HAEMATOLOGY CONTROL - LEVEL 1, 2, 3 (HAEM CNTL - LEVEL 1, 2, 3)

Transcription

1 HAEMATOLOGY CONTROL - LEVEL 1, 2, 3 (HAEM CNTL - LEVEL 1, 2, 3) CAT NO. HM 5162 LOT NOS. QC , QC , QC SIZE: 3 x 2 x 4.5 ml EXPIRY: GTIN: INTENDED USE This product is intended for in vitro diagnostic use only. SAFETY PRECAUTIONS AND WARNINGS Potentially hazardous biomaterial. Do not ingest. Each donor is tested by FDA approved methods for HbsAg, anti-hcv, HIV-1, HCV (RNA) and HIV-1/2 and found to be negative. Each donor is also found negative by a serological test for Syphilis (RPR or STS). However, it is recommended that the samples are considered to be potentially infectious and should be handled and disposed of in the same manner as patient samples. Health and Safety data sheets are available on request. STORAGE AND STABILITY Samples should always be stored upright at +2 C to +8 C when not in use. Do not allow tubes to overheat or freeze. Opened tubes are stable for 14 days provided they are handled correctly, as described above. PREPARATION 1. Remove the sample tube to be analysed from the refrigerator and allow the sample to warm at room temperature for 15 minutes. 2. Mix the sample by holding the tube horizontally between the palms of the hands. Do not pre-mix on a mechanical mixer. Incomplete mixing of the tube prior to analysis invalidates the sample withdrawn and any remaining material in the tube. a. Roll the tube back and forth for 20 to 30 seconds, occasionally inverting the tube. Mix vigorously but DO NOT SHAKE. b. Continue to mix in this manner until the red cells are completely suspended. c. Gently invert the tube 8 to 10 times immediately before analysing the sample. 3. After sampling: a. Automatic sample handling: Remove the tube from the sample handler immediately after sampling. b. Manual sample handling: Carefully wipe the rim of the tube and cap with a lint-free tissue and replace the cap. 4. Return the tube to the refrigerator within 30 minutes of use. MATERIALS PROVIDED Haematology Control - Level 1 Haematology Control - Level 2 Haematology Control - Level 3 2 x 4.5 ml 2 x 4.5 ml 2 x 4.5 ml MATERIALS REQUIRED BUT NOT PROVIDED Not applicable. VALUE ASSIGNMENT Assigned values are derived from replicate testing. The expected range of the mean is provided to aid each laboratory until it has established its own mean and SD for its methods. Refer to CD included in kit for values. The included CD can be used to upload the control values and ranges to the following Sysmex instruments: XE-5000, XE-2100, XN Series, XT-4000i, XS-1000i, XT-2000i, and XT1800i. Values are also shown below. Instructions for uploading values can be found in the user manual of the relevant instrument. In the case that instructions are not present, please contact applications@randox.com. Values for Platelet-O (PLT-O) may not automatically upload onto XN Series analysers. Therefore, users of the XN Series analysers should manually enter values for PLT-O onto their analysers. Values may be downloaded as an Adobe PDF file from the Randox website: : Type the HM5162 Cat. No. beside the Search Cat or Desc prompt. Select the appropriate lot no. from the View Document list. Haematology controls may not be suitable for control of NRBC# and Basophil on some Sysmex models. These analytes are present at base levels and some instruments will not be able to detect these. 17 Jan 17 bm PAGE 1 OF 12

2 Sysmex XE-5000 (manual sampling) WBC (10 9 /L) 3.80 ± ± ± WBC-D (10 9 /L) 3.75 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.0 ± ± ± MCV (fl) 75.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 33.8 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 57 ± ± ± MPV (fl) 9.4 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± NRBC# (10 9 /L) 0.00 ± ± ± NRBC% (/100 WBC) 0.0 ± ± ± PLT-O (10 9 /L) 68 ± ± ± IPF (%) 21.0 ± ± ± IMI# 800 ± ± ± IG # (10 9 /L) 0.57 ± ± ± IG% 15.0 ± ± ± HPC (10 3 /ul) ± ± ± IMIDC (fl) ± ± ± IMIRF (fl) ± ± ± NRBC-X (ch) ± ± ± NRBC-Y (ch) ± ± ± RBC-O (10 12 /L) 2.41 ± ± ± RBC-X (ch) 19.0 ± ± ± RBC-Y (ch) ± ± ± PAGE 2 OF 12

3 Sysmex XE-5000 (closed sampling) LEVEL 1 LEVEL 2 LEVEL 3 WBC (10 9 /L) 3.80 ± ± ± WBC-D (10 9 /L) 3.75 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.0 ± ± ± MCV (fl) 75.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 33.8 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 57 ± ± ± MPV (fl) 9.4 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± NRBC# (10 9 /L) 0.00 ± ± ± NRBC% (/100 WBC) 0.0 ± ± ± PLT-O (10 9 /L) 68 ± ± ± IPF (%) 21.0 ± ± ± IMI# 800 ± ± ± IG # (10 9 /L) 0.57 ± ± ± IG% 15.0 ± ± ± HPC (10 3 /ul) ± ± ± IMIDC (fl) ± ± ± IMIRF (fl) ± ± ± NRBC-X (ch) ± ± ± NRBC-Y (ch) ± ± ± RBC-O (10 12 /L) 2.41 ± ± ± RBC-X (ch) 19.0 ± ± ± RBC-Y (ch) ± ± ± PAGE 3 OF 12

4 Sysmex XE-2100 (manual sampling) WBC (10 9 /L) 3.80 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.0 ± ± ± MCV (fl) 75.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 33.8 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 57 ± ± ± MPV (fl) 9.4 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± NRBC# (10 9 /L) 3.50 ± ± ± NRBC% (/100 WBC) ± ± ± PLT-O (10 9 /L) 68 ± ± ± IPF (%) 21.0 ± ± ± IMI# 800 ± ± ± IG # (10 9 /L) 0.57 ± ± ± IG% 15.0 ± ± ± HPC (10 3 /ul) ± ± ± IMIDC (fl) ± ± ± IMIRF (fl) ± ± ± NRBC-X (ch) ± ± ± NRBC-Y (ch) ± ± ± RBC-O (10 12 /L) 2.41 ± ± ± RBC-X (ch) 19.0 ± ± ± RBC-Y (ch) ± ± ± PAGE 4 OF 12

5 Sysmex XE-2100 (closed sampling) WBC (10 9 /L) 3.80 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.0 ± ± ± MCV (fl) 75.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 33.8 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 57 ± ± ± MPV (fl) 9.4 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± NRBC# (10 9 /L) 3.50 ± ± ± NRBC% (/100 WBC) ± ± ± PLT-O (10 9 /L) 68 ± ± ± IPF (%) 21.0 ± ± ± IMI# 800 ± ± ± IG # (10 9 /L) 0.57 ± ± ± IG% 15.0 ± ± ± HPC (10 3 /ul) ± ± ± IMIDC (fl) ± ± ± IMIRF (fl) ± ± ± NRBC-X (ch) ± ± ± NRBC-Y (ch) ± ± ± RBC-O (10 12 /L) 2.41 ± ± ± RBC-X (ch) 19.0 ± ± ± RBC-Y (ch) ± ± ± PAGE 5 OF 12

6 Sysmex XT-2000i TM and Sysmex XT-1800i TM (manual sampling) WBC (10 9 /L) 3.80 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.5 ± ± ± MCV (fl) 77.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 32.9 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 64 ± ± ± MPV (fl) 9.0 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± PLT-O (10 9 /L) 60 ± ± ± IG # (10 9 /L) 0.61 ± ± ± IG % 16.0 ± ± ± RBC-O (10 12 /L)* 2.41 ± ± ± RBC-X (ch)* 19.0 ± ± ± RBC-Y (ch)* ± ± ± PAGE 6 OF 12

7 Sysmex XT-2000i and Sysmex XT-1800i (closed sampling) WBC (10 9 /L) 3.80 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.5 ± ± ± MCV (fl) 77.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 32.9 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 64 ± ± ± MPV (fl) 9.0 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± PLT-O (10 9 /L) 60 ± ± ± IG # (10 9 /L) 0.61 ± ± ± IG % 16.0 ± ± ± RBC-O (10 12 /L)* 2.41 ± ± ± RBC-X (ch)* 19.0 ± ± ± RBC-Y (ch)* ± ± ± PAGE 7 OF 12

8 Sysmex XS-1000i WBC-C (10 9 /L) 3.80 ± ± ± WBC-D (10 9 /L) 3.95 ± ± ± RBC (10 12 /L) 2.35 ± ± ± HGB (g/dl) 5.7 ± ± ± HCT (%) 18.3 ± ± ± MCV (fl) 77.9 ± ± ± MCH (pg) 24.3 ± ± ± MCHC (g/dl) 31.1 ± ± ± RDW-SD (fl) 45.5 ± ± ± RDW-CV (%) 17.0 ± ± ± PLT (10 9 /L) 65 ± ± ± MPV (fl) 9.0 ± ± ± NEUT # (10 9 /L) 2.29 ± ± ± LYMPH # (10 9 /L) 0.63 ± ± ± MONO # (10 9 /L) 0.10 ± ± ± EO # (10 9 /L) 0.59 ± ± ± BASO # (10 9 /L) 0.34 ± ± ± NEUT% 58.0 ± ± ± LYMPH% 16.0 ± ± ± MONO% 2.5 ± ± ± EO% 15.0 ± ± ± BASO% 8.5 ± ± ± PCT (%) 0.06 ± ± ± PDW (fl) 12.0 ± ± ± P-LCR (%) 17.0 ± ± ± DIFF-X (ch) ± ± ± DIFF-Y (ch) 55.0 ± ± ± FSC-X 29.5 ± ± ± PAGE 8 OF 12

9 Sysmex XT-4000i TM (manual sampling) LEVEL 1 LEVEL 2 LEVEL 3 WBC (10 9 /L) 3.80 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.5 ± ± ± MCV (fl) 77.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 32.9 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 64 ± ± ± MPV (fl) 9.0 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± PLT-O (10 9 /L) 60 ± ± ± IG # (10 9 /L) 0.61 ± ± ± IG % 16.0 ± ± ± RBC-O (10 12 /L) 2.41 ± ± ± RBC-X (ch) 19.0 ± ± ± RBC-Y (ch) ± ± ± PAGE 9 OF 12

10 Sysmex XT-4000i (closed sampling) WBC (10 9 /L) 3.80 ± ± ± RBC (10 12 /L) 2.39 ± ± ± HGB (g/dl) 6.1 ± ± ± HCT (%) 18.5 ± ± ± MCV (fl) 77.5 ± ± ± MCH (pg) 25.5 ± ± ± MCHC (g/dl) 32.9 ± ± ± RDW-SD (fl) 44.5 ± ± ± RDW-CV (%) 16.5 ± ± ± PLT (10 9 /L) 64 ± ± ± MPV (fl) 9.0 ± ± ± NEUT # (10 9 /L) 2.43 ± ± ± LYMPH # (10 9 /L) 0.67 ± ± ± MONO # (10 9 /L) 0.15 ± ± ± EO # (10 9 /L) 0.55 ± ± ± BASO # (10 9 /L) 3.04 ± ± ± PLT-O (10 9 /L) 60 ± ± ± IG # (10 9 /L) 0.61 ± ± ± IG % 16.0 ± ± ± RBC-O (10 12 /L) 2.41 ± ± ± RBC-X (ch) 19.0 ± ± ± RBC-Y (ch) ± ± ± PAGE 10 OF 12

11 Sysmex XN Series WBC (10 9 /L) 3.70 ± ± ± WBC-D (10 9 /L) 3.60 ± ± ± RBC (10 12 /L) 2.29 ± ± ± HGB (g/dl) 5.9 ± ± ± HCT (%) 17.5 ± ± ± MCV (fl) 76.5 ± ± ± MCH (pg) 25.8 ± ± ± MCHC (g/dl) 33.7 ± ± ± RDW-SD (fl) 46.0 ± ± ± RDW-CV (%) 17.0 ± ± ± PLT (10 9 /L) 55 ± ± ± MPV (fl) 10.5 ± ± ± NEUT # (10 9 /L) 2.28 ± ± ± LYMPH # (10 9 /L) 0.56 ± ± ± MONO # (10 9 /L) 0.09 ± ± ± EO # (10 9 /L) 0.59 ± ± ± BASO # (10 9 /L) 0.18 ± ± ± NEUT% 61.5 ± ± ± LYMPH% 15.2 ± ± ± MONO% 2.5 ± ± ± EO% 16.0 ± ± ± BASO% 4.8 ± ± ± NRBC# (10 9 /L) 0.40 ± ± ± NRBC% (/100 WBC) 2.0 ± ± ± PLT-O (10 9 /L) 71 ± ± ± PCT (%) 0.06 ± ± ± PDW (fl) 11.0 ± ± ± P-LCR (%) 30.0 ± ± ± IPF (%) 21.0 ± ± ± IG # (10 9 /L) 0.57 ± ± ± IG% 15.4 ± ± ± RBC-O (10 12 /L) 2.26 ± ± ± PAGE 11 OF 12

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