Evaluation of new MiniCollect Z Serum (Separator) Tubes

Transcription

1 Evaluation of new MiniCollect Z Serum (Separator) Tubes Background: Greiner Bio-One has developed a newly designed MiniCollect tube offering an integrated collection scoop. The advantage of the new tube is that capillaries and funnels are not needed to facilitate blood transfer from the puncture site into the MiniCollect tube. The MiniCollect Z Serum Separator capillary blood collection tube is also featured with a comolded cap which can easily be removed during the collection and sampling process. The interior of the tube is coated with spray-dried blood clotting activator (SiO ). The blood clotting activator speeds up the clotting process. MiniCollect Clot Activator Separator tubes contain an inert, acrylic gel barrier in the bottom of the tube. The specific gravity of the gel lies between the cells and serum. This separation allows serum to be aspirated directly from the MiniCollect tube eliminating the need to transfer serum into another vessel. MiniCollect Z Serum (Separator) Tubes are used to collect, transport, separate and process capillary blood for testing serum in the clinical laboratory. Study Objective: A clinical evaluation was carried out to compare the performance of the MiniCollect Z Serum Separator tube with new design in comparison to old design of MiniCollect Z Serum Separator tube including healthy and pathological subjects. Study design: The following tube types were used in this study: Sample ID A B Description MiniCollect Z Serum Sep.. ml (item No.: ), old design MiniCollect Z Serum Sep..-. ml (item No.: ), new design The study has been approved by Ethics Commission. Informed consent has been given by all participants. Directly after blood collection with venous blood, the tubes were carefully inverted times according to the instructions for use for MiniCollect blood collection tubes. After blood collection, the tubes were allowed to sit for min in an upright position. The listed analytes were tested using an AU and DxI from Beckman Coulter. Analysis was performed with the instrument s accompanying reagents. page /

2 Determined parameters: Albumin Lactate Dehydrogenase (LDH) Aspartate Transaminase (AST) Alanine-Transaminase (ALT) Gamma-glutamyl Transferase (GGT) Alkaline Phosphatase (ALP) Uric Acid Total Bilirubin Cholesterol Triglyceride Sodium Potassium Chloride Calcium Phosphate Magnesium Iron Urea Estradiol Creatine Kinase Total Protein free Triiodothyronine (ft ) free Thyroxine (ft ) Thyroid-Stimulating Hormone (TSH) Cortisol Glucose Progesterone Ferritin Conclusion: Performance of the new MiniCollect Z Serum Separator tube has been demonstrated in comparison to the old MiniCollect Z Serum Separator tube on the basis of the analytes tested. For three samples (B, A, B) from pathological subjects, the sample amount was not sufficient in order to determine all parameters. Several visually hemolytic samples have been detected: A, B / A, B / A, B / A, B / A, B / A, B / A, B. Due to very low absolute values, rather higher analytical deviations have been found for Estradiol and, Progesterone by including male and female subjects. Deviations as found for total bilirubin might be due to the light sensitivity. All systematic deviations that occurred in the measurement of potassium, AST, CK, total bilirubin and phosphate are considered to be without clinical significance. As the new design of MiniCollect Z Serum Separator tubes reduces the likelihood of nonvisible hemolysis, slightly systematically lower values have been found for LDH and potassium. In summary, despite the deviations and results that have been found, none are clinically significant. The MiniCollect Z Serum Separator with the new design is substantially equivalent to the MiniCollect Z Serum Separator with the old design. page /

3 References: () Greiner Bio-One. MiniCollect Z Serum Tubes. Instructions for Use. Kremsmünster, Austria.. () Greiner Bio-One. MiniCollect Product Manual. Kremsmünster, Austria.. () Guideline published by the Chamber Association for Medical Practitioners of the State of Germany concerning the quality assurance of quantitative analyses of Medical Laboratories, Germany (). Rev. () ISO :(E), Single-use containers for venous blood specimen collection. International Standard. () EP-A: Interference Testing in Clinical Chemistry; Approved Guideline Second Edition, CLSI. () EP-A-IR: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline Second Edition (Interim Revision). CLSI. () H-A: Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard Sixth Edition CLSI () H-A: Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens Approved Standard Sixth Edition CLSO () RILIBÄK: Guideline of the German Medical Association for Quality Assurance Results: Results in detail: Albumin Normal range: - g/l ALB g/l Ah ALB g/l Bh ALB [g/l] Ah ALB [g/l] Bh g/l g/l Correlation: r =, Correlation: r =, ALB g/l Bh ALB [g/l] Bh ALB g/l Ah, Conf.Int. ALB [g/l] Ah, Conf.Int. page /

4 Creatine Kinase Normal range: (f) (m) CK A h CK B h CK [] Ah CK [] Bh Correlation: r =, Correlation: r =, CK Bh CK [] Bh CK Ah, Conf.Int. CK [] Ah, Conf.Int. Lactate Dehydrogenase (LDH) Normal range: (f) < (m) < L DH A h L DH B h LDH [ ] Ah LDH [ ] Bh Correlation: r =, Correlation: r =, LDH Bh LDH [] Bh LDH Ah, Conf.Int. LDH [] Ah, Conf.Int. page /

5 Alanine transaminase (ALT) Normal range: (m) < (f) < ALT Ah ALT Bh ALT [] Ah ALT [] Bh Correlation: r =, Correlation: r =, ALT Bh ALT [] Bh ALT Ah, Conf.Int. ALT [] Ah, Conf.Int. Aspartate transaminase (AST) Normal range: (m) < (f) < AST Ah AST Bh AST [] Ah AST [] Bh Correlation: r =, Correlation: r =, AST Bh AST [] Bh AST Ah, Conf.Int. AST [] Ah, Conf.Int. page /

6 Gamma-glutamyl Transpeptidase (GGT) Normal range: (f) < (m) < GGT Ah GGT Bh GGT [] Ah GGT [] Bh Correlation: r =, Correlation: r =, GGT Bh GGT [] Bh GGT Ah, Conf.Int. GGT [] Ah, Conf.Int. Alkaline Phosphatase (ALP) Normal range: - ALP Ah ALP Bh ALP [] Ah ALP [] Bh Correlation: r =, Correlation: r =, ALP Bh ALP [] Bh ALP Ah, Conf.Int. ALP [] Ah, Conf.Int. page /

7 Uric Acid (UA) Normal range: (f). -. (m). -. UA Ah UA Bh UA [] Ah UA [] Bh Correlation: r =, Correlation: r =, UA Bh UA [] Bh UA Ah, Conf.Int. UA [] Ah, Conf.Int. Total Bilirubin (TBili) Normal range:. -.,,,,,,, TBIL Ah TBIL Bh, TBIL [] Ah, TBIL [] Bh,,,,,,,,,,,,,,,, TBIL Bh Correlation: r =,,,,,,,,,,,,,,,,,,,,,,,,,,, TBIL Ah, Conf.Int. TBIL [] Bh Correlation: r =,,,,,,,,,,,,,,,,,,,,,,, TBIL [] Ah, Conf.Int. page /

8 Cholesterol (Chol) Normal range: < CHOL Ah CHOL Bh CHOL [] Ah CHOL [] Bh Correlation: r =, Correlation: r =, CHOL Bh CHOL Ah, Conf.Int. CHOL [] Bh CHOL [] Ah, Conf.Int. Triglyceride (TG) Normal range: normal < borderline high < high < very high TG Ah TG Bh TG [] Ah TG [] Bh Correlation: r =, Correlation: r =, TG Bh TG [] Bh TG Ah, Conf.Int. TG [] Ah, Conf.Int. page /

9 Sodium (Na) Normal range: - NA Ah NA Bh NA [] Ah NA [] Bh Correlation: r =, Correlation: r =, NA Bh NA [] Bh NA Ah, Conf.Int. NA [] Ah, Conf.Int. Potassium (K) Normal range: Serum. -. K Ah K Bh K [] Ah K [] Bh K Bh Correlation: r =,,,,,,,,,,,,,,,, K Ah, Conf.Int. K [] Bh Correlation: r =,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, K [] Ah, Conf.Int. page /

10 Chloride (Cl) Normal range: - CL Ah CL Bh CL [] Ah CL [] Bh Correlation: r =, Correlation: r =, CL Bh CL [] Bh CL Ah, Conf.Int. CL [] Ah, Conf.Int. Calcium (Ca) Normal range:. -., CA Ah CA Bh,,,,,,,,,,,,,, CA [] Ah CA [] Bh,,,,,,,,,,,,,, Correlation: r =,, Correlation: r =,,,,,, CA Bh,,, CA [] Bh,,,,,,,,,,,,,,,,,,,,,,,,,,,,, CA Ah, Conf.Int. CA [] Ah, Conf.Int. page /

11 Phosphate (IP) Normal range:. -.,, IP Ah IP Bh, IP [] Ah IP [] Bh,,,,,,,,,,,,,,, Correlation: r =,, Correlation: r =,,,,,, IP Bh,, IP [] Bh,,,,,,,,,,,,,,,,,, IP Ah, Conf.Int.,,,,,,,,,,,, IP [] Ah, Conf.Int. Magnesium (Mg) Normal range: (f). -. (m). -., MG Ah MG Bh, MG [] Ah MG [] Bh,,,,,,,,,,,, Correlation: r =,, Correlation: r =,,,,,, MG Bh,,,,,, MG [] Bh,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, MG Ah, Conf.Int. MG [] Ah, Conf.Int. page /

12 Iron (Fe) Normal range: (f). -. µmol/l (m). -. µmol/l FE umol/l Ah FE umol/l Bh FE [umol/l] Ah FE [umol/l] Bh µmol/l umol/l Correlation: r =, Correlation: r =, FE umol/l Bh FE [umol/l] Bh FE umol/l Ah, Conf.Int. FE [umol/l] Ah, Conf.Int. Urea Normal range: - UREA Ah UREA Bh UREA [] Ah UREA [] Bh Correlation: r =, Correlation: r =, UREA Bh UREA [] Bh UREA Ah, Conf.Int. UREA [] Ah, Conf.Int. page /

13 Total Protein (TP) Normal range: - g/l TP g/l Ah TP g/l Bh TP [g/l] Ah TP [g/l] Bh g/l g/l Correlation: r =, Correlation: r =, TP g/l Bh TP [g/l] Bh TP g/l Ah, Conf.Int. TP [g/l] Ah, Conf.Int. Free Triiodothyronine (ft ) Normal range:. -. pg/ml FT pg/ml Ah FT pg/ml Bh FT [pg/ml] Ah FT [pg/ml] Bh pg/ml pg/ml,, Correlation: r =, Correlation: r =,, FT pg/ml Bh,, FT [pg/ml] Bh,,,,,,,,,,,,,,,,,,,, FT pg/ml Ah, Conf.Int. FT [pg/ml] Ah, Conf.Int. page /

14 Free Thyroxine (ft ) Normal range:. -. ng/dl ng/dl, FRT ng/dl Ah FRT ng/dl Bh,,,,,, ng/dl,, FRT [ng/dl] Ah FRT [ng/dl] Bh,,,,,,,,,,,,,,, Correlation: r =,, Correlation: r =,,,, FRT ng/dl Bh,,, FRT [ng/dl] Bh,,,,,,,,,,,,,,,,,,,, FRT ng/dl Ah, Conf.Int.,,,,,,,,,,,,,,,, FRT [ng/dl] Ah, Conf.Int. Thyroid-stimulating Hormone (TSH) Normal range:. -. μiu/ml,,, ftsh uiu/ml Ah ftsh uiu/ml Bh TSH [µlu/m l] Ah TSH [µlu/m l] Bh, µlu/ml, uiu/ml,,, ftsh uiu/ml Bh Correlation: r =,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, TSH [uiu/ml] Bh Correlation: r =, - - ftsh uiu/ml Ah, Conf.Int. TSH [uiu/ml] Ah, Conf.Int. page /

15 Cortisol Normal range: morning. -. µg/dl afternoon > µg/dl µg/dl Cortisol ug/dl Ah Cortisol ug/dl Bh ug/dl Cortisol [ug/dl] Ah Cortisol [ug/dl] Bh Correlation: r =, Correlation: r =, Cortisol ug/dl Bh Cortisol [ug/dl] Bh Cortisol ug/dl Ah, Conf.Int. Cortisol [ug/dl] Ah, Conf.Int. Estradiol Normal range: (m) - pg/ml (f) - pg/ml pg/ml OESTRADIOL pg/ml Ah OESTRADIOL pg/ml Bh pg/ml OESTRADIOL [pg/ml] Ah OESTRADIOL [pg/ml] Bh OESTRADIOL pg/ml Bh Correlation: r =, - - OESTRADIOL [pg/ml] Bh Correlation: r =, - - OESTRADIOL pg/ml Ah, Conf.Int. OESTRADIOL [pg/ml] Ah, Conf.Int. page /

16 Progesterone Normal range: (f). -. ng/ml(m) age dependent Prog ng/ml Ah Prog ng/ml Bh Prog [ng/ml] Ah Prog [ng/ml] Bh ng/ml ng/ml Correlation: r =, Correlation: r =, Prog ng/ml Bh Prog [ng/ml] Bh - - Prog ng/ml Ah, Conf.Int. - - Prog [ng/ml] Ah, Conf.Int. Ferritin Normal range: (f). -. µg/l (m). -. µg/l FER_DX ng/ml Ah FER_DX ng/ml Bh FER_AU [ng/ml] Ah FER_AU [ng/ml] Bh µg/l ng/ml Correlation: r =, Correlation: r =, FER_DX ng/ml Bh FER_AU [ng/ml] Bh - - FER_DX ng/ml Ah, Conf.Int. - - FER_AU [ng/ml] Ah, Conf.Int. page /

17 Glucose Normal range: - GLUK Ah GLUK Bh GLUK [] Ah GLUK [] Bh Correlation: r =, Correlation: r =, GLUK Bh GLUK [] Bh GLUK Ah, Conf.Int. GLUK [] Ah, Conf.Int. ENT Rev. page /