV 1 IgG employs an indirect two step immunological method based on the principle of chemiluminescence The specific antigen is used to coat the magnetic particles solid phase and an anti human IgG antibody is labelled with an acridinium ester derivative conjugate During initial incubation the specific antibodies present in the sample in the calibrators or in the controls bond with the solid phase During the second incubation the conjugate reacts with the anti HSV 1 IgG antibodies captured by the solid phase After each incubation the material that has not bonded with the solid phase is removed by aspiration and subsequent washing The quantity of labelled conjugate that remains bonded to the solid phase is assessed by activation of the chemiluminescence reaction and measurement of the light signal The generated signal expressed in relative light units RLU is indicative of the concentration of specific antibodies present in the sample in the calibrators and in the controls AUTOMATION The TGS TA Analyser instrument automatically performs all the operations envisaged by the assay protocol addition of samples calibrators controls magnetic particles conjugates and chemiluminescence activation IFU038TGS TA Version 02 15 September 2014 Page 2 di 14 TGS TA HSV 1 IgG REF YB500028 solutions to the reaction cuvette magnetic separation and washing of particles measurement of the emitt
14. ically corrected according to the responses obtained for calibrators assay results For detailed information on how the system calculates the results please see the analyser user manual Interpretation of the results The measurement range of TGS TA HSV 1 IgG is 0 0 426 UA mL Values lower than 0 0 UA mL are extrapolated values the message OMR and or ORA appears and they are shown as equal to 0 0 UA mL Values higher than 426 UA mL are accompanied by the message OMR and or ORA and may retested after suitable dilution The results of the samples may be interpreted in the following way UA mL Interpretation lt 10 The sample must be considered to be Negative for anti HSV 1 IgG 2 10 The sample must be considered to be Positive for anti HSV 1 IgG The values reported above are indicative only Each laboratory will establish its own reference intervals IFUO038TGS TA Version 02 15 September 2014 Page 9 di 14 TGS TA HSV 1 IgG REF YB500028 LIMITS TO THE ASSAY METHOD For diagnostic purposes the results obtained with the TGS TA HSV 1 IgG kit and the TGS TA Analyser system must be used together with the other clinical and laboratory data available to the physician Bacterial contamination of the sample and heat inactivation may influence the result of the dosage Heterophilic antibodies present in human serum samples may react with immunoglobulin based reagents causing inter
15. m 1 8 to 2 5 UA mL with reagent lots nos 2 and 3 The table shows the results obtained with the 3 positive sera IFUO038TGS TA Version 02 15 September 2014 Page 10 di 14 TGS TA HSV 1 IgG REF YB500028 Average Sample die hale Sones tiation SD CV UA mL R E e e 32 6 o Sk nd SA ee 3 36 3 1 17 3 2 E ee 2 ee m S 3 119 2 5 31 4 5 2 225 5 13 00 5 8 3 sca as 300 gt aor Jeee E EROA The reproducibility was calculated by analysing the results of the determination of four sera one negative and three positive with differing concentrations of anti HSV 1 IgG performed in single replicate in 16 different sessions with two lots of reagents The concentration of the negative anti HSV 1 IgG H1G N6 serum gave results in the range from 0 4 to 1 0 UA mL The table shows the results obtained with the 3 positive sera Average SD Sample concentration UA mL CV UA mL 1 70 8 5 87 8 3 2 118 0 7 96 6 7 3 215 7 13 39 6 2 Linearity of the Dilutions The linearity of the TGS TA HSV 1 IgG kit was assessed using a protocol based on the guidelines given in Clinical and Laboratory Standards CLSI document EP6 A Serial dilutions performed by using the System Liquid of 3 sera with high concentrations of anti HSV 1 IgG were dosed The results of this study are summed up in the table below IFUO038TGS TA Version 02 15 September 2014 Pag
16. mportance for type specific serology Intervirology 1996 39 3 176 84 TECHNOGENETICS S r l Via Vanvitelli 4 20129 Milano Italy IFU038TGS TA Version 02 15 September 2014 Page 14 di 14
17. o close the calibrator containers after first use IS CC1000 IS CS1000 IS CW 1000 IS CT1000 YC500009 IS 601000 YC500012 YC500010 IFUO038TGS TA Version 02 15 September 2014 Page 4 di 14 TGS TA HSV 1 IgG REF YB500028 Manufactured by IDS France SAS 42 rue St phane Mazeau 21320 Pouilly en Auxois France and distributed by Technogenetics Srl Manufactured by Immunodiagnostic Systems S A Rue E Solvay 101 B 4000 Li ge Belgium and distributed by Technogenetics Srl Other Recommended Reagents TGS TA HSV 1 2 IgG CONTROL SET Cod No YB500031 Three 1 5 mL vials of negative human serum and three 1 5 mL vials of human serum positive for anti HSV 1 antibodies WARNINGS AND PRECAUTIONS The reagents supplied in the TGS TA HSV 1 IgG kit are only for in vitro diagnostic use and not for in vivo use in humans or animals This product must be used in strict compliance with the instructions given in this document by professional users Technogenetics cannot be held responsible for any losses or damages caused by use not in conformity with the instructions supplied Safety precautions This product contains material of animal origin and therefore must be handled as if it contains infecting agents This product contains components of human origin All units of serum or plasma used to produce the reagents in this kit have been analysed with FDA approved methods and found not to be reac
18. r curve were used The average and the standard deviation SD were formulation on a lot of the kit The RLU value related to the average 2 6 SD was interpolated on the curve and the related concentration was obtained from this value The analytical sensitivity expressed as the Minimum Detectable Concentration is 0 6 UA mL The minimum detection values together with considerations of a clinical kind and the results of comparison with reference methods contributed to the definition of the cut off value Analytical Specificity Interferences A study based on the guidelines given in the CLSI document EP7 A2 has shown that the dosage performances are not influenced by the presence in the sample of the potentially interfering substances listed in the table below up to the tested concentration IFU038TGS TA Version 02 15 September 2014 Page 12 di 14 TGS TA HSV 1 IgG REF YB500028 e ote rt ally Iterrening Maximum tested concentration Substances Free bilirubin 20 mg dL Conjugated bilirubin 20 mg dL Haemoglobin 1000 mg dL Triglycerides 3000 mg dL Use of lipaemic haemolysed and turbid samples is not in any case recommended Analytical Specificity Cross reactions In order to assess potential cross reactions of the antigen used to sensitise the microparticles a study was conducted using 137 samples all with IgG antibodies positive for Herpes antigens and TORCH and IgG antibodies negative for
19. rum and one positive serum must be measured every day in which dosage is performed If individual laboratory practice so dictates more frequent or more numerous controls may be performed for verification of assay results Follow local quality control procedures IFU038TGS TA Version 02 15 September 2014 Page 8 di 14 TGS TA HSV 1 IgG REF YB500028 If TGS TA control sera are used the expected average concentration and the acceptability limits are those given on the DATA DISK included in the control set pack too If different control sera are used before using them the values expected with TGS TA reagents and system must be defined If the control values does not fall within the specified range of acceptability the related assay results are not valid and the respective samples must be analysed again In this case before repeating the tests a recalibration procedure must be performed CALCULATION AND INTERPRETATION OF THE RESULTS Calculation of the results The concentration of the anti HSV 1 IgG present in the samples that are being tested is automatically calculated by the system The results can be viewed on the display or printed The concentrations are expressed in UA mL Calculation of the analyte concentration in the sample takes place by interpolating the response obtained for each sample on a calibration curve calculated in accordance with a 4 parameter logistic fitting 4PL Y weighted period
20. tions given in the user manual of the instrument to obtain reliable analytical results Loading of reagents All the reagents supplied in the kit are ready for use Before inserting the reagent cartridge in the system the magnetic particle container must be horizontally agitated by rotation in order to ensure correct resuspension of the particles Avoid generating foam when performing this operation IFUO038TGS TA Version 02 15 September 2014 Page 6 di 14 TGS TA HSV 1 IgG REF YB500028 Place the reagent cartridge in the reagent area of the instrument using the rack provided and leave it to be agitated for at least 40 minutes before use Positioning of the reagent cartridge simultaneously determines reading of the identification bar code If the cartridge label is damaged or if it is not readable the reagent cartridge identification data can be entered manually The instrument automatically maintains the magnetic particles constantly agitated If the reagent cartridge is removed from the instrument store it at 2 8 C in a vertical position in a dark place Loading of calibrators TGS TA calibrators are ready for use Leave the calibrators at room temperature for 10 minutes and then gently shake the contents either manually or using a vortex avoiding the formation of foam When using the calibrators for the first time remove the guarantee seal and the white sealing cap before placing them in the analyser
21. tive due to presence of HBsAg anti HCV anti HIV1 and anti HIV2 However since no analysis method is able to guarantee the absence of pathogenic agents all material of human origin must be considered to be potentially infected and handled as such In the event of damaged packaging or accidental leakage decontaminate the area concerned with a diluted solution of sodium hypochlorite after putting on suitable personal protective equipment overall gloves goggles Dispose of the material use for the clean up and of the packaging involved in the leakage according to national regulations for disposal of potentially infected waste In the event of damaged packaging or accidental leakage do not use the reagents to perform the assay Some reagents contain sodium azide as a preservative Since sodium azide may react with lead copper and leaded brass forming explosive azides in piping it is recommended that reagents or waste are not poured down drains but are disposed of in compliance with the national regulations on disposal of potentially hazardous waste IFUO038TGS TA Version 02 15 September 2014 Page 5 di 14 TGS TA HSV 1 IgG REF YB500028 Operating precautions Reliable results can only be obtained by strictly complying with these instructions and scrupulously following what is written in the operating manual for the instrument The reagents supplied in the kit must be used only with the TGS TA Analyzer system
22. type classification and the IFA test as well as serological assay which can prove useful for diagnosing primary HSV infections and for determining evidence of previous infections Diagnosis of primary infections is based on detection of specific IgM class antibodies as well as to demonstrate seroconversion or a significant increase in the concentration between acute and convalescent sera Serological assay proves less useful for diagnosis of recurring HSV infections since such infections often are not reflected in modified levels of antibodies Many serological tests offered on the market use purified viral lysates Given that the cross reaction between the two HSV serotypes is highly significant use of these viral lysates does not permit correct differentiation between HSV 1 and HSV 2 Since most adult individuals have been infected with HSV 1 often if clinical symptoms are absent the anti HSV 2 immune status is difficult to assess The use of recombinant membrane glycoproteins specific for the type of virus makes it possible to distinguish exactly the patient s immune status The specific recombinant glycoproteins are gG1 for the type 1 virus and gG2 for the type 2 virus They are used both to monitor the primary infection by detecting the specific IgM antibodies and the patient s immune status by detecting the specific IgG antibodies PRINCIPLE OF THE METHOD The TGS TA HSV 1 IgG kit for quantitative determination of specif
Download Pdf Manuals
Related Search