C3 Control User Manual (W Target)

You might also like

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 2

C3 Control

For in vitro diagnostic use only


【Product Name】
C3 Control
【Package】
2ml per vial
【Intended Use】
C3 control is a quality control material for cell counter setup and performance, and data analysis, the parameters of C3 control includes
WBC, RBC, PLT, HGB, MCV and HCT. Based on the different values of parameters, C3 control is defined as three types: C3-L (low
value), C3-M (medium value) and C3-H (high value).
【Storage and Stability】
1. Store at 2-8℃
2. Freezing is strictly prohibited.
3. Unopened tubes are stable for six months from the production date indicated on each vial.
4. Opened tubes are stable for 14 days.
【Procedure】
1. Hold the tube vertically upwards between the palms of your hands and roll for 5-8 minutes and then downwards for 5 minutes.
2. Gently invert the tube 10 times.
3. Repeat step 2 until the pellet / particles on the bottom of the tube is completely suspended (15 minutes might be necessary).
4. Stand on the tube rack for 1 minute. Invert the tube 10 times immediately before sampling.
5. Remove the lid carefully when sampling and test together with routine specimen.
6. Tightly capped and return the tube to the refrigerator (2-8℃) immediately after sampling.
【Attention】
1. The product is a dark red fluid.
2. After sampling, return the tube to the refrigerator immediately, avoiding contamination and evaporation.
3. Ranges for reported values are based on expected variations due to differences in reagents and instruments. Each laboratory should
establish its own acceptable ranges.
【Expected Range】
1. The product is used for internal quality control and external quality assessment of cell counter.
2. Ranges for reported values are based on expected variations due to differences in reagents, sample volume and test principle of
instruments.
3. For greater control sensitivity, each laboratory should establish its own mean and acceptable range and periodically reevaluate the
mean.
【Traceability】
Assigned values are presented as a mean and range. The mean is derived from replicate testing on instruments operated and
maintained according to the manufacturer’s instructions.

Manufacturer: SINNOWA Medical Science &Technology Co., Ltd www.sinnowa.com


Add: NO.7,Baoshan Road, Tangshan Community, Jiangning District, Nanjing, China
PC: 211135 Tel: +86-25-84127928 Fax: +86-25-84127199 E-mail: sj@sinnowa.com
C3-L (low value) Control Value Sheet

Lot :B0220 Specification: 2ml


Expiry Date: 2020-06-05
HB 7021
Item Unit
MEAN RANGE
WBC ×109/L 2.1 1.5-2.6
RBC ×1012/L 2.45 2.25-2.65
HGB g/dl 6.1 5.6-6.6
HCT % 18.3 16.7-19.9
MCV fL 75.5 69.5-80.5
PLT ×109/L 70 49-91

C3-M (medium value) Control Value Sheet


Lot :B0220 Specification: 2ml
Expiry Date: 2020-06-05
HB-7021
Item Unit
MEAN RANGE
WBC 9
×10 /L 8.0 6.5-9.5
RBC ×1012/L 4.77 4.57-4.97
HGB g/dl 13.7 12.7-14.7
HCT % 40.1 37.1-43.1
MCV fL 85 78-92
PLT ×109/L 258 183-333

C3-H (high value) Control Value Sheet


Lot :B0220 Specification: 2ml
Expiry Date: 2020-06-05
Item Unit
HB 7021
MEAN RANGE
WBC ×109/L 20.3 16.3-24.3
RBC ×1012/L 5.72 5.27-6.17
HGB g/dl 20.9 17.9-22.9
HCT % 54.1 50.10-59.10
MCV fL 94.5 87.5-101.5
PLT ×109/L 530 400-660

You might also like