Microbial diagnostic market analysis

The field of microbiological diagnosis in China started late, with a share of about 5%, an increase of about 10%. Microbial diagnosis provides a basis for the prevention, diagnosis, treatment and observation of clinical infectious diseases through etiological diagnosis and drug sensitivity analysis. In the past two years, in the field of microbial detection, the industry ’s biggest impact has been the matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF) and the technological breakthroughs in the precision and rapidity of drug sensitivity detection.

Although the mass spectrometry market is still dominated by bioMérieux and Brooke, domestic mass spectrometers continue to develop rapidly and break through the monopoly of foreign companies at a lower price based on guaranteed performance. At present, microbial detection is developing in two directions.

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The method for detecting viral antigens and antibodies in body fluids of HIV-infected persons is convenient to operate and easy to popularize and apply, in which antibody detection is particularly common. However, the status and importance of HIv P24 antigen and viral genes in the detection of HIV infection have also received increasing attention.

(1) Antibody detection

There are mainly enzyme-linked immunosorbent assay (ELISA) and immunofluorescence test (IFA). ELISA uses detergents to lyse HIV or infected cell fluid extracts as antigens, and IFA uses infected cell smears as antigens for antibody testing. If a positive specimen is found, it should be repeated once. To prevent false positives, Western blot (WB, Western blot) can be used for further confirmation.

The WB method uses polyacrylamide gel electrophoresis to separate HIV proteins, and then transfers different protein bands to nitrocellulose membrane by transfer electrophoresis. After adding patient serum to incubate, staining with anti-human globulin standard antibody can detect Antibodies against different structural proteins, such as anti-gp120, gp41, and P24 antibodies, have high specificity.

(2) Antigen detection

The P24 antigen was detected by ELISA. When the antibody did not appear in the early stage of HIV infection, the antigen was present in the blood. Because the amount of P24 is too small, the positive rate is usually low. Existing methods of dissociated immune complexes or concentrated P24 antigens are used to increase sensitivity.

(3) Nucleic acid detection

Detection of HIV genes by PCR method has the advantages of rapid, high efficiency, sensitivity and specificity. Medical education network collection | collation. At present, this method has been applied to the early diagnosis of HIV infection and AIDS research.

(4) Virus isolation

The common method is the co-culture method, that is, the mononuclear cells are isolated from the peripheral blood of normal people, stimulated and cultured with PHA, and then added to the diagnosis of patients' mononuclear cells and the study of AIDS.

On the one hand, microbial testing is advancing rapidly on the road of integration and intelligence. Major manufacturers have launched a series of overall solutions for various projects of microbial testing through process optimization and information integration; on the other hand, bedside diagnostic products are fast and simple The advantages of high efficiency, low cost, short inspection cycle, and low sample consumption have also attracted more and more clinical attention.