NAT Run Controls

III. Summary sheet of NAT, nucleic acid Run controls

(I) Certified reference materials

Number

Name

Approval Number

Standard Value

Dimensions

GBDS-BW-001

Human cytomegalovirus DNA

(HCMV DNA) liquid reference material

GBW(E)090676

1.8±0.7E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-002

GBW(E)090677

2.0±0.7E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-003

GBW(E)090678

2.4±0.7E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-004

EB virus DNA

(EBV DNA) liquid reference material

GBW(E)090679

5.0±1.8E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-005

GBW(E)090680

5.1±1.1E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-006

GBW(E)090681

5.4±1.0E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-091

Hepatitis B virus DNA

(HBV DNA) serum (liquid) reference material

GBW(E)090991

(0.5±0.2E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-092

GBW(E)090992

1.0±0.2E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-093

GBW(E)090993

2.1±0.4E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-094

GBW(E)090994

5.1±0.8E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-007

GBW(E)090664

(2.1±0.8E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-008

GBW(E)090665

(2.1±0.7E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-009

GBW(E)090666

(2.0±0.6E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-010

GBW(E)090667

(2.1±0.6E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-095

Hepatitis C virus RNA

(HCV RNA) serum (liquid) reference material

GBW(E) 090978

(0.5±0.2E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-096

GBW(E) 090979

(1.0±0.3E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-097

GBW(E) 090980

(2.1±0.4E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-098

GBW(E) 090981

(5.0±0.8E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-011

GBW(E)090659

( 1.4±0.7) E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-012

GBW(E)090660

( 1.2±0.5) E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-013

GBW(E)090661

( 1.4±0.5) E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-014

GBW(E)090662

( 1.3±0.5) E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-108

Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) reference material

GBW(E)090982

(2.1±0.5E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-109

GBW(E)090983

(5.1±0.8E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-110

GBW(E)090984

(1.1±0.2E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-111

GBW(E)090985

(2.1±0.3E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-015

GBW(E)090663

(2.1±0.6E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-016

HPV16 DNA

(HPV16 DNA) liquid reference material

GBW (E)090668

(1.1±0.3E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-017

GBW (E)090669

1.2±0.3E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-018

GBW (E)090670

1.1±0.2E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-019

GBW (E)090671

1.1±0.2E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-020

HPV18 DNA

(HPV18 DNA) liquid reference material

GBW (E)090672

(1.1±0.4E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-021

GBW (E)090673

(1.1±0.3E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-022

GBW (E)090674

(1.0±0.3E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-023

GBW (E)090675

(1.1±0.3E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-117

Novel Coronavirus (SARS-CoV-2)

Pseudoviral nucleic acid reference material

GBW(E)091132

(2.0±0.4)E+02 copies/μL

0.5mL/ tube,5 tubes/kit

GBDS-BW-118

GBW(E)091133

(2.0±0.4)E+03 copies/μL

0.5mL/ tube,5 tubes/kit

 

(II) The certified reference material for immunity

 

Number

Name

Approval Number

Standard Value

IU/ml

Dimensions

GBDS-BW-051

Hepatitis B virus surface antigen

(HBsAg) serum (fluid) standard

material

GBW(E)090841

(0.23±0.09IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-052

GBW(E)090842

(0.51±0.09IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-053

GBW(E)090843

(5.07±0.64IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-054

GBW(E)090844

(10.0±1.30IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-055

GBW(E)090845

(25.0±3.30IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-056

Hepatitis B virus surface antibody

(HBsAb) serum (liquid) standard

material

GBW(E)090866

(5.1±3.6mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-057

GBW(E)090867

(10.0±3.0mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-058

GBW(E)090868

(24.9±4.1mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-059

GBW(E)090869

(49.8±9.8mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-060

GBW(E)090870

(100±23mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-061

Hepatitis B virus e antigen

(HBeAg) serum (liquid) standard

material

GBW(E)090871

(1.1±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-062

GBW(E)090872

(2.1±0.1NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-063

GBW(E)090873

(4.0±0.4NCU/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                        

 

 

 

 

 

GBDS-BW-064

Hepatitis B virus e antibody

(HBeAb) serum (fluid) standard

material

GBW(E)090846

(1.0±0.6NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-065

GBW(E)090847

(2.1±0.4NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-066

GBW(E)090848

(4.2±0.3NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-067

GBW(E)090849

(8.0±0.8NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-068

Hepatitis B virus core antibody

(HBcAb) serum (liquid) standard

material

GBW(E)090862

(0.5±0.2IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-069

GBW(E)090863

(1.0±0.3IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-070

GBW(E)090864

(1.5±0.4IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-071

GBW(E)090865

(2.0±0.5IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-072

Human immunodeficiency virus

Type 1 antibody (anti-HIV-1)

Serum (liquid) reference material

GBW(E)090858

(1.1±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-073

GBW(E)090859

(2.0±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-074

GBW(E)090860

(4.1±0.3NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-075

GBW(E)090861

(8.0±0.7NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-076

Antibodies to hepatitis C virus

(Anti-HCV) serum (liquid) standard

Quasi material

GBW(E)090854

(1.1±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-077

GBW(E)090855

(2.0±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-078

GBW(E)090856

(4.1±0.3NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-079

GBW(E)090857

(8.0±0.6NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-081

Treponema pallidum antibody (anti -TP) serum (liquid) reference material

GBW(E)090851

(6.0±1.4mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-082

GBW(E)090852

(12.0±2.8mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-083

GBW(E)090853

(18.1±4.2mIU/mL

0.5mL/ tube, 20 tubes/kit