Application Experience and Skills of Automatic Enzyme Exemption Instrument

Application Experience and Skills of Automatic Enzyme Exemption Instrument

Shanghai Yueyan Biotechnology Co., Ltd.

The enzyme-linked immunosorbent assay (ELISA) has been widely used in hospital laboratories due to its advantages of simple operation, reliable technology, and convenient reagents. Especially since the 1990s, the sensitivity and specificity of ELISA and the degree of automation of the detection process have been significantly improved and improved. ELISA has thus become a serology for detecting infectious diseases (viral hepatitis, AIDS, etc.), tumor markers and The main technology of various clinical immune indicators such as endocrine.
With the rapid development of laboratory medicine, ELISA will be more involved in diagnosis, treatment and efficacy judgment. Its technology has evolved from manual, semi-automatic, and fully automatic to multi-functional, multi-purpose combined production lines. Various laboratories are popular in the world. In view of the above, our hospital purchased an ALISEI automatic enzyme-free analyzer from Italy SEAC in December 2002, equipped with Shanghai Kehua ELISA reagent. After one year of use, observation and comparison, the experience is as follows:

1. Test program editing

The English control software provided by ALISEI can facilitate users to program each test item easily and specifically according to its operation instructions, and can edit the pre-dilution work before testing; and flexibly adjust the operation steps appropriately (eg: For the detection of HEV-IgM and HEV-IgG kits provided by Shanghai Kehua Company, only 50μl of serum is added when HEV-IgM is added, and 100μl of sample dilution and 10μl of serum are required when HEV-IgG is added. The Disp Regent + ┄ function enables 100μl of sample diluent and 10μl of serum to be completed in one step, so that the operation steps of the above two detection items are consistent and can be tested on the same microplate). In addition, for two test items with similar operation steps, users can use the COPY function to copy a source program and modify it slightly to obtain a program similar to the source program step, which simplifies the editing of the operation program.

Another example is the hepatitis B two-and-a-half detection reagent produced by Shanghai Kehua Co., Ltd. (for immediate reading): If the laboratory ’s hepatitis B two-and-half detection amount is less than 44 servings on the day, it will occupy three plates of ALISEI; if it is more than 44 For serving, it takes up five boards of ALISEI. The author copied the HBsAg detection program into HBsAg1, HBsAg2, HBsAg3, and carried out artificial assembly, that is, HBsAg-HBsAb was one board, HBeAg-HBsAg1 was one board, etc., and it was assembled into four boards, so that it could occupy four ALISEI boards On the basis of the same batch, the test of up to 68 servings of hepatitis B in two and a half.

Second, the detection flow chart

After starting up every day, users add patient data according to the amount of specimens of the day, the software is automatically edited, time optimization management is performed, and TMS (time management system) maps are finally generated. But sometimes the flow chart provided by TMS does not satisfy users. Users can use the SWAP (position interchange) function provided by the software to exchange the detection serial numbers of the corresponding test items in order to expect a satisfactory TMS chart. Therefore, it is recommended that when editing the test program, the sequence number of the test item with tedious steps is higher.

3. Prevent cross contamination

Tested by the Beijing Medical Device Quality Supervision and Inspection Center of the State Administration of Drug Administration: ALISEI's design carry pollution rate <1ppm, actual carry pollution rate <0.1ppm [1].
In the recent period, it was found that the background of the first and second slats of the HBsAg two-and-a-half HBsAg test plate in the daily test results was high. After careful observation of the daily time to optimize the management band, it was found that the instrument added a needle to dispense the anti-HCV enzyme-labeled secondary antibody, and then the HBsAg developer was assigned. The author doubts whether trace contamination is caused by the strong adhesion of the anti-HCV enzyme-labeled secondary antibody. The author then slightly modified the operation steps against HCV: that is, after adding the enzyme-labeled secondary antibody, inserting a two-step washing solution perfusion and rinsing the injection needle procedure. After testing, it was found that the problem of high background of the first and second slats of the HBsAg two-and-a-half HBsAg detection plate has been solved.

Of course, the author believes that if the inserted two-step perfusion and rinsing needle procedure is changed to the first step of stopping fluid perfusion and rinsing, and the second step of washing fluid perfusion and rinsing, the effect will be more clear. From the above experiment, we can find that as the inspector, we should not stick to the inherent operation mode of the automatic analyzer, and we should give play to the subjective initiative of the person, so that the machine can better serve people.

Four, reading system

ALISEI uses the most advanced 8-fiber three-wavelength reading to remove all interference including microplate scratches during the test, making the results more accurate and reliable. The maximum linear range OD value can reach 9.0.

V. Test items

In addition to qualitative tests, ALISEI can also do quantitative tests, affinity tests, allergen detection, etc.

6. Deficiencies

1. ALISEI provides 6 boards and 12 projects online testing at the same time, but it is insufficient for laboratories carrying out more than 12 projects testing. The factory has listened to the requirements of the majority of users and made corresponding changes in the newly provided control software version: 6 boards and 16 items can be provided for online detection at the same time.

2. Due to some current testing items (for example, rheumatoid factor typing test), OPD (o-phenylenediamine) is required for color development, and OPD color developing solution has poor stability and needs to be temporarily prepared and needs to be applied within half an hour; And ALISEI is fully closed when working. If such items are detected by ALISEI, it is necessary to suspend the instrument in the middle and put the color developing liquid, which will cause a lot of trouble.

In summary, the introduction of the ALISEI automatic enzyme-free instrument can not only improve work efficiency, but also save labor, make the quality management of enzyme-free tests more standardized, and improve the precision, sensitivity, and specificity of ELISA. Realize the automation and network of enzyme-free laboratory.

references:
[1] ALISEI automatic enzyme-free analyzer quality test: W (X-040-2001). Beijing Medical Device Quality Supervision and Inspection Center of the State Drug Administration.

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