Mindray CLIA Cal and QC Storage Method

Items that their calibrators do not need to be aliquoted and frozen:

When calibration, take the calibrator out from 2-8℃, mix well, aspirate

the required amount into the sample cup, and immediately put the

remaining calibrator back to 2-8℃.

AFP、CEA、CA125、CA15-3、CA19-9、FPSA、t-PSA、FERR

FT3 、 FT4 、 T3 、 T4 、 rT3 、 PCT 、 PIIINP 、 CIV 、 HA 、 LN 、 PG

I、PG II、CA50，CA242、HE4、SCCA、ProGRP；

Total β HCG、FSH、LH、TESTO、PROG、E2、E3；

HBsAg、Anti-HBs、HBeAg、Anti-HBe、Anti-HBc、HIV；

Insulin、C-Peptide、DHEA-S、Cortisol、Tg、Anti-Tg、Anti-TPO；

CA72-4 、 CYFRA21-1 、 Anti-HCV 、 Anti-TP 、 ALD 、 nCoV

NTAb、nCoV S-RBD、nCoV TAb；

Items that their calibrators need to be aliquoted and frozen:

After the calibrator is opened, use the EP tube to aliquot it (one aliquot is

the volume required for one calibration + dead volume), and then store it
at -20°C. Take it out before use and equilibrate to room temperature.

TSH、PRL

Items that their calibrators need to be reconstituted, aliquoted and

frozen:

Troponin I 、 BNP 、 Myoglobin 、 CK-

MB、ACTH、NSE、Renin、AMH

Reconstitution and storage method of calibrator:

1. Take out the calibrator and equilibrate for 15-30 minutes to the room

temperature. Place the lyophilized bottle vertically to ensure that the

powder remains at the bottom of the bottle.

2. Unscrew the outer cover and carefully remove the rubber stopper. Place

the rubber stopper upside down on a clean surface.

3. Use the calibrated pipette to accurately aspirate distilled water or

deionized water according to the instructions, and carefully add it to the

bottle along the bottle wall.

4. Cover the rubber stopper and balance for 20-30 minutes. During this

period, it needs to be inverted and mixed repeatedly to ensure that all

powder is completely dissolved and no bubble is formed.

5. Dissolve the reconstituted and mixed calibrator evenly, aliquot it with

EP tube (one aliquot is the volume required for one calibration + dead

volume), then store at -20°C. Take it out before use and equilibrate to

room temperature.

QC storage:

After unpacking the QC product, mix the QC materials of different

bottles in the dispensing container evenly, use EP tubes for aliquot (one

aliquot is the volume required for one QC + dead volume), and then store

at -20°C. Take it out before use and equilibrate to room temperature.

For the SARS-CoV-2 antibody QC products, there is no need to aliquot

and freeze them. Take it out from 2-8℃ during use, mix well and aspirate
the required amount into the sample cup, immediately put the remaining

QC products back to 2-8℃; or insert the original tube into the sample

rack directly on the machine, close the bottle cap immediately after

aspiration, put the remaining QC products back to 2-8℃.

Lyophilized powder QC products storage:

Involved product: ACTH QC, NSE QC, cardiac marker QC, hypertension

QC and AMH QC.

QC product reconstitution and storage method:

1. Take out the QC and equilibrate for 15-30 minutes to room

temperature. Place the lyophilized bottle vertically to ensure that the

powder remains at the bottom of the bottle.

2. Unscrew the outer cover and carefully remove the rubber stopper. Place

the rubber stopper upside down on a clean surface.

3. Use a calibrated pipette to accurately aspirate distilled water or

deionized water according to the instructions, and carefully add it to the

bottle along the bottle wall.

4. Cover the rubber stopper and balance for 20-30 minutes. During this

period, it needs to be inverted and mixed repeatedly to ensure that all

powder is completely dissolved and no bubble is formed.

5. Dissolve the reconstituted and evenly mixed QC, aliquot it with EP

tubes (one aliquot is the volume required for one QC + dead volume), and

then store at -20°C. Take it out before use and equilibrate to room

temperature.
Tumor Marker

Opened
Target Value Unopened Stability (2- Bottle Capacity/ Aspiration
Calibrator Frequency Stability (2- Frozen Storage
C0/C1/C2 8 ℃) Volume
8 ℃)

1. When Within the validity

AFP ≈0/5/500 ng/ml 3 months — 2 ml/ 20 μl
necessary, period

such as the Within the validity

CEA ≈0/10/500 ng/ml 3 months — 2 ml/ 8 μl
QC is out of period

range; Within the validity

CA125 ≈0/100/2000 U/ml 3 months — 2 ml/ 15 μl
2. When period

changing the Within the validity

CA15-3 ≈0/50/250 U/ml 3 months — 2 ml/ 5 μl
reagent lot; period

3. When the Within the validity

CA19-9 ≈0/90/900 U/ml 3 months — 2 ml/ 20 μl
calibration period

is expired Within the validity

FPSA ≈0/2/15 ng/ml 3 months — 2 ml/ 15 μl
for the same period

t-PSA lot of the ≈0/2/60 ng/ml Within the validity 3 months — 2 ml/ 20 μl
 reagent. period

Within the validity

FERR ≈0/50/500 ng/ml 3 months — 2 ml/ 20 μl
period

Within the validity

CA72-4 ≈0/20/100 U/ml 2 months — 2 ml/ 8 μl
period

Within the validity

Cyfra 21-1 ≈0/10/150 ng/ml 2 months — 2 ml/ 10 μl
period

Within the validity

NSE ≈0/10/125 ng/ml 2 months — 2 ml/ 5 μl
period

Within the validity 2 months —

CA50 ≈0/20/200 U/ml C0: 1.2 ml; C1、C2: 1.0mL /25 μl
period

Within the validity 2 months —

CA242 ≈0/10/70 U/ml C0: 1.2 ml; C1、C2: 1.0mL /25 μl
period

Within the validity 2 months —

HE4 ≈0/70/500 pmol/L C0: 1.2 ml; C1、C2: 1.0mL /5 μl
period

Within the validity 2 months —

SCCA ≈0/2/20 ng/ml C0: 1.2 ml; C1、C2: 1.0mL /35 μl
period

ProGRP ≈0/40/800 pg/ml Within the validity 2 months — C0: 1.2 ml; C1、C2: 1.0mL /25 μl
 period

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume
Fertility
Bottle Capacity/
Unopened Stability Opened Stability
Calibrator Frequency Target Value C0/C1/C2 Frozen Storage Aspiration
(2-8℃) (2-8℃)
Volume
Within the validity
Total β HCG ≈0/50/4500 mIU/ml 3 months — 2 ml/ 15 μl
period
Within the validity
FSH ≈0/10/100 mIU/ml 3 months — 2 ml/ 30 μl
period
Within the validity
LH ≈0/10/100 mIU/ml 3 months — 2 ml/ 20 μl
period
1. When necessary, Within the validity 1 time: -20℃ 3
PRL ≈0/10/100 ng/ml 2 months 2 ml/ 15 μl
such as the QC is period months
out of range; Within the validity
TESTO 2. When changing ≈0/1.5/16 ng/ml 3 months — 2 ml/ 25 μl
period
the reagent lot; Within the validity
PROG 3. When the ≈0/4/40 ng/ml 3 months — 2 ml/ 30 μl
period
calibration is Within the validity
E2 expired for the ≈0/500/4800 pg/ml 3 months — 2 ml/ 35 μl
period
same lot of the Within the validity
E3 reagent. ≈0/2/30 ng/ml 3 months — 2 ml/ 25 μl
period
Within the validity
Cortisol ≈0/5/55 μg/dl 2 months — 2 ml/10 μl
period
Within the validity
DHEA-S ≈0/20/500 μg/dl 2 months — 2 ml/10 μl
period
ACTH ≈0/100/1000 pg/ml Within the validity 7 days 1 time: -20℃ 2 2 ml/50 μl
 period months
Within the validity C0: 0.6 ml;
AMH ≈0/0.2/8 ng/ml 8h 1 time: -20℃ 28 days C1、C2: 0.5mL
period /50 μl

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume
Thyroid

Unopened Stability Opened Stability Bottle Capacity/

Calibrator Frequency Target Value C0/C1/C2 Frozen Storage
(2-8℃) (2-8℃) Aspiration Volume

Within the validity

TSH ≈0/0.5/40 μIU/ml 2 months 1 time: -20℃ 3 months 2 ml/ 115 μl
period

1. When Within the validity

FT3 ≈0/2/30 pg/ml 3 months — 2 ml/ 35 μl
necessary, such as period
the QC is out of
range; Within the validity
FT4 ≈0/1/6 ng/dl 3 months — 2 ml/ 20 μl
2. When changing period
the reagent lot;
3. When the Within the validity
T3 ≈0/1/8 ng/ml 3 months — 2 ml/ 55 μl
calibration is period
expired for the
same lot of the Within the validity
T4 ≈0/3/30 μg/dl 3 months — 2 ml/ 35 μl
reagent. period

Within the validity

Tg ≈0/10/200 ng/ml 2 months — 2 ml/ 10 μl
period
 Within the validity
Anti-Tg ≈0/100/1000 IU/ml 2 months — 2 ml/ 15 μl
period

Within the validity

Anti-TPO ≈0/20/300 IU/ml 2 months — 2 ml/ 15 μl
period

Within the validity

rT3 ≈0/1/9 ng/mL 30 days — 1 ml/ 20 μl
period

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume
Infectious Disease
Unopened Stability Opened Stability Bottle Capacity/
Calibrator Frequency Target Value C0/C1/C2 Frozen Storage
(2-8℃) (2-8℃) Aspiration Volume
Within the validity
HBsAg ≈0/5/100 IU/ml 1 month — 2 ml/ 55 μl
period
Within the validity
Anti-HBs ≈0/50/500 mIU/ml 1 month — 2 ml/ 55 μl
period
Within the validity
HBeAg Negative/Positive 1 month — 2 ml/ 55 μl
period
1. When
Within the validity
Anti-HBe necessary, such as Negative/Positive 1 month — 2 ml/ 55 μl
period
the QC is out of
Within the validity
Anti-HBc range; Negative/Positive 1 month — 2 ml/ 55 μl
period
2. When changing
Within the validity
HIV the reagent lot; Negative/Positive 1 month — 2 ml/ 105 μl
period
3. When the
Within the validity
Anti-TP calibration is Negative/Positive 2 months — 2 ml/ 45 μl
period
expired for the
Within the validity
Anti-HCV same lot of the Negative/Positive 2 months — 2 ml/ 55 μl
period
reagent.
Within the validity —
nCoV NTAb ≈0/20/350 AU/ml 30 days 0.5 ml/ 10 μl
period
Within the validity — C0: 0.6 ml; C1、C2:
nCoV S-RBD ≈0/20/400 AU/ml 30 days
period 0.5mL /10 μl
Within the validity — C0: 0.6 ml; C1、C2:
nCoV TAb ≈0/20/350 AU/ml 30 days
period 0.5mL /10 μl
Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume

Cardiac Marker

Bottle Capacity/
Unopened Opened Stability
Calibrator Frequency Target Value C0/C1/C2 Frozen Storage Aspiration
Stability (2-8℃) (2-8℃)
Volume

Within the validity 1 time: -20℃ 2

Troponin I 1. When necessary, ≈0/0.5/10 ng/ml 8 hours 2 ml/ 75 μl
period months
such as the QC is out of
range;
2. When changing the Within the validity 1 time: -20℃ 2
BNP ≈0/300/2500 pg/ml 48 hours 2 ml/ 100 μl
reagent lot; period months
3. When the calibration
is expired for the same Within the validity 1 time: -20℃ 2
CK-MB lot of the reagent. ≈0/15/200 ng/ml 2 months 2 ml/ 10 μl
period months
 Within the validity 1 time: -20℃ 2
Myoglobin ≈0/250/1500 ng/ml 6 days 2 ml/ 5 μl
period months

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume

Diabetes

Bottle Capacity/
Target Value Unopened Stability Opened Stability
Calibrator Frequency Frozen Storage Aspiration
C0/C1/C2 (2-8℃) (2-8℃)
Volume
1. When necessary, such as
the QC is out of range;
Within the validity
Insulin 2. When changing the ≈0/25/500 μIU/ml 2 months — 2 ml/10 μl
period
reagent lot;
3. When the calibration is
expired for the same lot of Within the validity
C-Peptide ≈0/0.5/10 ng/ml 2 months — 2 ml/ 10 μl
the reagent. period
Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume

Inflammation

Bottle Capacity/
Target Value Unopened Stability Opened Stability
Calibrator Frequency Frozen Storage Aspiration
C0/C1/C2 (2-8℃) (2-8℃)
Volume
1. When necessary, such as
the QC is out of range;
2. When changing the C0: 1.2 ml;
Within the validity
PCT reagent lot; ≈0/0.5/20 ng/ml 30 days — C1、C2: 1.0mL
period
3. When the calibration is /25 μl
expired for the same lot of
the reagent.

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume

Liver Fibrosis

Bottle Capacity/
Target Value Unopened Stability Opened Stability
Calibrator Frequency Frozen Storage Aspiration
C0/C1/C2 (2-8℃) (2-8℃)
Volume

C0: 0.6 ml;

Within the validity
PIIINP ≈0/15/60 ng/ml 30 days — C1、C2: 0.5mL /5
period
μl
1. When necessary, such as
the QC is out of range;
C0: 0.6 ml;
2. When changing the Within the validity
CIV ≈0/100/500 ng/ml 30 days — C1、C2: 0.5mL
reagent lot; period
/20 μl
3. When the calibration is
expired for the same lot of
the reagent.
Within the validity
HA ≈0/150/1800 ng/ml 30 days — 1 ml/ 100 μl
period
 C0: 0.6 ml;
Within the validity
LN ≈0/100/400 ng/ml 30 days — C1、C2: 0.5mL
period
/25 μl

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume

Gastritis

Bottle Capacity/
Target Value Unopened Stability Opened Stability
Calibrator Frequency Frozen Storage Aspiration
C0/C1/C2 (2-8℃) (2-8℃)
Volume

1. When necessary, such as

C0: 1.2 ml;
the QC is out of range; Within the validity
PG I ≈0/20/100 ng/ml 30 days — C1、C2: 1.0
2. When changing the period
mL /5 μl
reagent lot;
 3. When the calibration is C0: 1.2 ml;
Within the validity
PG II expired for the same lot of ≈0/10/50 ng/ml 30 days — C1、C2: 1.0
period
the reagent. mL /10 μl

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume
Anemia & bone metabolism

Bottle Capacity/
Unopened Stability Opened Stability (2- Frozen
Calibrator Frequency Target Value C0/C1/C2 Aspiration
(2-8℃) 8 ℃) Storage
Volume
Within the validity
VD-T ≈0/20/140 ng/ml 1 month — 2 ml/40 μl
period
1. When necessary, such as
Within the validity
Folate the QC is out of range; ≈0/2.5/20 ng/ml 1 month — 2 ml/80 μl
period
2. When changing the
Within the validity
VB12 reagent lot; ≈0/200/2000 pg/ml 1 month — 2 ml/50 μl
period
3. When the calibration is
Within the validity
PTH expired for the same lot of ≈0/150/2400 pg/ml 1 month — 2 ml/30 μl
period
the reagent.
Within the validity
CT ≈0/100/1000 pg/ml 1 month — 2 ml/30 μl
period

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume
Hypertension

Bottle Capacity/
Target Value Unopened Stability
Calibrator Frequency Opened Stability Frozen Storage Aspiration
C0/C1/C2 (2-8℃)
Volume

C0: 1.2 ml;

1. When necessary, such as Within the validity -20℃ and below,
Renin ≈0/25/250 pg/ml — C1、C2: 1.0
the QC is out of range; period 30 days
mL /105 μl
2. When changing the
reagent lot;
3. When the calibration is
C0: 1.0 ml;
expired for the same lot of Within the validity
ALD ≈0/100/1500 pg/ml 2~8℃, 30 days — C1、C2: 1.0
the reagent. period
mL /105 μl

Note:

"—" means no information.

Suggested allocation volume for one-time consumption=3* Aspiration volume + Dead volume
Control

Unopened Stability (2- Opened Stability

Control Level Specification Frozen Storage
8 ℃) (2-8℃)

2 Levels,
Thyroid Function Multi Within the validity
6 or 12 bottles for one 5.0 ml /bottle 30 days 1 time: -20℃ 3 months
Control period
level

2 Levels,
Within the validity
Tumor Marker Multi Control 6 or 12 bottles for one 5.0 ml /bottle 30 days 1 time: -20℃ 3 months
period
level

2 Levels,
Within the validity
Reproductive Multi Control 6 or 12 bottles for one 5.0 ml /bottle 30 days 1 time: -20℃ 3 months
period
level

2 Levels, 3 or 6 bottles Within the validity

HBsAg Control 2.0 ml /bottle 30 days —
for one level period
 2 Levels, 3 or 6 bottles Within the validity
Anti-HBs Control 2.0 ml /bottle 30 days —
for one level period

2 Levels, 3 or 6 bottles Within the validity

HBeAg Control 2.0 ml /bottle 30 days —
for one level period

2 Levels, 3 or 6 bottles Within the validity

Anti-HBe Control 2.0 ml /bottle 30 days —
for one level period

2 Levels, 3 or 6 bottles Within the validity

Anti-HBc Control 2.0 ml /bottle 30 days —
for one level period

3 Levels
Negative:3 or 6 bottles
for one level Within the validity
HIV Ag&Ab Control 2.0 ml /bottle 30 days —
Antigen positive and period
antibody positive: 3 or 6
bottles for each level
Cardiac Marker Multi Control 2 Levels, 3 or 6 bottles 2.0 ml /bottle Within the validity Troponin I: 24 hours 1 time: -20℃ 2 months
for one level period BNP: 24 hours
CK-MB: 30 days
 Myo: 2 days

Anti-thyroid Antibodies 2 Levels, 3 or 6 bottles Within the validity

2.0 ml /bottle 2 months —
Control for one level period

2 Levels, 3 or 6 bottles Within the validity

Immunoassay Multi Control 2.0 ml /bottle 2 months —
for one level period

2 Levels, 3 or 6 bottles Within the validity

ACTH Control 2.0 ml /bottle 7 days 1 time: -20℃ 2 months
for one level period

2 Levels, 3 or 6 bottles Within the validity

NSE Control 2.0 ml /bottle 2 months 1 time: -20℃ 2 months
for one level period

2 Levels, 3 or 6 bottles Within the validity

Liver Fibrosis Multi Control 2.0 ml /bottle 30 days —
for one level period

2 Levels, 3 or 6 bottles Within the validity

rT3 Control 1.0 ml /bottle 30 days —
for one level period
 2 Levels, 3 or 6 bottles Within the validity
PCT Control 2.0 ml /bottle 30 days —
for one level period

2 Levels, 3 or 6 bottles Within the validity

Gastritis Multi Control 2.0 ml /bottle 30 days —
for one level period

Tumor Marker Multi Control 2 Levels, 3 or 6 bottles Within the validity

2.0 ml /bottle 2 months —
II for one level period

2 Levels, 3 or 6 bottles Within the validity

ProGRP Control 1.0 ml /bottle 2 months —
for one level period

2 Levels, 3 or 6 bottles Within the validity

Hypertension Muti Control 2.0 ml /bottle 12 hours 1 time: -20℃ 30 days
for one level period

2 Levels, 3 or 6 bottles Within the validity

Metabolic Multi Control 2.0 ml /bottle — 1 time: -20℃ 1 months
for one level period
 2 Levels, 3 or 6 bottles Within the validity
AMH Control 2.0 ml /bottle — 1 time: -20℃ 30 days
for one level period

2 Levels, 3 or 6 bottles Within the validity

SARS-CoV-2 NTAb Control 0.5ml /bottle 30 days —
for one level period

SARS-CoV-2 S-RBD IgG 2 Levels, 3 or 6 bottles Within the validity

0.5ml /bottle 30 days —
Control for one level period

2 Levels, 3 or 6 bottles Within the validity

SARS-CoV-2 Tab Control 0.5ml /bottle 30 days —
for one level period

Note:

"—" means no information.