- Email: [email protected]
Development of neonatal screening in Turkey
ABSTRACTS / Clinical Biochemistry 42 (2009) 338–341
the biochemistry tests, which were performed using Olympus AU2700 autoanalyser, was 242,557. The efficiency ratio was 96.8%. The number of tests used for control and calibration processes were 5813 and 1792, respectively. It is observed that in order to have an increase in the kit efficiency, the distillated water system should be controlled well, control and calibration materials should be prepared carefully and the expiration dates of the reagent kits should be checked properly. Conclusions: The efficiency ratios are calculated to be higher than the ratio suggested by the Ministry of Health of Turkey. Keyword: Laboratory performance doi:10.1016/j.clinbiochem.2008.09.087
D4 Development of neonatal screening in Turkey Mehriban Ulas Department of Biochemistry Laboratory, Goztepe Training and Research Hospital, Istanbul, Turkey Objectives: Genetically inherited diseases are the most vital social health problems in Turkey where approximately 1.5 million babies are born every year. Mental retardation and newborn deaths caused by metabolic diseases can be avoided by screening the blood samples of newborns applied onto a special paper (S and S/903). A system that includes education, screening, diagnosis, follow up, management and evaluation stages in regards to these diseases will help ease the solution. In order to tell whether the screening was performed properly in quality control perspective: patient babies should be quickly detected, have no negative results, should minimize the inaccurate positive results and the treatment needs to begin before the negative effects take place. Design and Methods: In my research; the samples that were taken from 43,653 babies born in the hospitals located at various parts of Istanbul, were screened against the phenylketonuria disease and 19 of those who had positive results were personally directed to the relevant parties for treatment and follow up, after completing the required verification tests. Conclusions: As a result; neonatal screening test method, assessment of quality control programs, development of the standards, country wide mapping of screened genetic diseases and adding the second screening program are the main aspects that will improve the total quality. Keyword: Neonatal screening doi:10.1016/j.clinbiochem.2008.09.088
D5 The new method for simultaneous measurement of multiple analytes: Multiplex test system and method performances in systemic autoimmune disease diagnosis Yasemin Baskin, Gokhan Afacan, Selcuk S. Erkunt, Turkan Yigitbasi Regional Hygiene Institute, Ministry of Health, Izmir, Turkey
339
Objective: It is aimed to study laboratory validity and method performances of the new multiple test system (Multiplex) that was developed for autoimmune antibody determination. Design and Methods: The test is a multiplexed, fluorescent, bead-based system using patented xMAP technology. It was designed to perform multiple assays from a single sample, simultaneously. Ten different autoantibodies (SSA, SSB, U snRNP B/ B′, U1 snRNP A, U1 snRNP C, Scl-70, Jo-1, Centromer B, dsDNA, histone and HEp-2 cell nuclear extract) were evaluated in 1136 serum samples by real time multiplex; positive samples were confirmed by IFA method as the gold standard. Results: In 7.75% of samples, antinuclear antibody (ANA) was determined positively and in 2.24% of samples, double stranded (ds) DNA was determined positively. The highest value in between day precisions was 15.68 for HEp2 as shown in the table. Table Performance characteristics of multiplexed test system HEp/ dsDNA SS-A SS-B Sm RNP Scl-70 Jo-1 Cent Histone 2N IU/mL AU/mL AU/mL AU/mL AU/mL AU/mL AU/mL AU/mL AU/mL Day to day precision CV% Between day precision CV% Negative control precision CV% Approved precision CV%
15.68 11.91
7.74
6.65
10.11
9.57
10.26
6.25
8.26
13.41
1.55
3.85
2.81
2.85
2.52
2.32
3.28
3.21
4.21
3.24
7.07
8.84
14.14
10.10
8.32
3.72
5.65
8.84
21.75
10.88
20
20
20
20
20
20
20
20
20
20
Reproducibility was evaluated as outlined in document number EP5-T2: Evaluation of Precision Performance of Clinical Chemistry Devices- Second Edition. National Committee for Clinical Chemistry Laboratory Standards (NCCLS).
Conclusions: We conclude that whether in real time determination of chance and repeatability or in determination of the number of parameters according to the requirements of the laboratory, multiplex method is useful in the routine diagnosis of autoimmune diseases. Keywords: Multiplexed tests; Autoimmunity; Method performance doi:10.1016/j.clinbiochem.2008.09.089
D6 Evaluation of dipstick urinalysis for urinary tract infection Banu Arslan Senturk, Evren Akgol, Demet Arslan Ince, Fusun Ustuner Clinical Biochemistry Laboratory, Ataturk Training Hospital, Izmir, Turkey Objectives: Urinary tract infection (UTI) is one of the most common diseases in primary practice. The diagnosis of UTI is based on urine culture, but a rapid screening test such as urine dipsticks is needed for effective management. The aim of the present study was to evaluate the utility of dipstick urine analysis for UTI.
the biochemistry tests, which were performed using Olympus AU2700 autoanalyser, was 242,557. The efficiency ratio was 96.8%. The number of tests used for control and calibration processes were 5813 and 1792, respectively. It is observed that in order to have an increase in the kit efficiency, the distillated water system should be controlled well, control and calibration materials should be prepared carefully and the expiration dates of the reagent kits should be checked properly. Conclusions: The efficiency ratios are calculated to be higher than the ratio suggested by the Ministry of Health of Turkey. Keyword: Laboratory performance doi:10.1016/j.clinbiochem.2008.09.087
D4 Development of neonatal screening in Turkey Mehriban Ulas Department of Biochemistry Laboratory, Goztepe Training and Research Hospital, Istanbul, Turkey Objectives: Genetically inherited diseases are the most vital social health problems in Turkey where approximately 1.5 million babies are born every year. Mental retardation and newborn deaths caused by metabolic diseases can be avoided by screening the blood samples of newborns applied onto a special paper (S and S/903). A system that includes education, screening, diagnosis, follow up, management and evaluation stages in regards to these diseases will help ease the solution. In order to tell whether the screening was performed properly in quality control perspective: patient babies should be quickly detected, have no negative results, should minimize the inaccurate positive results and the treatment needs to begin before the negative effects take place. Design and Methods: In my research; the samples that were taken from 43,653 babies born in the hospitals located at various parts of Istanbul, were screened against the phenylketonuria disease and 19 of those who had positive results were personally directed to the relevant parties for treatment and follow up, after completing the required verification tests. Conclusions: As a result; neonatal screening test method, assessment of quality control programs, development of the standards, country wide mapping of screened genetic diseases and adding the second screening program are the main aspects that will improve the total quality. Keyword: Neonatal screening doi:10.1016/j.clinbiochem.2008.09.088
D5 The new method for simultaneous measurement of multiple analytes: Multiplex test system and method performances in systemic autoimmune disease diagnosis Yasemin Baskin, Gokhan Afacan, Selcuk S. Erkunt, Turkan Yigitbasi Regional Hygiene Institute, Ministry of Health, Izmir, Turkey
339
Objective: It is aimed to study laboratory validity and method performances of the new multiple test system (Multiplex) that was developed for autoimmune antibody determination. Design and Methods: The test is a multiplexed, fluorescent, bead-based system using patented xMAP technology. It was designed to perform multiple assays from a single sample, simultaneously. Ten different autoantibodies (SSA, SSB, U snRNP B/ B′, U1 snRNP A, U1 snRNP C, Scl-70, Jo-1, Centromer B, dsDNA, histone and HEp-2 cell nuclear extract) were evaluated in 1136 serum samples by real time multiplex; positive samples were confirmed by IFA method as the gold standard. Results: In 7.75% of samples, antinuclear antibody (ANA) was determined positively and in 2.24% of samples, double stranded (ds) DNA was determined positively. The highest value in between day precisions was 15.68 for HEp2 as shown in the table. Table Performance characteristics of multiplexed test system HEp/ dsDNA SS-A SS-B Sm RNP Scl-70 Jo-1 Cent Histone 2N IU/mL AU/mL AU/mL AU/mL AU/mL AU/mL AU/mL AU/mL AU/mL Day to day precision CV% Between day precision CV% Negative control precision CV% Approved precision CV%
15.68 11.91
7.74
6.65
10.11
9.57
10.26
6.25
8.26
13.41
1.55
3.85
2.81
2.85
2.52
2.32
3.28
3.21
4.21
3.24
7.07
8.84
14.14
10.10
8.32
3.72
5.65
8.84
21.75
10.88
20
20
20
20
20
20
20
20
20
20
Reproducibility was evaluated as outlined in document number EP5-T2: Evaluation of Precision Performance of Clinical Chemistry Devices- Second Edition. National Committee for Clinical Chemistry Laboratory Standards (NCCLS).
Conclusions: We conclude that whether in real time determination of chance and repeatability or in determination of the number of parameters according to the requirements of the laboratory, multiplex method is useful in the routine diagnosis of autoimmune diseases. Keywords: Multiplexed tests; Autoimmunity; Method performance doi:10.1016/j.clinbiochem.2008.09.089
D6 Evaluation of dipstick urinalysis for urinary tract infection Banu Arslan Senturk, Evren Akgol, Demet Arslan Ince, Fusun Ustuner Clinical Biochemistry Laboratory, Ataturk Training Hospital, Izmir, Turkey Objectives: Urinary tract infection (UTI) is one of the most common diseases in primary practice. The diagnosis of UTI is based on urine culture, but a rapid screening test such as urine dipsticks is needed for effective management. The aim of the present study was to evaluate the utility of dipstick urine analysis for UTI.