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KET QUA TOI Oil HOA DIEU KIEN SAN XUAT MAU NGOAI KIEM TRA CHAT LlflfNG

XET NGHIEM VI SINH LAM SANG DANG DENH PHAM GIA DjNH MAU, PHAN,

NIT0C TIEU CHUA VI KHUAN GAY DENH THlOTNG GAP HOAC TAP NHliM

TRAN HlTU TAM, VO NGOC NGUYEN, TRUONG QUAN THUY,

n g u y I n TH| THANH TAM, NGUYEN THj HONG PHUONG, PHI XUAN TIEN.

Trung tam Kiem chuan Xet nghiem TP.HCM

TOM TAT

Ngoai kiem tra chat luong xet nghiem (EQAs) da

duxyc Bo Y te ban hanh thanh quy dinh trong quan ly

c h it luong xdt nghiem, ve mdt chuyen mon, day la mot

trong nhung cong cu de ddnh gia do tin cay cua xdt

nghiem, phdt hien sai so [1], [3], De trien khai duoc

hoat dong ngoai kiem tra chat luong xdt nghiem, can

phai cd cdc mdu kiem chuan, dac biet Id trong kiem tra

chat luong vi sinh lam sang, vi nhung ly do khach

quan nhu an toan sinh hoc, thdi gian song cua vi

khuin,...nen cac mdu benh pham gia dinh hau nhu

khong cd cac cdng ty thuong mai cung cap.

Dua tren ket qua khao sat cac mdu benh pham va

vi khuan thuong gap tai cac phdng xdt nghiem vi sinh

Idm sang [4], nhdm nghien cuu da xay dung quy trinh

san x u it m iu benh p him gia dinh mdu, phan, nude

tieu chua vi khuin gay benh thuvng gap va vi khuin

thuvng tm (hodc tap nhidm), tien hanh cac thi nghiem

sang loc va toi uu hda theo ma tran Plackett - Burman,

phuong phdp duong doc nhit, phuong phap ham dap

ung b i mdt - c iu true cd tam (RSM - CCD). Ket qua

da xdc dinh duxyc dieu kien san x u it va tim ra duxyc

cdng thuc toi uu voi cac thanh phan chi tiet cd the dp

dung san x u it ba mau benh p him gia dinh chua vi

khuin gdy benh va vi khuin thuvng tm gom: Mdu mdu

(Staphylococcus epidermidis, Acinetobacter

baumannii, vi khuin tap nhidm Burkholderia cepacia),

mdu phdn (Shigella sonnei, Salmonella paratyphi A, vi

khuin thudng tm Proteus vulgaris), m iu nu&c tiSu

(Proteus vulgaris, Enterococcus faecalis).

TCp khda: Ngoai kiem, phan, mdu, nudfc tieu,

Plackett - Burman. RSM - CCD.

SUMMARY

External quality assessment scheme (EQAs) was

declared in the medical quality management

regulation by Vietnam Ministry of Health, EQAs is one

of the tools for evaluating the reliability of diagnosis

[1], [3], To expanding the EQAs, we need the EQAs

materials, especially in clinical microbiology, there is

almost no commercial materials because of the

objective reasons such as biosafety, lifetime of

bacteria,...

Based on the results of a survey the common

samples and bacteria at the clinical microbiology

laboratories [4], we set up the process for

manufacturing of EQAs samples (blood, faeces,

urine), which contain the malignant and contaminated

bacteria, then we do the screening experiments,

optimize them following the Plackett - Burman matrix,

the steepest descent method, response surface

methodology - central composite design (RSM -

CCD). Finally, we find out the condition for

manufacturing and the ingredient with the best

selecting factors for manufacturing EQAs samples

containing the malignant and contaminated bacteria:

blood (Staphylococcus epidermidis, Acinetobacter

baumannii, contaminated Burkholdena cepacia),

faeces (Shigella sonnei, Salmonella paratyphi A,

contaminated Proteus vulgaris), urine (Proteus

vulgaris, Enterococcus faecalis).

Keywords: EQAs, blood, faeces, urine, Plackett

- Burman, RSM - CCD.

DAT VAN 0£:

De trien khai ngoai kiem tra chat luang xet

nghiem vi sinh lam sang vai muc tieu danh gia n£ng

lye thu-c hien cua phong xet nghiem tren tung benh

canh cu the, can phai co m iu benh pham gia dinh

chua cac vi khuan thuang g3p (gay benh, thuang tru

hoac tap nhiim). Mot trong nhu'ng yeu cau quan

trong do la m iu phai dap ung tieu chi bao quan vi

Y HOC THUC HANH (922) - SO 6/2014 39