Indasteri ea IVD e ka aroloa ka likaroloana tse hlano: tlhahlobo ea biochemical, immunodiagnosis, tlhahlobo ea lisele tsa mali, tlhahlobo ea limolek'hule le POCT.
1. Tlhahlobo ea lik'hemik'hale
1.1 Tlhaloso le lihlopha
Lihlahisoa tsa biochemical li sebelisoa tsamaisong ea ho lemoha e entsoeng ka li-analyzer tsa biochemical, li-reagents tsa biochemical, le li-calibrator. Hangata li behoa laboratoring ea sepetlele le litsing tsa tlhahlobo ea 'mele bakeng sa litlhahlobo tsa ka mehla tsa biochemical.
1.2 Sehlopha sa tsamaiso
2. Immunodiagnosis
2.1 Tlhaloso le lihlopha
Clinical immunodiagnosis e kenyelletsa chemiluminescence, enzyme-linked immunoassay, khauta ea colloidal, immunoturbidimetric le latex lintho tsa biochemistry, li-analyzer tse khethehileng tsa protheine, joalo-joalo.
Sistimi ea analyzer ea chemiluminescence ke motsoako oa boraro-bo-bong ba li-reagents, lisebelisoa le mekhoa ea tlhahlobo. Hajoale, khoebo le indasteri ea li-analyzer tsa chemiluminescence immunoassay 'marakeng li arotsoe ho latela tekanyo ea automation,' me li ka aroloa ka semi-automatic (plate type luminescence enzyme immunoassay) le othomathike ka botlalo (mofuta oa tube luminescence).
2.2 Tšebetso ea pontšo
Chemiluminescence hajoale e sebelisoa haholo ho bona lihlahala, tšebetso ea qoqotho, lihomone le mafu a tšoaetsanoang. Liteko tsena tse tloaelehileng li nka 60% ea kakaretso ea 'maraka le 75% -80% ea tekanyo ea teko.
Hona joale, liteko tsena li nka karolo ea 80% ea karolo ea 'maraka. Bophara ba tšebeliso ea liphutheloana tse itseng bo amana le litšobotsi, tse kang tšebeliso e mpe ea lithethefatsi le tlhahlobo ea lithethefatsi, tse sebelisoang haholo Europe le United States, le tse fokolang haholo.
3. Maraka ea lisele tsa mali
3.1 Tlhaloso
Sehlahisoa sa ho bala lisele tsa mali se na le sehlahlobi sa lisele tsa mali, li-reagents, li-calibrator le lihlahisoa tsa taolo ea boleng. Hematology analyzer e boetse e bitsoa hematology analyzer, blood cell instrument, blood cell counter, joalo-joalo. Ke e 'ngoe ea lisebelisoa tse sebelisoang haholo bakeng sa tlhahlobo ea bongaka ea RMB 100 milione.
Mohlahlobi oa lisele tsa mali o arola lisele tse tšoeu tsa mali, lisele tse khubelu tsa mali le liplatelete tse maling ka mokhoa oa ho hanyetsa motlakase, 'me a ka fumana lintlha tse amanang le mali joalo ka hemoglobin concentration, hematocrit, le karo-karolelano ea karolo ka 'ngoe ea sele.
Lilemong tsa bo-1960, ho baloa ha lisele tsa mali ho ile ha finyelloa ka ho silafatsa le ho bala ka letsoho, e neng e le thata ts'ebetsong, ts'ebetso e fokolang, ho se fumanehe ho nepahetseng, litekanyetso tse fokolang tsa tlhahlobo, le litlhoko tse phahameng tsa lingaka. Mefokolo e fapaneng e thibetse ts'ebeliso ea eona lefapheng la tlhahlobo ea bongaka.
Ka 1958, Kurt o ile a theha k'haonte ea lisele tsa mali e bonolo ho sebetsa ka ho kopanya resistivity le theknoloji ea elektronike.
3.2 Karolelano
3.3 Mokhoa oa ntlafatso
Theknoloji ea lisele tsa mali e tšoana le molao-motheo oa cytometry ea phallo, empa litlhoko tsa ts'ebetso ea cytometry ea phallo li hloekisitsoe haholoanyane, 'me e sebelisoa haholo lilaboratoring e le lisebelisoa tsa lipatlisiso tsa saense. Ho se ho ntse ho e-na le lipetlele tse kholo tse phahameng tse sebelisang cytometry ea phallo litleliniking ho hlahloba likarolo tse entsoeng maling ho hlahloba mafu a mali. Teko ea lisele tsa mali e tla tsoela pele ka tsela e ikemetseng le e kopanetsoeng.
Ho feta moo, lintho tse ling tsa tlhahlobo ea lik'hemik'hale tse kang CRP, hemoglobin ea glycosylated le lintho tse ling, li kopantsoe le tlhahlobo ea lisele tsa mali lilemong tse peli tse fetileng. Phala e le 'ngoe ea mali e ka phethoa. Ha ho na tlhoko ea ho sebelisa serum bakeng sa tlhahlobo ea biochemical. CRP feela ke ntho e le 'ngoe, e lebeletsoeng ho tlisa sebaka sa maraka sa limilione tse likete tse 10.
4.1 Selelekela
Tlhahlobo ea limolek'hule e 'nile ea e-ba sebaka se chesang lilemong tsa morao tjena, empa tšebeliso ea eona ea bongaka e ntse e e-na le mefokolo. Tlhahlobo ea limolek'hule e bolela ts'ebeliso ea mekhoa ea baeloji ea limolek'hule bakeng sa ho lemoha liprotheine tsa sebopeho se amanang le mafu, li-enzyme, li-antigen le li-antibodies, le limolek'hule tse fapaneng tse sebetsang ka matla a ho itšireletsa mafung, hammoho le liphatsa tsa lefutso tse kenyang limolek'hule tsena. Ho ea ka mekhoa e fapaneng ea ho lemoha, e ka aroloa ka hybridization ea lichelete, PCR amplification, gene chip, gene sequencing, mass spectrometry, joalo-joalo. mafu a liphatsa tsa lefutso, tlhahlobo ea bokhachane, ho thaepa ha lisele le likarolo tse ling.
4.2 Karolelano
4.3 Kopo ea Mmaraka
Tlhahlobo ea limolek'hule e sebelisoa haholo mafung a tšoaetsanoang, ho hlahloba mali le masimo a mang. Ka ntlafatso ea maemo a bophelo a batho, ho tla ba le tlhokomeliso e eketsehileng le tlhokahalo ea tlhahlobo ea limolek'hule. Nts'etsopele ea indasteri ea bongaka le bophelo bo botle ha e sa lekanyetsoa ho hlahlojoa le kalafo, empa e fetela ho thibelo Meriana ea thobalano. Ka ho manolla 'mapa oa lefutso la motho, tlhahlobo ea limolek'hule e na le menyetla e mengata ea kalafo ea motho ka mong esita le tšebeliso e kholo. Tlhahlobo ea limolek'hule e tletse menyetla e mengata e fapaneng nakong e tlang, empa re tlameha ho falimehela pululo ea tlhahlobo e hlokolosi le kalafo.
Joaloka theknoloji ea morao-rao, tlhahlobo ea limolek'hule e entse tlatsetso e kholo tlhahlobong ea bongaka. Hona joale, kopo e ka sehloohong ea tlhahlobo ea limolek'hule naheng ea heso ke ho lemoha mafu a tšoaetsanoang, a kang HPV, HBV, HCV, HIV joalo-joalo. Lits'ebetso tsa tlhahlobo ea bakhachane le tsona li se li holile, joalo ka BGI, Berry le Kang, joalo-joalo, ho fumanoa ha DNA ea mahala maling a peripheral ea lesea ho nkile sebaka sa mokhoa oa amniocentesis butle-butle.
5.POCT
5.1 Tlhaloso le lihlopha
POCT e bua ka mokhoa oa ho hlahloba moo batho bao e seng litsebi ba sebelisang lisebelisoa tse nkehang habonolo ho hlahloba ka potlako mehlala ea bakuli le ho fumana liphello tse molemo ho pota-pota mokuli.
Ka lebaka la phapang e kholo ea mekhoa ea liteko tsa sethala, ho na le mekhoa e mengata ea lisebelisoa tsa tlhahlobo tse kopaneng, ho thata ho hlalosa mofuta oa litšupiso, ho thata ho netefatsa sephetho sa litekanyo, 'me indasteri ha e na litekanyetso tse nepahetseng tsa taolo ea boleng,' me e tla lula e le teng. moferefere le ho qhalakana nako e telele. Mabapi le nalane ea nts'etsopele ea seqhenqha sa machaba sa POCT Alere, kopanyo ea M&A ka har'a indasteri ke mohlala o sebetsang hantle oa nts'etsopele.
5.2 Lisebelisoa tsa POCT tse sebelisoang ka tloaelo
1. Lekola meter ea tsoekere ea mali ka potlako
2. Analyzer ea khase ea mali e potlakileng
Nako ea poso: Jan-23-2021