CARIBBEAN REGION EXTERNAL QUALITY ASSESSMENT SCHEME. Evaluation Booklet. Performance Evaluation Panel OPS0106 C. Coordination:

Transcription

1 EXTERNAL QUALITY ASSESSMENT SCHEME Evaluation Booklet CARIBBEAN REGION Performance Evaluation Panel OPS0106 C Coordination: Fundação Pró-Sangue Hemocentro de São Paulo Pan American Health Organization International Consortium for Blood Safety Caribbean Epidemiology Centre São Paulo, 16 October 2006

2 Table of Contents Participant Laboratories Panel OPS0105 C target result Panel OPS0105 characterization tests result Syphilis Ant - HIV Ant - HTLV-I/II Ant - HCV HBsAg Confirmatory test Analysis of testing result by Parameter Participants Survey Sample Test kits GLOSSARY CO = Cut off OD = Optical Density IFI = Indirect Immunofluorescence FNR = False Negative Result FPR = False Positive Result TND = Total of Determinations in Negative Samples TPD = Total of Determinations in Positive Samples 2

3 COUNTRY PARTICIPANTS Anguilla Princess Alexandra Hospital Antigua Holberton Hospital, Pathology Laboratory Aruba Stichting Blood Bank Bahamas Rand Memorial Hospital Bahamas Princess Margaret Hospital Belize Central Medical Laboratory Cayman Islands Cayman Islands Health Services, George Town Hospital Dominica Medical Laboratory, Princess Margaret Hospital Grenada Pathology Laboratory, General Hospital Guyana National Blood Transfusion Service, Public Hospital Haiti Centre National de Transfusion Sanguinea Saint Lucia Ezra Long Laboratory, Victoria Hospital St. Kitts Joseph N. France General Hospital St. Vincent and The Grenadines Pathology Laboratory, Milton Cato Memorial Hospital Suriname National Blood Bank Suriname Red Cross Society Trinidad National Blood Transfusion Center One performance evaluation panel (OPS0106C) containing 6 samples with positivity to ant-hiv, anti-hcv, ant-htlv, Syphilis and HBsAg were shipped to each participant. The survey samples were undiluted, defibrinated plasma obtained from individual donors and containing 0.05% of Bronidox L 5 as a preservative. Of the 21 participants that were sent the performance evaluation panel, 5 of them (24%) did not return the results. 3

4 Panel OPS 0106 C Target Result Sample Syphilis HIV HTLV HCV HBsAg 1 X X 2 X 3 X 4 X 5 X 6 X X Characterization tests result of the Performance Evaluation Panel OPS0106 C Tables 1 to 8 show the characterization tests results performed at Fundação Pró- Sangue Hemocentro de São Paulo Quality Control Department. Optical density and cut-off values of the assays are presented for the 6 samples that comprise the Performance Evaluation Panel OPS0106 C. Table 1 Syphilis Bioelisa Syphilis Enzygnost Syphilis RPR BRÁS VDRL Test TPHA L C DO CO DO/CO DO CO DO/CO Result Result Result /128 1/32 Positive NEG NEG NEG NEG NEG NEG NEG NEG NEG NEG NEG NEG /4 1/2 Positive 4

5 Table 2 Ant - HIV Ortho HIV-1/HIV-2 Vironostika HIV HIV Combinado Ag/Ab Ab-Capture Uni-Form II Ag/Ab HVK187 H A55BE DO CO DO/CO DO CO DO/CO DO CO DO/CO 1 3,000 0,129 23, , Ant - HTLV Table 3 Ortho HTLV-I/HTLV-II Ab-Capture Murex HTLV I+II Vironostika HTLV-I/II HTV166 H E85MB DO CO DO/CO DO CO DO/CO DO CO DO/CO Table 4 Ant - HCV Murex anti-hcv (version 4.0) Ortho HCV version 3.0 ELISA HCV Ultra M EXE078 BJ02199 DO CO DO/CO DO CO DO/CO DO CO DO/CO

6 Table 5 HBsAg Hepanostika HBsAg Murex HBsAg Enzygnost HBsAg 5.0 Uni-Form II version 3 B95LL H DO CO DO/CO DO CO DO/CO DO CO DO/CO Confirmatory Tests Table 6 HIV 1+2 Western Blot HIV Genelabs lot: AE4037 p17 p24 p31 p39 gp41 p51 p55 p66 gp120 gp160 HIVII Result Positive Table 7 HTLV I/II Western Blot HTLV Genelabs Lot: AK4011 GD21 P19 P24 P26 P28 P32 P36 GP46 P53 RGP46II RGP46I Result Positive Positive Table 8 Hepatitis C CHIRON RIBA HCV 3.0 SIA Lot: VA2190 C100 (P) C33C C22 (P) NS5 hsod Result Positive 6

7 OVERALL RESULTS Graph 1 shows the number of the tests performed by the 16 participants to each parameter. All 16 respondents performed an HIV and Syphilis assay, 15 respondents performed an HBsAg assay, 13 respondents performed HCV and 11 HTLV assay. The table 9 shows the false positive and false negative results reported for each parameter. The total of the false negative results reported was 2.6 % in 189 determinations performed in positive samples and 4.5 % of false positive result in 404 determinations performed in negative samples. Results reported for each parameter nº laboratories Graph 1 HIV HBsAg HCV HTLV Sifilis Parameter Table 9 Percentage of False Negative and False Positive Results by Parameter False Positive % False Negative % Syphilis TND = 79 TPD = 50 Ant-HIV TND = 105 TPD = 28 Ant-HTLV TND = 61 TPD = 39 Ant-HCV TND = 80 TPD = 22 HBsAg TND = 79 TPD = 50 Total TND = 404 TPD = 189 TND = Total of determinations in negative samples TPD = Total of determinations in positive samples 7

8 Performance result of the participants The performance qualification A was attributed to 9 participants to all tests reported. 3 participants had good performance, but reported a few false positive results. Qualification B1 and or B2 to one or two parameter was attributed to them. Qualification C was attributed to 4 participants. Each participant reported false negative result to different parameter: anti HIV (sample 1), HBsAg (sample 1 and 6), Syphilis (sample 6), and anti-htlv (sample 5). Table 10 Participants performance by Parameter ant-hiv HBsAg Syphilis ant-hcv ant-htlv TT10 A A A A A HÁ 01 A A A A A SU 03 A A A A A GR 01 A A A A A AG 01 A A A A - SL 01 A A A A A AT 01 A A A A - BL01 A A A - - SK 01 A - A - - BH 02 A B 2 A A A BH 01 A B 2 A A A DM 01 A A A - B 2 SU 01 A A A A C CA 01 A A C A A GU 02 C A A A - AR 02 B 2 C A A A A = 100% of concordance B 1 = 5% of the total of determinations B 2 = > 5% of the total of determinations C = False negative result -- = Not performed 8

9 Analysis by Sample False Positive and False Negative results (%) reported by sample % Graph Sample % F.P. % F.N. Sample 1 (ant-hiv and Syphilis positive) 7 (13.7 %) false positive result were reported (51 determinations) 3 for HBsAg, 2 for ant-htlv and 2 for ant-hcv 1 (1.8 %) false negative result was reported for ant-hiv(54 determinations) Sample 2 (ant-htlv positive) 1 (1.3 %) false positive result was reported (77 determinations) Sample 3 (ant-hcv positive) 4 (5.3 %) false positive result were reported (75 determinations) 2 for HTLV and 2 for HBsAg Sample 4 (HBsAg + ant-hbc positive) 4 (5.5 %) false positive result were reported (73 determinations) 2 for anti-hcv and 2 for HTLV 1 (4,0 %) false negative result was reported (25 determinations) Sample 5 (ant-htlv positive) 1 (5.3 %) false negative result was reported (19 determinations) Sample 6 (HBsAg + ant-hbc and Syphilis positive) 2 (3.8 %) false positive were reported for ant-hcv (52 determinations) 1 (2.0 %) false negative was reported for HBsAg (49 determinations) 1 (2.0 %) false negative was reported for Syphilis (49 determinations) 9

10 Analysis by KIT Tables 11 to 15 show the number of the false positive and false negative results reported for each kit used by the participants. Table 11 Syphilis KITS FPR % TND FNR % TPD ATI Syphilis RPR Fisher Vue Health Care Trepanostika TP recombinante VDRL Cardiolipin antigen - Dade Behring Stanbio RPR Quich Test Determine Rapid Syphilis TP Assay VDRL Antigen Test for Syphilis Screening ICE Syphilis ID Syphilis antibody test Macrovue RPR Card Serodia TP-PA Syphilis RPR Test - Human TPHA Test Kit - Pharmatec TOTAL Table 12 Ant - HIV KITS FPR % TND FNR % TPD Murex HIV-1.2.O Axsym HIV-I/HIV Vironostika HIV Uni-Form II Ag/Ab Genscreen HIV 1/ IMX HIV-1/HIV-2 III Plus ACCESS HIV 1/ AKUCHEK 1 & 2 Rapid Assay Determine Rapid HIV 1/ Vironostika HIV Uni-Form II Plus O TOTAL Table 13 Ant - HTLV KITS FPR % TND FNR % TPD Murex HTLV I+II Platelia HTLV-I New Vironostika HTLV-I/II TOTAL

11 Table 14 Ant - HCV KITS FPR % TND FNR % TPD Murex anti-hcv (versión 4.0) Axsym HCV v Hepanostika HCV Ultra IMX HCV ACCESS HCV Ab Plus VITROS ECI para anti-hcv TOTAL Table 15 HBsAg KITS FPR % TND FNR % TPD Murex HBsAg versión Axsym HBsAg (v2) AKUCHEK HBsAg Monolisa AgHBs Plus Hepanostika HBsAg Uni-Form II IMX HBsAg (v.2) VITROS ECI para HBsAg ACCESS HBsAg TOTAL Responsible Dra. Márcia Otani Departamento de Controle de Qualidade -Sorologia Fundação Pró-Sangue Hemocentro de São Paulo. Av. Dr. Enéas de Carvalho Aguiar 155 Cerqueira Cezar São Paulo. CEP: Tel: ext. 353 Fax: otanimarcia@prosangue.sp.gov.br o otanimarcia@uol.com.br 11