The US FDA’s proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing
Sommaire
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Idammn gan yan irz agaman uddir da ittmussun ɣ iẓuṛan d wul, slawan akkʷ s twisi n uɣudir n wul. Irz ad ittyawskar s waman d uflazma, d yan id mlyar n tɣrasin, ɣ umzwaru llant twjjatin zggʷaɣnin nttnti ad as yakkan aklu ann azggʷaɣ i idammn.
Irzi ad ar ittawi awksijin (O2) d isadurn ttɣawsnin ɣ uzzigiz uddir n tuẓḍiḍin akkʷ n tɣssa, zun d urrig n ukarbun (CO2) d warrasn inaẓuṭn, s wansatn n iḍi (tigẓẓal, turin, tasa, adan). Ar daɣ isslkam tiɣrasin d irctuyn n unagraw n uffal s iẓṭwan, isluzzu daɣ iṛmunn s tɣssa kullu tt.
Dar willi mqqurnin, adif n iɣsan ad iṭṭayn tiɣrasin n idammn ɣ yat tzigizt mi ismn "asnulfu n idammn".
Asnay
Lliɣ gan idammn yan uẓṭṭa irzn (igan zun d aman), rad ttyawskarn s kra n ifrdisn iɣrasann ula d kra n izgyan yaḍnin, macc ur gisn llan iẓaggn, ɣayann a f ur iqqur zun d iẓṭawn lummanin. Aswir nns n tsmmi ar ittili gr 7,35 d 7,453. Aklu nns azggʷaɣ ikka d imuglubin (yan ubṛutin illan ɣ ugns n twjjatin zggʷaɣnin).
Ifrdisn n idammn
- Taɣrast tazggʷaɣt n idammn niɣ d tawjja tazggʷaɣt (imisi n 99%). Ur dars illi kra iga tt uɣrmi ula kra n tisayt mayad ɣar ɣ dar id bu tibbit hlli, maccan ɣ dar imudar yaḍnin zun d aylaln llan ukan darsn.
- Ar ittamu wanaw ad n tɣrasin ɣaylli mi ismn imuglubin (1/3 n mad iddaln asituflazm) ɣaylli iṛẓẓmn asaka i usmutti n urrig n uksijin d win ukarbun d wuzzal. Ṭṭafn ula inzimn nna asn ttyawsnin ad ttidirn, smadn tawuri nnsn. Ku d tɣrast ar d ttidir dili n 120 n wass d mggu nns ar ittili ɣ uswir n inṛfaḍ, ittɣʷi daɣ imuglubin s imakṛufajn n tasa d win inṛfaḍ d iɣsan.
Aflazma
Aflazma iga tamtta irzan ɣ ar ttaywuln ifrdisn n idammn. Ittyawskar s waman d iyunatn d ibrzzuyn ttmattaynin ɣ ugns n tɣssa. Iqqan d daɣ ad nsngiri aflazma d usiṛum, acku naḥya tn yan imikk ɣ usnay, d usiṛum ur gis illi ufibrinujin.
Ibrzzuyn nyafnin da fssinin ɣ irz n uflazma (gn waman amssfsi nnsn) gan d:
• Aglikuz
• Inddadn
• Ibṛutiyn (nml ad tn naṭṭu s imiss n iliktrufuriz n mnnaw wafatn: albumin, α1, α2, β, ɣ), wida gisn nyafnin gan tn:
•Albumin igan zun d yan umaway n tɣawsiwin.
•Iminuglubin n ungraw anaffal.
•Imsmadn dar illa udɣar ɣ ussnti n usadmr i ufduddr.
•Ibrutiyn n ikkil n idammn.
Kra ɣ ifrdisn ad gan iṛmunn, ẓḍaṛn nit ad gin ibṛuṭiyn, niɣ d ismamn iminitn ttyawnfalnin, niɣ d istirwidn, niɣ indaddn ttyawnfalnin (zun d afṛuṣṭaglandin d uḍṛumbuksan).