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Polyvalent human immunoglobulins for intravenous use (GVP) are obtained by fractionating human plasma with ethanol, according to a method in which traces of pepsin at pH4 eliminate any anticomplementary activity. All the analytical tests have come within official requirements. Results of extended tests concerning specificity, potency, immunoglobulin subclass distribution, biological half-life and opsonic function are presented. Since their official release for clinical use on July 1st, 1983, almost 15,000 therapeutic units of 2.5 g of immunoglobulins have been consumed without any reported major side effects. Multicenter clinical trials are being carried out with adults and children. Available results confirm very good tolerance, and, as expected, effectiveness for well known and codified indications.

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This paper presents an overview and history of the Groupamatic system from the original conception by C. Matte through the present Groupamatic 360-C and the Minigroupamatic. The report includes the results of a recent evaluation in which 79 centres throughout the world participated.

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The trypsin-polybren-citrate (TPC) technique is based on Lalezari's method and has been developed in the Groupamatic equipment to allow the screening of irregular allo-antibodies which are not detectable on this machine by the present routine techniques. TPC screening has two main advantages: it gives more reliable results for Rh, Kell, Lewis and P antibodies than bromelin-methyl-cellulose, and it permits the screening of Duffy and Kidd antibodies, However, although the TPC technique contributes to an improved quality of the automated screening of blood donor samples, it should not be used as the only method when recipient samples are concerned.

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Since it was opened 18 months ago, the blood donor sampling Center at Orsay has used traditional means of advertising. However, although the results were satisfactory for the first year, they soon levelled off; and it was decided to adopt another approach, in the form a promotion campaign, including posters, brochures, cartoons... The campaign "Vive la Vie" has been limited to the immediate vicinity of Orsay. It was set up in such a way to enable the staff to implement it easily and progressively and thus precisely follow and record the results. The data are reported in this article. The advantages of the system are a two-step appeal which allows more persuasive information to be given; a graduated approach welcoming both the convinced and the more reluctant donors to the Centre; and the compiling of an index by means of the forms returned by the population.

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These data comprise 1,231,024 routine tests carried out over a 5-year period on voluntary blood donors. The percentage of positive results on the machines varies from 1 to 3% of the total number of samples tested. Antibodies identified either by manual or automated techniques make up 15--20% of the positive screening reactions. Rhesus, Luewis and P systems prevail, whilst Duffy, Kidd and Ltheran systems are absent. This screening has three main advantages: the supply of plasma for our production of test sera, or therapeutic immunoglobulins; protection of the recipient; partial information on the donor's immunohaematological state, especially for the risk of giving him incompatible blood sometimes in the future.

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We report here the experience of 3 years of irregular antibody automated screening with Groupamatic, that is to say of 661,511 samples tested in Paris and 269, 162 samples tested in Toulouse. The positive reactions in Paris were 16,296 (2.46%) out of which 2,021 irregular antibodies were identified (0.30%). The positive reactions in Toulouse were 8,266 (3.07%) out of which 2,138 irregular antibodies were identified (0,79%). The difference between the number of screened positive reactions and the identified one is due to false positive reactions (half of the cases) and to autoantibodies whose number is roughly the same than the number of identified alloantibodies. During the years 1970, 1971 and 1972, the irregular antibodies were systematically screened in Toulouse on all blood donors with a manual technique on opaline plate using enzyme treated red cell tests (papain). 7,147 positive reactions were detected, out of 240,080 tests (2.98%). 1,954 (0,81%) were alloantibodies and 1,529 (0.64%) autoantibodies; 3.455 were false positive reactions and 209 were non identified antibodies. These figures are superimposed with those obtained with Groupamatic during the following years, thus pointing out the interest of this equipment.

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Some agglutination tests for HBs Ag and anti-HBs detection may be easily automated. Reverse hemagglutination, needing a lengthy incubation and several steps to carry out is unfit for Groupamatic, but hemagglutination inhibition and latex agglutination may be used. Hemagglutination inhibition using selected human red cells (ORh+) coated with cesium chloride purified HBs Ag, has been now routinely used at the C.N.T.S. with visual reading for almost 2 years. Negative and positive controls are necessary. The anti-HBs serum utilized has to be checked daily to get sensitive detection. Every new batch of coated red cells (valid 4 to 6 weeks) is checked in microtiter plates in the laboratory, before being used on Groupamatic. Both positive and dubious results are systematically retested in RIA. We found only 0,5% of false positive. The sensibility of the test compared favourably with other third generation test as reverse hemagglutination. It was close to the results obtained with radio-immuno-assay or enzyme-immuno-assay and it was more sensitive than counter-immuno electrophoresis. 65,472 samples were tested in parallel: we were able to detect 97% of HBs Ag detected by RIA. False negative results were less than 1 per 10 000 and may be avoided by using citrated solution for the anti-HBs serum dilution (suppression of auto-agglutination of the red cells). Antigex TG (the most active batch of latex coated with guinea pig, anti-HBs antibody) made by Pfizer, gave good results on Groupamatic and automatic reading was possible. But more results are necessary using various batches, before to recommend such reagent.

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The automatization of immunohematological tests on Groupamatic equipments and its integration in a data management system of blood units and donor files has been brought about progressively, takinginto account the initiator status of the C.N.T.S. and its priviliged relationship with the manufacturer. A set of different problems was thus successively studied, the solutions of which lead to the development of new techniques, concerning the machine itself and its surroundings: --blood collection: -taking of blood sample on vacutainers containing anti-coagulant, without dilution, at a constant level and clot free; --identification: -connection between blood sample and blood unit by the creation of an identification number on twin labels (2 part card); -donor blood donation connection; --utilization of Groupamatic results: -edition of result listings; -study and use of an automated labelling of blood units; --setting up and daily updating of donor files: -blood collection data management; -creation of a badge--link between blood donation, files and donors. These constant improvements of both system and techniques have helped to put us within reach of the goal set as early as 1963 with Dr. C. Matte, that is to say the establishment of a fully automated system avoiding any intervention other than blood collection. Thus, due to the suppression of retranscription, this system increases the safety and enables the use of previously known donor characteristics.

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The widespread utilization of Groupamatic equipment for routine immunohaematological tests has increased the demand for serological procedures that can be performed with this machine. We describe the test method which was developed and with which the detection of HBs antigen has now been carried out routinely for 1 year. It is an automated haemagglutination inhibition reaction which is called GIPHA (Groupamatic inhibition of passive haemagglutination). The sensitivity corresponds to 2 CNTS units, the antigen weight for 1 unit being from 1 to 4 ng. The reproducibility is good; the percentage of false positive reactions is about 0.5% and that of technical problems 0.7%. The additional advantages of the machines are numerous, among which we have the possibility of 11 other simultaneous reactions. One of them is the detection of antibodies against HBs antigen, which is a passive haemagglutination test called PHAG (passive haemagglutination on Groupamatic).

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