1. , MAIN RESULTS INTEGRATION OF A RAPID TEST INTO FRENCH GUIDELINES IN ORDER TO IMPROVE TETANUS PROPHYLAXIS IN PATIENTS PRESENTING WITH WOUNDS TO EMERGENCY DEPARTMENTS. D. Elkharrat, P. Espinoza, J. de la Coussaye, G. Potel, JL. Pourriat & MJ. Sanson-Le Pors for the French Tetanus Prophylaxis Group, University-Hospital Ambroise Paré, Boulogne, France. INTRODUCTION AND MAGNITUDE OF THE PROBLEM In emergency departments (ED) worldwide, tetanus prophylaxis (TP) is unscheduled and, in over 65% of cases, aimed at patients presenting with accidental wounds. Medical compliance with TP guidelines is very low. Consequently, TP is mostly empirical mainly based on immunization history, of which patients are hardly aware. Until recently, the lack of a reliable test to predict in real time tetanus seroprotection of individuals, led to 30- 40% of inadequate TP, 17-30% of which were excessive and 5-10% consisted of underimmunization. In the latter group, more than 50% had a conjunction of tetanus-prone wounds and nonprotective antibody titers. These figures are particularly meaningful since 1 500 000 persons present annually to French EDs with an indication for unscheduled TP. The availability of a rapid, reliable test reflecting tetanus seroprotection has sharply increased TP accuracy. PURPOSE TO INCLUDE THE PERFORMANCES OF TETANOS QUICK STICK (TQS) - validated by 2 prospective french studies - into the current French Health Department TP Guidelines used for patients presenting with wounds to ED METHODS WHAT IS TETANOS QUICK STICK? IT IS RAPIDLY PREDICTIVE OF TETANUS IMMUNITY IN INDIVIDUALS 1. Tetanos Quick Stick (Gamma*) Detects specific antitoxins in blood (> 0.2 IU/ml), serum and plasma (> 0.1 IU/ml). - Principle: Tetanus toxoid conjugation in liquid/solid phases (figure 1). - How to perform TQS (figure 2). - Binary outcome: positive or negative (Photo) C window : Control reagent T window : Tetanus toxoid. C T Well : tetanus toxoid- dye conjugate Fig. 1. Principle of Tetanus Quick Stick 2. Serum antitoxin levels measurement by Elisa (Virotech*) - Specific IgG neutralizing tetanus toxins - Reading by optical density; outcome expressed in International Units per milliliter - 0.1IU/ml is considered non protective, requires complete vaccination - 0.5 IU/ml is protective; no TP required - 0.1 et < 0.5, intermediate; tetanus toxoid booster is advised. TWO LARGE SCALE STUDIES IN THE ED 1 CENTER IN 2000 (STUDY I), 39 CENTERS IN 2001 (STUDY II) ASSESSED RELIABILITY and FEASIBILITY of TQS in ED WORKING CONDITIONS BOTH ARE CONCORDANCE STUDIES SAME INCLUSION CRITERIA REFERENCE: SERUM ANTITETANUS LEVELS (SAL) SAL PERFORMED IN THE SAME LABORATORY Inclusion of patients (Stage C) Consecutive patients 24 h/7d With fresh (< 24 h.) wounds Age > 15 years Seroprotection measured by both techniques After signing informed consent Non inclusion: patients not interviewed, severe surgical wounds. End points In theory - TQS would read positive when SAL is > 0.1 IU/ml - TQS would be negative when SAL is 0.1 IU/ml - When doubtful for at least 1 reader, interpreted as negative Main end point: a rate of false positives close to 0 was expected Other end points: rate of false negatives under 10% Study conduct - Definitions: Sensitivity (Se) = true positives and Specificity (Sp) = true negatives - 1018 individuals in study I and 989 in study II were tested in a double blind fashion with TQS and SAL Preliminary Statistical analysis was applied only to patients with TQS and SAL tests. Included and non included patients did not differ for demography and wound types -- - : - STUDY I STUDY II Date 2000 2001 Inclusions 1018 989 Sex ratio (% M) 70,9 70,5 Age [Min-Max] 39,2 [16-94] 43,5[15-96] Sensitivity 82,8-90,4% 70-84% Specificity 97,3-100% 98-100% EXPERT CONSENSUS SIX PHYSICIANS 5 specialists of Emergency Medicine 1 of Microbiology (who coordinated SAL all measurments) AN ALGORITHM WAS DESIGNED After the 2 study coordinators were interviewed during 48 hours OBJECTIVE Insertion of TQS in the Health Ministry Guidelines To conduct in real time acurate TP in french EDs CONCLUSIONS TQS is reliable and easily performed by care providers. It is currently the most specific and sensitive tool for predicting in real time tetanus protection of patients presenting in ED with wounds. Its incorporation in European Guidelines would be useful in the better management of tetanus-prone wounds. Fig. 2. Photo