Evaluation of 2015-2016 MOTAKK HBV DNA and HCV RNA External Quality Assessment National Program Results

被引：0

作者：

Karatayli, Ersin ^{[1
]}

Soydemir, Ege ^{[2
]}

Aksoy, Zeynep Busra ^{[2
]}

Kizilpinar, Mehtap ^{[1
]}

Altay Kocak, Aylin ^{[1
,3
]}

Karatayli, Senem Ceren ^{[1
]}

Yurdcu, Esra ^{[1
]}

Yildirim, Umut ^{[4
]}

Guriz, Haluk ^{[5
]}

Bozdayi, Gulendam ^{[6
]}

Yurdaydin, Cihan ^{[7
]}

Ilhan, Osman ^{[8
]}

Yildirim, Yasin ^{[9
]}

Bozdayi, A. Mithat ^{[1
]}

Oguz, Acelya Yalcintas ^{[10
]}

Baris, Ahmet ^{[11
]}

Alp, Alpaslan ^{[12
]}

Aksozek, Alper ^{[13
]}

Sayiner, Arzu ^{[14
]}

Karagul, Aydan ^{[15
]}

Ordu, Aylin ^{[16
]}

Istanbullu, Aye ^{[17
]}

Otlu, Baris ^{[18
]}

Aridogan, Buket ^{[19
]}

Aksu, Burak ^{[20
]}

Buruk, C. Kurtulus ^{[21
]}

Karahan, Ceren ^{[22
]}

Guney, Cakir ^{[23
]}

Toksoz, Devrim ^{[24
]}

Yildirim, Dilara ^{[25
]}

Colak, Dilek ^{[26
]}

Daglar, Duygu Eren ^{[27
]}

Findik, Duygu ^{[28
]}

Kas, Elif ^{[29
]}

Caliskan, Emel ^{[30
]}

Zeyrek, Fadile Yildiz ^{[31
]}

Arslan, Fatma ^{[32
]}

Demir, Feyza ^{[33
]}

Milletli, Fikriye ^{[34
]}

Kibar, Filiz ^{[35
]}

Ozdincer, Furkan ^{[36
]}

Dundar, Gulnur ^{[37
]}

Arslan, Hande ^{[38
]}

Agca, Harun ^{[39
]}

Aliskan, Hikmet Eda ^{[40
]}

Guducuoglu, Huseyin ^{[41
]}

Fidan, Isil ^{[42
]}

Akyar, Isin ^{[43
]}

Afsar, Ilhan ^{[44
]}

Kaleli, Ilknur ^{[45
]}

机构：

[1] Ankara Univ, Hepatol Inst, Ankara, Turkey

[2] Ankara Univ, Biotechnol Inst, Ankara, Turkey

[3] Baskent Univ, Dept Med Microbiol, Fac Med, Ankara, Turkey

[4] Tomurcuk Technol, Cyberpk, Ankara, Turkey

[5] Ankara Univ, Fac Med, Cebeci Cent Lab, Ankara, Turkey

[6] Gazi Univ, Dept Med Microbiol, Fac Med, Ankara, Turkey

[7] Ankara Univ, Div Gastroenterol, Fac Med, Ankara, Turkey

[8] Ankara Univ, Div Hematol, Fac Med, Ankara, Turkey

[9] Ankara Univ, Therapeut Apheresis Ctr, Div Hematol, Fac Med, Ankara, Turkey

[10] Iontek Lab, Istanbul, Turkey

[11] RTA Lab, Kocaeli, Turkey

[12] Hacettepe Univ, Hastaneleri Merkez Lab, Ankara, Turkey

[13] Mugla Sitki Kocman Univ EAH, Mikrobiyoloji Lab, Mugla, Turkey

[14] Dokuz Eylul Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Izmir, Turkey

[15] Antalya Egitim & Arastirma Hastanesi, Antalya, Turkey

[16] Sisli Florence Nightingale Hastanesi, Mol Mikrobiyoloji Lab, Istanbul, Turkey

[17] Medipol Hastanesi, Istanbul, Turkey

[18] Malatya Univ, Tibbi Mikrobiyoloji AD, Malatya, Turkey

[19] Suleyman Demirel Univ, Tibbi Mikrobiyoloji AD, Isparta, Turkey

[20] Marmara Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Istanbul, Turkey

[21] KATU, Tip Fak, Tibbi Mikrobiyoloji AD, Trabzon, Turkey

[22] Ankara Univ, Tip Fak, Ibn I Sina Hastanesi Merkez Mikrobiyoloji Lab, Ankara, Turkey

[23] Ozel SYNLAB Merkezi Lab, Ankara, Turkey

[24] Referans Klin Lab, Istanbul, Turkey

[25] Sivas Numune Hastanesi, Mikrobiyoloji Lab, Sivas, Turkey

[26] Akdeniz Univ Hastanesi, Merkez Lab, Antalya, Turkey

[27] Aydin Devlet Hastanesi, Tibbi Mikrobiyoloji Lab, Aydin, Turkey

[28] Selcuk Univ, Tibbi Mikrobiyoloji Lab, Tip Fak, Konya, Turkey

[29] Ankara 2 Bolge KHB Genel Sekreterligi, Ankara, Turkey

[30] Duzce Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Duzce, Turkey

[31] Harran Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Sanliurfa, Turkey

[32] Kayseri Egitim & Arastirma Hastanesi, Kayseri, Turkey

[33] SB SBU Van EAH Mikrobiyoloji Bolumu, Van, Turkey

[34] Ahi Evran Univ, EAH Mikrobiyoloji Lab, Kirsehir, Turkey

[35] Cukurova Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Adana, Turkey

[36] Gelisim Tip Lab, Istanbul, Turkey

[37] Ctr Lab Mol Mikrobiyoloji, Istanbul, Turkey

[38] Baskent Univ, Enfeksiyon Hastaliklari & Klin Mikrobiyoloji AD, Ankara, Turkey

[39] Uludag Univ, Tip Fak, Mikrobiyoloji AD, Bursa, Turkey

[40] Baskent Univ, Tibbi Mikrobiyoloji AD, Adana Uygulama & Arastirma Merkezi Mikrobiyoloji, Adana, Turkey

[41] Yuzuncu Yil Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Van, Turkey

[42] Gazi Univ, Tip Fak, Tibbs Mikrobiyoloji AD, Ankara, Turkey

[43] Acibadem Labmed Mikrobiyoloji Lab, Istanbul, Turkey

[44] IKCU Ataturk EAH Tibbi Mikrobiyoloji Lab, Izmir, Turkey

[45] Pamukkale Univ, Tibbi Mikrobiyoloji Merkez Lab, Denizli, Turkey

[46] Usak Devlet Hastanesi Mikrobiyoloji Lab, Usak, Turkey

[47] Ondokuz Mayis Univ, Tip Fak, Tibbi Mikrobiyoloji AD, Samsun, Turkey

[48] Istanbul Univ, Cerrahpa Tip Fak, Tibbi Mikrobiyoloji AD, Istanbul, Turkey

[49] Trabzon Kanuni EAH Klin Mikrobiyoloji Lab, Trabzon, Turkey

[50] Necmettin Erbakan Univ Hastanesi, Tibbi Mikrobiyoloji AD, Konya, Turkey

来源：

MIKROBIYOLOJI BULTENI | 2018年 / 52卷 / 04期

关键词：

HBV DNA; HCV RNA; external quality control; viral load; REAL-TIME PCR; HEPATITIS-B; CLINICAL MICROBIOLOGY; PROFICIENCY; TESTS;

D O I：

10.5578/mb.67081

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

MOTAKK, as a national external quality control program has been launched to evaluate the molecular detection of viral infections including HBV DNA and HCV RNA in molecular microbiology diagnostic laboratories in Turkey. This program is prepared in compliance with ISO 17043:2010 (Conformity assessment general requirements for proficiency testing) standards, and aims to take the place of external quality control programs from abroad, contributing to standardization and accuracy of molecular diagnostic tests in our country. The aim of this study was to evaluate 2015 and 2016 results of the MOTAKK External Quality Control Program for HBV DNA and HCV RNA viral load. The calls were announced on the web page of MOTAKK (www.motakk.org). The quality control samples were sent to participating laboratories in 2015 and 2016. Main stocks were prepared from patients with chronic hepatitis B and C who had viral load detection with reference methods according to WHO reference materials for viral load studies to improve quality control sera. From these main stocks, samples with different viral loads were prepared from dilutions of plasma with HBV, HCV, HAV, HIV, Parvovirus B19 and CMV negative serologic markers. Quality control samples were sent to the participating laboratories along with the negative samples in the cold chain. The laboratories accomplished the related tests within 2-3 weeks and entered their results on the MOTAKK web page. These results were analysed according to ISO 13528 (Statistical methods for use in proficiency testing by interlaboratory comparison) and scoring reports were created by a software developed by MOTAKK and sent to participating labs. Each laboratory evaluated their own results in comparison with the other laboratory results, reassessed the tests via observing the distance from the mean result and the reference values. The number of laboratories participating in the HBV DNA and HCV RNA external quality control program was 70-73 in 2015-2016. Participants were able to comply with the program tools, registering, entering results and receiving the results reports problem. In HBV panel, 72.6-89.1% and 84.7-90.3% of the participant laboratories were in 1 standard deviation (SD) in 2015-2016, respectively. In HCV panel, 70.8-89.1% and 84.7-90.3% of the participant laboratories were in 1 SD in 2015-2016, respectively. A national external quality control program for HBV DNA and HCV RNA in Turkey has been prepared for the first time with this project and implemented successfully. All the data provided in the MOTAKK external quality control program final report, compensate all the data provided by the quality control program final reports from abroad; additionally, the report allows comparison of used technologies and commercial products.

引用

页码：348 / 366

页数：19

共 29 条

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