NAT serum (liquid) reference material
1. Blood source screening quality Run control product series
(1) HBV /HCV/HIV-1 nucleic acid serum (liquid) reference material
|
Number |
Detection system |
Detection mode |
Concentration value (IU/mL) |
Sample loading quantity |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
|||||
|
GBDS-IQC-053-1 |
Roche (The first generation) |
Individual test |
50 |
50 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-2 |
Pooled samplings (6 pooling) |
200 |
1000 |
1000 |
1.0 mL/tube |
6 tubes/set (3 tubes positive +3 tubes negative) |
|
|
GBDS-IQC-053-3 |
Roche (The second generation) |
Individual test |
50 |
50 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-4 |
Pooled samplings (6 pooling) |
50 |
200 |
1000 |
1.0 mL/tube |
6 tubes/set (3 tubes positive +3 tubes negative) |
|
|
GBDS-IQC-053-5 |
Grifols |
Individual test |
30 |
30 |
200 |
1.0 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-6 |
DaAn Gene |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-7 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-8 |
Beijing Wantai |
Pooled samplings (6 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
6 tubes/set (3 tubes positive +3 tubes negative) |
|
GBDS-IQC-053-9 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-10 |
Shanghai Kehua |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-12 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-13 |
Hua Yimei |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-14 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-15 |
Shanghai Haoyuan |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-16 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-24 |
Hunan Sansure |
Pooled samplings (6 pooling) |
50 |
200 |
1000 |
1.0 mL/tube |
6 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-25 |
Individual test |
10 |
30 |
200 |
1.5 mL/tube |
3 tubes/set |
|
(2) HBV/HCV/HIV-1 nucleic acid mixed serum reference material
|
Number |
Serial number |
Concentration value (IU/mL) |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
|||
|
GBDS-BW-102 |
GBW（E）090973 |
(3.4±1.1)×10 |
(3.3±1.2) ×10 |
(2.1±0.6) ×102 |
1.5mL/ tube 20 tubes/kit |
|
GBDS-BW-103 |
GBW（E）090974 |
(5.5±1.4) ×10 |
(5.5±1.4) ×10 |
(5.5±1.4) ×102 |
1.5mL/ tube 20 tubes/kit |
|
GBDS-BW-104 |
GBW（E）090975 |
(5.2±1.3) ×10 |
(5.2±1.3) ×102 |
(5.2±1.3) ×102 |
1.5mL/ tube 20 tubes/kit |
|
GBDS-BW-105 |
GBW（E）090976 |
(2.1±0.4) ×102 |
(1.2±0.3) ×10 3 |
(1.1±0.2) ×10 3 |
1.5mL/ tube 20 tubes/ki |
|
GBDS-BW-106 |
GBW（E）090977 |
(5.1±1.6) ×102 |
(2.1±1.9) ×102 |
(2.2±1.6) ×10 3 |
1.5mL/ tube 20 tubes/ki |
(3) Blood-derived screening for HBV /HCV/HIV-1 nucleic acid serum (liquid) quality Run control products
|
Number |
Concentration value (IU/mL) |
Sample loading quantity |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
|||
|
GBDS-IQC-053-26 |
20 |
20 |
100 |
1.0 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-27 |
30 |
30 |
200 |
1.0 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-28 |
50 |
50 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-29 |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-30 |
50 |
200 |
1000 |
1.0 mL/tube |
6 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-31 |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-32 |
Can be customized according to customer's concentration, parameter specifications. |
||||
(4) Blood-derived screening of HBV /HCV/HIV-1 nucleic acid mixed serum (liquid) quality Run control products
|
Number |
Concentration value (IU/mL) |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
||
|
GBDS-IQC-053-17 |
30 |
30 |
200 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-18 |
50 |
50 |
200 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-19 |
50 |
200 |
200 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-20 |
50 |
200 |
1000 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-21 |
200 |
1000 |
1000 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-22 |
500 |
2000 |
2000 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053 |
500 |
2000 |
2500 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-23 |
Can be customized according to customer's concentration, parameter specifications. |
|||
(5) HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material
(Specification: 3.0mL/ tube 20 tubes/kit)
|
Number |
Serial number |
Concentration value |
|||||||
|
HBsAg IU/mL |
Anti-HIV -1 NCU/mL |
Anti-TP mIU/mL |
Anti-HCV NCU/mL |
||||||
|
Standard value |
Uncertainty |
Standard value |
Uncertainty |
Standard value |
Uncertainty |
Standard value |
Uncertainty |
||
|
GBDS-BW-112 |
GBW（E）090986 |
0.21 |
0.08 |
0.2 |
0.06 |
3.1 |
1.2 |
0.21 |
0.07 |
|
GBDS-BW-113 |
GBW（E）090987 |
0.2 |
0.08 |
0.47 |
0.12 |
5.9 |
1.8 |
0.52 |
0.14 |
|
GBDS-BW-114 |
GBW（E）090988 |
0.5 |
0.09 |
0.52 |
0.13 |
6.3 |
1.8 |
0.51 |
0.14 |
|
GBDS-BW-115 |
GBW（E）090989 |
0.51 |
0.09 |
1 |
0.2 |
11.9 |
3.3 |
1.2 |
0.13 |
|
GBDS-BW-116 |
GBW（E）090990 |
0.51 |
0.09 |
2.04 |
0.27 |
12.4 |
3.4 |
2.04 |
0.17 |
(6) Blood derived screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum (liquid) quality Run control product
|
Number |
Serial number |
Concentration value |
Specification |
|||
|
HBsAg (IU/mL) |
Anti-HCV (NCU/mL) |
Anti-HIV -1 NCU/mL |
Anti-TP mIU/mL |
|||
|
GBDS-I-211-1 |
L1 |
0.15 |
0.03 |
0.2 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-2 |
L2 |
0.15 |
0.05 |
0.2 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-3 |
L3 |
0.2 |
0.05 |
0.5 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-4 |
L4 |
0.2 |
0.5 |
0.5 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-5 |
L5 |
0.5 |
0.05 |
0.5 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-6 |
L6 |
0.2 |
0.05 |
0.5 |
6.0 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-I-211-7 |
L7 |
0.2 |
0.5 |
0.5 |
6.0 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-I-211-8 |
L8 |
0.5 |
0.05 |
0.5 |
6.0 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-I-211-9 |
L9 |
Can be customized according to customer's concentration, parameter specifications. |
||||
(7) Blood-derived screening for HBsAg/ anti-HCV/anti-HIV-1 / anti-TP serum (liquid) quality Run control products
|
Number |
Name |
Number of concentration |
Concentration value |
Specification |
|
GBDS-I-001 |
Hepatitis B virus surface antigen (HBsAg) serum (liquid) indoor quality Run control product |
S1 |
0.1 IU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-002 |
S2 |
0.2 IU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-003 |
S3 |
0.5 IU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-036 |
Human immunodeficiency virus Type 1 antibody (anti-HIV-1) Serum (liquid) indoor quality Run control products |
L1 |
0.2 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-035 |
S0 |
0.5 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-219 |
Antibodies to hepatitis C virus (anti-HCV) serum (liquid) indoor substance Run control products |
L2 |
0.03 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-220 |
L1 |
0.05 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-034 |
S0 |
0.5 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-030 |
Antibody to Treponema pallidum (anti-TP) Serum (liquid) indoor quality Run control products |
S1 |
3.0mIU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-031 |
S2 |
6.0 mIU/mL |
0.5mL/ tube 20 tubes/kit |
2. Novel coronavirus (SARS-CoV-2) nucleic acid quality Run control products
①Raw material source: inactivated fake virus, containing full sequence (including the full length of ORF1ab, N, E, S, M genes), not infectious, no biosafety risk;
②Scope of application: It is an independent and objective third-party quality Run control product, applicable to different testing platforms, different testing methods, applicable to all manufacturers' kits. Including FQ-PCR, thermostatic amplification technology, RNA capture probe method, sequencing method and other methods;
③Quality Run control products need to participate in nucleic acid extraction, which can Run control the quality of the whole process of experimental operation;
④ddPCR method, the quantity value can be traced to the entity number basic unit "1" which can be used as the basic unit of any quantitative system;
⑤Liquid matrix quality Run control material, reduce the uncertainty caused by resolution, stable quality, product validity more than 1 year;
⑥Reference material: belongs to the national second class reference material, reference material number GBW(E)091132/GBW(E)091133;
⑦The negative quality Run control products of the interventricular quality assessment were designed with specific reference products, such as: SARS RNA, MERS RNA, human coronavirus (HCoV RNA) pseudovirus, influenza virus and other analytes.
(1) National secondary standard material
|
Number |
Product Name |
Reference material number |
Mean concentration (copies/μL) |
Specification |
Product Usage |
|
GBDS-BW-117 |
Novel coronavirus (SARS-CoV-2) vacation Viral nucleic acid reference material |
GBW(E)091132 |
(2.0±0.4)E+02 |
0.5mL/ tube, 5 tubes/kit |
Can be used for value transfer; Calibrate and test instruments; Performance evaluation and Run control test methods; Indoor quality Run control; Room quality Run control |
|
GBDS-BW-118 |
GBW(E)091133 |
(2.0±0.4)E+03 |
0.5mL/ tube, 5 tubes/kit |
(2) Indoor Quality Run control (IQC)
|
Number |
Product Name |
Number of concentration |
Mean concentration (copies/mL)
|
Specification |
Product Usage |
|
GBDS-IQC-367 |
The 2019-Novel coronavirus RNA (2019-nCoV) RNA) liquid indoor quality Run control products |
L2 |
250 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 100-200copies/mL |
|
GBDS-IQC-305 |
L1 |
500 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 200-300copies/mL |
|
|
GBDS-IQC-304 |
S0 |
1000 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 350-500copies/mL |
|
|
GBDS-IQC-276 |
S1 (L) |
1500 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 500-1000copies/mL |
|
|
GBDS-IQC-275 |
S2 (M) |
10000 |
0.5mL/ tube, 20 tubes/kit |
/ |
|
|
GBDS-IQC-303 |
S3 (Negative) |
Negative |
0.5mL/ tube, 20 tubes/kit |
/ |
Mutation series quality Run control products
|
Number |
Product Name (Mutant) |
Mean concentration (copies/mL) |
Specification |
|
GBDS-IQC-306 |
Novel coronavirus B.1.1.7 mutant nucleic acid liquid indoor quality Run control product |
5.00E+03
|
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-1 |
Novel coronavirus B.1.351 mutant nucleic acid liquid quality Run control product |
||
|
GBDS-IQC-306-2 |
Novel coronavirus P.1 mutant nucleic acid liquid quality Run control product |
||
|
GBDS-IQC-306-3 |
Novel coronavirus B.1.617 mutant nucleic acid liquid quality Run control product |
||
|
GBDS-IQC-306-4 |
Novel coronavirus Omicron mutant nucleic acid liquid quality Run control product |
Immune series quality Run control products
|
Number |
Product Name |
Specification |
|
GBDS-I-217 |
Novel coronavirus (SARS-CoV-2) antigen quality Run control products |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-218 |
Novel coronavirus (SARS-CoV-2) IgG/IgM antibody quality Run control product |
(3) Room Quality Run control/Blind Sample Quality Assessment (EQA)
|
Number |
Product Name |
Specification |
Composition of Product |
Product Usage |
|
GBDS-EQA-064 |
Interventricular quality assessment of novel coronavirus RNA |
0.5mL/ tube, 5 tubes/set |
Contains specific reference, weak positive, medium positive quality Run control substance |
It can be used for interlaboratory quality assessment |
(4) Performance Verification Reference (PT)
|
Number |
Product Name |
Specification |
Product Composition |
Product Usage |
|
GBDS-EQA-035 |
Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
0.5mL/ tube, 4 tubes/kit |
3 tubes of GBW(E)091132 reference material and 1 tube of 4mL sample diluent |
Can be used for lowest detection limit verification and (or) precision performance verification
|
|
GBDS-EQA-034 |
Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
1.0mL/ tube, 65 tubes/kit |
Including the lowest detection limit verification, analytical specificity Validation, precision validation and positive coincidence rate (correctness verification), interference reference
|
Can be used for minimum detection limit verification, analysis specific verification, precision verification and positive coincidence rate (accuracy test Certification), interference substance verification |
3. Multiple nucleic acid quality Run control series Products for respiratory Pathogens (mixed/combined)
①Raw material source: inactivated culture, no biosafety risk;
②Scope of application: Applicable to different detection platforms, different detection methods, applicable to all manufacturers' kits. Including FQ-PCR, qPCR probe method, digital PCR method, constant temperature amplification technology, RNA capture probe method, sequencing method and other methods. Independent and objective third-party quality Run control products, i.e., Run controls that are not designed or optimized for a particular method or instrument, whose performance is completely independent of the reagent or kit batch number, and can provide an unbiased evaluation of the testing system;
③ Participate in nucleic acid extraction: the whole process of experimental operation can be quality Run control;
④Liquid matrix quality Run control substance: reduced uncertainty caused by resolution, and showed consistent performance compared with clinical samples, without obvious matrix effect;
⑤ Stable performance: special DNA/RNA sample storage diluent for storage, product validity stable for more than 1 year;
⑥ Provide personalized customized services: customized products can be provided according to the detection of different combinations of respiratory pathogens.
(1) Multiple nucleic acid detection of respiratory pathogens indoor quality Run control product - mixed type
|
Number |
Product Name |
Serial number |
Composition of analyte |
Specification |
|
GBDS-IQC-307 |
Respiratory pathogens multiple nucleic acids Test quality Run control products (Mix 1) |
A tube |
Influenza A virus |
0.5mL/ tube, 20 tubes/box (A and B each have 10 tubes)
|
|
Influenza B virus |
||||
|
Respiratory syncytial virus A and B |
||||
|
B tube |
Adenovirus |
|||
|
Rhinoviruses |
||||
|
Mycoplasma pneumoniae |
||||
|
GBDS-IQC-308 |
Respiratory pathogens multiple nucleic acid detection quality Run control products (Mix 2) |
A tube |
Influenza A virus |
0.5mL/ tube, 20 tubes/kit (A and B each have 10 tubes) |
|
Adenovirus |
||||
|
Respiratory syncytial virus A and B |
||||
|
B tube |
Human parainfluenza virus types 1, 2 and 3 |
|||
|
Influenza B virus |
||||
|
GBDS-IQC-309 |
Respiratory pathogens multiple nucleic acid detection quality Run control products (Mix 3) |
\ |
Influenza A virus (H1N1, H3N2, etc.) |
0.5mL/ tube, 20 tubes/kit |
|
Influenza B virus |
||||
|
Respiratory syncytial virus A and B |
||||
|
COVID-19 |
||||
|
GBDS-IQC-310 |
Respiratory pathogens multiple nucleic acid detection quality Run control products (Mix 4) |
\ |
Human parainfluenza virus types 1, 2 and 3 |
0.5mL/ tube, 20 tubes/kit |
|
Adenovirus |
||||
|
Respiratory syncytial virus A and B |
(2) Indoor quality Run control product for multiple nucleic acid detection of respiratory pathogens - combined type
|
Number |
Product Name |
Composition of analyte |
Quantity |
Specification |
|
GBDS-IQC-311 |
Respiratory pathogens multiple nucleic acid detection quality Run control products (Combination A) |
Influenza A virus nucleic acid quality Run control products |
1 tube |
0.5mL/tube 7 tubes/kit
|
|
B influenza virus nucleic acid quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus A nucleic acid quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus B type nucleic acid quality Run control products |
1 tube |
|||
|
Human parainfluenza virus nucleic acid (PIV1 RNA) quality Run control products |
1 tube |
|||
|
Human parainfluenza virus nucleic acid (PIV3 RNA) quality Run control products |
1 tube |
|||
|
Adenovirus nucleic acid (ADV DNA) quality Run control products |
1 tube |
|||
|
GBDS-IQC-312 |
Quality Run control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination B) |
Influenza A virus nucleic acid quality Run control products |
1 tube |
0.5 mL/tube 6 tubes/kit
|
|
B influenza virus nucleic acid quality Run control products |
1 tube |
|||
|
Adenovirus deoxyribonucleic acid (ADV DNA) quality Run control products |
1 tube |
|||
|
Rhinovirus nucleic acid quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus nucleic acid quality Run control products |
1 tube |
|||
|
Mycoplasma pneumoniae nucleic acid (MP DNA) quality Run control |
1 tube |
|||
|
GBDS-IQC-313 |
Quality Run control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination C) |
Influenza A virus nucleic acid quality Run control products |
1 tube |
0.5 mL/tube 7 tubes/kit
|
|
B influenza virus nucleic acid quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus A nucleic acid quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus B type nucleic acid quality Run control products |
1 tube |
|||
|
Novel coronavirus nucleic acid quality Run control products |
1 tube |
|||
|
Influenza A H1N1 virus nucleic acid (HIN1 RNA) quality Run control products |
1 tube |
|||
|
Influenza A H3N2 virus nucleic acid (H3N2 RNA) quality Run control product |
1 tube |
|||
|
GBDS-IQC-314 |
Respiratory pathogens multiple nucleic acid detection quality Run control products (Combination D) |
Human parainfluenza virus nucleic acid (PIV1 RNA) quality Run control products |
1 tube |
0.5 mL/tube 6 tubes/kit |
|
Human parainfluenza virus nucleic acid (PIV2 RNA) quality Run control products |
1 tube |
|||
|
Human parainfluenza virus nucleic acid (PIV3 RNA) quality Run control products |
1 tube |
|||
|
Adenovirus nucleic acid (ADV DNA) quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus A nucleic acid quality Run control products |
1 tube |
|||
|
Respiratory syncytial virus B type nucleic acid quality Run control products |
1 tube |
(3) Room Quality Run control/Blind Sample Quality Assessment (EQA)
|
Number |
Product Name |
Composition of analyte |
Quantity |
Specification |
|
GBDS-EQA-065 |
Interlaboratory quality assessment for multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube 7 tubes/kit
|
It is composed of different pathogen quality Run control products, including positive quality Run control products, negative quality Run control products and specific quality Run control products |
Blind comparison of multiple nucleic acid detection reagents for respiratory pathogens in different laboratories |
Note: Customized products can be provided according to the detection of different combinations of respiratory pathogens.
(4) Performance Verification Reference (PT)
|
Number |
Product Name |
Composition of analyte |
Quantity |
Specification |
|
GBDS-CKP-038 |
Reference for performance verification of multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube |
Different pathogen quality Run control components, including:
Positive coincidence rate, sensitivity (detection limit), specificity, precision, interference substance reference |
Performance verification and evaluation of multiple nucleic acid detection reagents for respiratory pathogens |
Note: Customized products can be provided according to the detection of different combinations of respiratory pathogens.