A new rapid semi-quantitative enzyme immunoassay suitable for determining immunity to tetanus (original) (raw)
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Journal of biological standardization, 1983
Antibodies to tetanus toxin were induced in sheep by hyperimmunization over 24 weeks. Bleeds taken at weeks 4, 8, 20 and 30 were assayed for antibody titre by both an enzyme immunoassay (EIA) using a newly-described urease enzyme/substrate system and by bioassay in mice. There was a very good correlation between the two assay systems and, with the exception of the week 4 Bleeds, the relationship was the same at all stages of hyperimmunization regardless of titre, adjuvant, or whether toxin or toxoid was used as immunogen or for coating the plates. The results establish that the EIA can replace the bioassay for the determination of tetanus antitoxin in ovine sera.
Journal of Biological Standardization, 1984
A micro ¢nzyme-linkeM immunosor|£×-n~ assay has [~-en adaptcx| to the quantiration of SpeclfiC tetanus antita~Aies in commercial preparations of human immunoEalobulins. The rest,|ts of t|,e a~say arc compared with those obtained from the same sample, testc:d by seroneutra|izaltion ecs~s m l'iw,~ Statistical analysis of the data shows g~xl ¢orwlation bc.twtx.n the ti¢R's obtained with the two tests.~ Re,~,lrs obtair*,ed by indirect haema~*~.h~tinarion are ;dso ~lmrred it is pro,~d that all interested |abor;Itories i~ri;-)rm the de~#crib~ immum~<-naymatic meth~| iz, vitro for a given IX'ri~| in |x~rai|e| with tile zn ~ t~.*¢ to gain ~t,fliclent ex|~-rience of this technique with a view to its use ~ an Mternative ¢o the m v~,~. t~.t.
Quantification of tetanus antitoxin in human sera. 1. Counter-immunoelectrophoresis
Apmis, 1979
An extensive sero-epidemiological survey of immunity to tetanus is to be performed in Norway during 1978 and 1979 and thus a simple and reliable method for screening sera for content of tetanus antitoxin is needed. An improved counter-immunoelectrophoretic method for quantification of tetanus antitoxin is described. The toxin neutralization test in mice is considered to correlate well with protection in humans. Counter-immunoelectrophoresis has the advantage of using tetanus toxoid instead of toxin, as well as being more rapid and less expensive. Specific antibodies of the IgG, IgM, and IgA classes could be read simultaneously for many sera. This may be of importance, since it is reported in the literature that only antibody of the IgG class is capable of neutralizing tetanus toxin in mice. Counter-immunoelectrophoresis is limited by being less sensitive than the toxin neutralization test in mice.
Tetanus Quick Stick as an applicable and cost-effective test in assessment of immunity status
American Journal of Emergency Medicine, 2011
Introduction: Tetanus vaccine and immunoglobulin administration are challenging decisions mostly because of the fact that the current protocol for immunization against tetanus is based on 2 variables: the vaccination status of the patient and the nature of wound and its exposure. To solve this problem, Tetanus Quick Stick (TQS; Nephrotek Laboratory, Rungis, France), an immunochromatographic dipstick test, was developed to determine the tetanus immunity of the patients. The aim of this present study was to investigate the sensitivity, specificity, and the positive and negative predictive values and cost-effectiveness of TQS in the emergency department (ED) setting. Methods: Blood samples were collected from 200 patients presenting to our ED. Information including demographic information, tetanus immunization status, wound description, and the preventive measures taken by the emergency physician were gathered by a preeducated nurse. Tetanus Quick Stick test and enzyme-linked immunosorbent assay were performed as the standard diagnostic test by an emergency physician and a laboratory technician, respectively; and results of the 2 techniques were compared. Result: Overall, tetanus vaccine was administered to 141(70.5%) patients and immunoglobulin to 105 (52.5%) patients. The analysis revealed 88.1% sensitivity and 97.6% specificity for the TQS test. The positive and negative predictive values of TQS test were 99.3% and 66.1%, respectively. Our analysis is also showed a significant decrease in cost when TQS was applied for patients with dirty, tetanus prone wounds or injuries and unknown or incomplete vaccination history (€ 9.48 versus € 12.1). Conclusion: This study revealed TQS test to be appropriate and cost-effective for ED use especially in evaluating patients who do not remember or cannot give their tetanus immunization history.
Clinical and Vaccine Immunology, 2008
Accurate determination of the concentrations of immunoglobulin G (IgG) antibody to tetanus toxoid is important in order to evaluate the immunogenicity of tetanus toxoid vaccines, determine immune competence in individual patients, and measure the prevalence of immunity in populations. The performance of three commercially available enzyme-linked immunosorbent assays (ELISAs) for IgG antibodies to tetanus toxoid were evaluated. Serially diluted NIBSC 76/589 and TE-3 human tetanus IgG immunoglobulin international reference standards were analyzed in quadruplicate using ELISAs manufactured by The Binding Site, Inc. (VaccZyme); Scimedx; and Euroimmun. In addition, IgG antibodies to tetanus toxoid were measured in 83 deidentified serum specimens using each manufacturer's ELISA. Each ELISA provided linear results when evaluated with the reference preparations. The Binding Site ELISA provided results that closely corresponded to the reference preparations ( y = 1.09 x − 0.08), whereas ...
Diagnosis of tetanus immunization status: multicenter assessment of a rapid biological test
Clinical and Vaccine …, 2005
Diagnosis of tetanus immunization status by medical interview of patients with wounds is poor. Many protected patients receive unnecessary vaccine or immunoglobulin, and unprotected patients may receive nothing. The aim of this study is to evaluate the feasibility and accuracy of the Tetanos Quick Stick (TQS) rapid finger prick stick test in the emergency department for determining immunization status. We designed a prospective multicenter study for blinded comparison of TQS with an enzyme-linked immunosorbent assay (ELISA). Adults referred for open wounds in 37 French hospital emergency departments had the TQS after receiving standard care (emergency-TQS). TQS was also performed in the hospital laboratory on total blood (blood/lab-TQS) and serum (serum/lab-TQS). ELISA was performed with the same blood sample at a central laboratory. We assessed concordance between emergency-TQS and blood/lab-TQS by the kappa test and the diagnostic accuracy (likelihood ratios) of medical interview, emergency-TQS, and lab-TQS. ELISA was positive in 94.6% of the 988 patients included. Concordance between blood/emergency-TQS and blood/lab-TQS results was moderate (؍ 0.6), with a high proportion of inconclusive blood/emergency-TQS tests (9.8%). Likelihood ratios for immunization were 3.0 (95% confidence interval [CI], 1.8 to 5.1), 36.6 (95% CI, 5.3 to 255.3), 89.1 (95% CI, 5.6 to 1,405.0), and 92.7 (95% CI, 5.9 to 1,462.0) for medical interview, blood/emergency-TQS, blood/lab-TQS, and serum/lab-TQS, respectively. The sensitivity of the blood/emergency-TQS was 76.7%, and the specificity was 98% by reference to the ELISA. TQS use in the emergency room could make tetanus prevention more accurate if its technical feasibility were improved, and our assessment will be supplemented by a cost effectiveness study.
Background: In patients with wounds admitted to Emergency Departments (ED) acquiring tetanus vaccination history by interview is very unreliable. Protected patients may receive unnecessary prophylaxis and unprotected nothing. Aim of the study was to evaluate tetanus immunity status comparing the traditional anamnestic method with the Tetanus Quick Stick (TQS), a rapid immunochromatographic test. Methods: A double-blind prospective study was carried out in the ED of the 1,000 bed teaching hospital Umberto I in Rome. Adult patients (≥18) with wounds attending at the ED were randomly included. Tetanus immunity status was evaluated by healthcare workers (HCWs) comparing the TQS test with the anamnesis. TQS test was performed by a trained HCW and afterwards the anamnesis about tetanus immunity status was collected by another HCW unaware of the TQS result. Also cost analysis was carried out. Results: Overall 400 patients (242 males and 158 females) were included, mean age was 46.7 ± 20.2 years (median 44 range 18 – 109), 304 (76.0%) were italians and 96 foreigners (24.0%). Overall, 209 (52.2%) resulted TQS +, and protective immunity level was associated to lower mean age (40.1 ± 16.8 vs 53.8 ± 21,1; p<0,01). Using the anamnestic method 336 (84.0%) patients resulted " unprotected " , 52 (13.0%) " partially unprotected " and 12 (3.0%) " completely protected ". TQS test results showed that 154 (45.8%) out of 336 " unprotected " and 45 (86.5%) out of 52 " partially unprotected " actually had a protective antibody level. Finally two (16.7%) out of 12 " completely protected " group presented a non protective antibody level. Following only the anamnestic method 201 (50.0%) patients would have received some inappropriate treatment. Adopting TQS test in all patients would also be cost-effective saving € 1.95/patient. As tetanus immunity is inversely related to age, for <51 years old patients unnecessary treatment would have been avoided in 57.1% of patients, with a mean reduction per patient of € 7.50/patient with the TQS vs. € 12.69/ patient without. Conclusion: The study showed that tetanus protective immunity prevalence among adult patients attending our ED is about 50% and is mainly influenced by class age. TQS use allowed to reduce drastically inappropriate tetanus vaccine and immunoglobulins booster treatment. Also TQS use reduced costs.
Annali di igiene: medicina preventiva e di comunità
and unprotected nothing. Aim of the study was to evaluate tetanus immunity status comparing the traditional anamnestic method with the Tetanus Quick Stick (TQS), a rapid immunochromatographic test. Methods: A double-blind prospective study was carried out in the ED of the 1,000 bed teaching hospital Umberto I in Rome. Adult patients (≥18) with wounds attending at the ED were randomly included. Tetanus immunity status was evaluated by healthcare workers (HCWs) comparing the TQS test with the anamnesis. TQS test was performed by a trained HCW and afterwards the anamnesis about tetanus immunity status was collected by another HCW unaware of the TQS result. Also cost analysis was carried out. Results: Overall 400 patients (242 males and 158 females) were included, mean age was 46.7 ± 20.2 years (median 44 range 18 -109), 304 (76.0%) were italians and 96 foreigners (24.0%). Overall, 209 (52.2%) resulted TQS +, and protective immunity level was associated to lower mean age (40.1 ± 16.8 vs 53.8 ± 21,1; p<0,01). Using the anamnestic method 336 (84.0%) patients resulted "unprotected", 52 (13.0%) "partially unprotected" and 12 (3.0%) "completely protected". TQS test results showed that 154 (45.8%) out of 336 "unprotected" and 45 (86.5%) out of 52 "partially unprotected" actually had a protective antibody level. Finally two (16.7%) out of 12 "completely protected" group presented a non protective antibody level. Following only the anamnestic method 201 (50.0%) patients would have received some inappropriate treatment. Adopting TQS test in all patients would also be cost-effective saving € 1.95/patient. As tetanus immunity is inversely related to age, for <51 years old patients unnecessary treatment would have been avoided in 57.1% of patients, with a mean reduction per patient of € 7.50/patient with the TQS vs. € 12.69/ patient without. Conclusion: The study showed that tetanus protective immunity prevalence among adult patients attending our ED is about 50% and is mainly influenced by class age. TQS use allowed to reduce drastically inappropriate tetanus vaccine and immunoglobulins booster treatment. Also TQS use reduced costs.
American Journal of Biomedical Sciences, 2009
Conventionally, for estimation of potency of tetanus toxoid by Antibody Induction Method (AIM), two doses (1/10 th of single human dose/dose) of tetanus toxoid given on 0 th and 28 th day, injected subcutaneously into guinea pigs has been recommended. But this assay has a serious drawback of 'booster effects' as the animal is immunized on two occasions besides usage of large number of animals. Hence, feasibility of using single dilution given at single occasion was assessed. For this a three dilution regime was used wherein three dilutions of the standard and test tetanus toxoid (TT) were injected subcutaneously into guinea pigs. Postimmunization sera were raised at 4 th and 6 th week and titrated by in-vivo Toxin Neutralization Test (TNT) done in mice and in-vitro indirect enzyme-linked immunosorbent assay (ELISA). For TNT, L+/10 doses of toxin combined with different concentrations of serum samples were inoculated into mice for anti-tetanus antitoxin detection. It was found that if the animal was bled at 4 th week post-immunization, anti-tetanus antibody titers as shown by ELISA were 4-5 times higher than the titers estimated by TNT while at 6 th week ELISA and TN titers were comparable (r 2 =0.999). When the time of bleeding, post-immunization, was increased from 4 th to 6 th week, a 5 fold increase in neutralizing antibody titer was seen. Also, standardized ELISA was found to be of high validity and can be used as an alternate for evaluation of anti-tetanus neutralizing antibodies, thus permitting the in-vitro evaluation of the tetanus antitoxin. Moreover, besides saving mice, ELISA saves five days required for TNT and the pressure on the laboratory is significantly reduced.
Measurement of tetanus antitoxin II. Toxin neutralization
Journal of Biological Standardization, 1980
Measurement of tetanus antitoxin" II. Toxin neutrM zatton Margaret Existing meth~s for tlt~tlon of tetanus antitoxin fa/I to provide ~q accurate and sensitive t~hnlque for conducting ~says on small ~lumes of sera~ The need For Such a t~hnique ~ r~ si~e in th~ ~rts of the world where tetanus is a p~bM~, tE~ collation of~uate serum ~mples is usually al~ a p~blem. The toxin ~utr~aizatinn method de~ri~ ~rmits dt~tion of tet~us a~xtitoxin in twofoM dilutMn steps frorr~ ~ 4item ~s 0"001 AJJ¢%I, If the titration includes the |o~*er limit oft~ ran~ ofantltoxin units to ~ tested~which differs ~cordlng ¢o the toxin test down-the volume of~rum ~uired ~ 0"6 mL For m~t anti~ta, however, the toxin test do~ and ra.n~,~: of serum dilutions for testing can ~ thorn, on the basis of titres determined by inditer hae~ag$1utina~ion~ VJ that dilutions |~om m~ initiM serum dilution of 1:2 ~ill suite ~'hich reigns d~at *only 0" 3 ml o~mf~a~ is ~quired. By mtticting the range of ~m diiutMns for testing) prlo¢ titratMn of tetanus anti~oxln by inditer haemagg|utlnacMn aL~<) axx~id~ the need t~r large num~ o~ mice that the titr~i0n ofa two~Jid ~ries by toxin neutra|i~ti~n would otherwi~ entail *~m mer~r.J is ~'simpie and ~onomlcai and the restait~ obtains] are accurate and repr~d~cible provide~| tP~at no sign ~ficant variat ion occurs in the ~'~o,Jy ~,eight of t|~e tnice.