Product Cluster

1. Blood source screening quality Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr control products

Number

Name

Number of concentration

Concentration value

Specification

GBDS-I-001

Hepatitis B virus surface antigen

(HBsAg) serum (liquid) indoor quality Pcr 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 Pcr 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

Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr control products need to participate in nucleic acid extraction, which can Pcr 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 Pcr 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 Pcr 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 Pcr control test methods; Indoor quality Pcr control; Room quality Pcr control

GBDS-BW-118

GBW(E)091133

(2.0±0.4)E+03

0.5mL/ tube, 5 tubes/kit

 

(2) Indoor Quality Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr control product

GBDS-IQC-306-2

Novel coronavirus P.1 mutant nucleic acid liquid quality Pcr control product

GBDS-IQC-306-3

Novel coronavirus B.1.617 mutant nucleic acid liquid quality Pcr control product

GBDS-IQC-306-4

Novel coronavirus Omicron mutant nucleic acid liquid quality Pcr control product

 

 

Immune series quality Pcr control products

Number

Product Name

Specification

GBDS-I-217

Novel coronavirus (SARS-CoV-2) antigen quality Pcr control products

 

0.5mL/ tube, 20 tubes/kit

GBDS-I-218

Novel coronavirus (SARS-CoV-2) IgG/IgM antibody quality Pcr control product

 

 

(3) Room Quality Pcr 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 Pcr 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 Pcr 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 Pcr control products, i.e., Pcr 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 Pcr control;

④Liquid matrix quality Pcr 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 Pcr control product - mixed type

Number

Product Name

Serial number

Composition of analyte

Specification

GBDS-IQC-307

Respiratory pathogens multiple nucleic acids Test quality Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr control products

(Combination A)

Influenza A virus nucleic acid quality Pcr control products

1 tube

 

 

 

 

 

0.5mL/tube

7 tubes/kit

 

B influenza virus nucleic acid quality Pcr control products

1 tube

Respiratory syncytial virus A nucleic acid quality Pcr control products

1 tube

Respiratory syncytial virus B type nucleic acid quality Pcr control products

1 tube

Human parainfluenza virus nucleic acid (PIV1 RNA) quality Pcr control products

1 tube

Human parainfluenza virus nucleic acid (PIV3 RNA) quality Pcr control products

1 tube

Adenovirus nucleic acid (ADV DNA) quality Pcr control products

1 tube

 

 

 

 

GBDS-IQC-312

Quality Pcr control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination B)

Influenza A virus nucleic acid quality Pcr control products

1 tube

 

 

 

0.5 mL/tube

6 tubes/kit

 

B influenza virus nucleic acid quality Pcr control products

1 tube

Adenovirus deoxyribonucleic acid (ADV DNA) quality Pcr control products

1 tube

Rhinovirus nucleic acid quality Pcr control products

1 tube

Respiratory syncytial virus nucleic acid quality Pcr control products

1 tube

Mycoplasma pneumoniae nucleic acid (MP DNA) quality Pcr control

1 tube

 

 

 

GBDS-IQC-313

Quality Pcr control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination C)

Influenza A virus nucleic acid quality Pcr control products

1 tube

 

 

 

0.5 mL/tube

7 tubes/kit

 

B influenza virus nucleic acid quality Pcr control products

1 tube

Respiratory syncytial virus A nucleic acid quality Pcr control products

1 tube

Respiratory syncytial virus B type nucleic acid quality Pcr control products

1 tube

Novel coronavirus nucleic acid quality Pcr control products

1 tube

Influenza A H1N1 virus nucleic acid (HIN1 RNA) quality Pcr control products

1 tube

Influenza A H3N2 virus nucleic acid (H3N2 RNA) quality Pcr control product

1 tube

 

 

 

 

GBDS-IQC-314

Respiratory pathogens multiple nucleic acid detection quality Pcr control products

(Combination D)

Human parainfluenza virus nucleic acid (PIV1 RNA) quality Pcr control products

1 tube

 

 

 

0.5 mL/tube

6 tubes/kit

Human parainfluenza virus nucleic acid (PIV2 RNA) quality Pcr control products

1 tube

Human parainfluenza virus nucleic acid (PIV3 RNA) quality Pcr control products

1 tube

Adenovirus nucleic acid (ADV DNA) quality Pcr control products

1 tube

Respiratory syncytial virus A nucleic acid quality Pcr control products

1 tube

Respiratory syncytial virus B type nucleic acid quality Pcr control products

1 tube

 

 

(3) Room Quality Pcr 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 Pcr control products, including positive quality Pcr control products, negative quality Pcr control products and specific quality Pcr 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 Pcr 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.


Biomics​ abbreviations

  • CDC center of disease control
    DBS dried blood spots
    EIA enzyme immunoassay
    Elisa enzyme-linked immunosorbent assay
    HBV hepatitis B virus
    HBsAg hepatitis B surface antigen
    anti-HBs antibody to HBsAg
    anti-HBc antibody to HBcAg
    IgM anti-HBc IgM class antibody to HBcAg (detected in acute infection)
    IgG anti-HBc IgG class antibody to HBcAg (detected in chronic infection)
    HBeAg hepatitis B e antigen
    anti-HBe antibody to HBeAg
    HBVDNA hepatitis B virus desoxyribonucleic acid
    HCV hepatitis C virus
    anti-HCV antibody to HCV
    HIV human immunodeficiency virus
    IDU intravenous drug user
    IFA immuno fluorescent antibody assay
    LIA line immunoassay
    PCR polymerase chain reaction
    RIBA recombinant immunoblot assay
    RIPA radio-immuno precipitation assay
    RT-PCR reverse transcription – polymerase chain reaction
    TMA transcription-mediated amplification



NAT tests for HIV, HBV and HCV infections


1. Biological testing
HIV
The diagnosis of HIV infection is usually based on the detection of antibodies to HIV. Most people
develop detectable antibodies within 3 months after infection, the average being 25 days; in rare
cases, it can take up to 6 months.
In clinical settings, HIV is generally diagnosed using first an ELISA test, as screening test, and then
a Western blot test, as confirmatory test if the ELISA test is found to be positive. Testing is
generally carried out in accredited reference laboratories on blood samples collected by venous
puncture. Based on literature review, the sensitivity and specificity of ELISA and Western blot tests
exceed 99%. Rapid tests have also been developed to diagnose HIV infection : they allow
laboratory analyses and medical counseling to be completed in a single visit, at least for negative
cases. Because rapid tests are generally carried out in small laboratories, positive and equivocal
results must be confirmed, requiring that a blood sample should be sent to an accredited reference
laboratory, where it will undergo confirmatory testing. Licensed kits used for rapid HIV testing have
the same sensitivity, specificity, and performance characteristics as screening methods currently
used in reference laboratories. At least for now, rapid HIV screening tests will only be licensed for
use by health-care professionals at the “point of care”. Advantages of rapid HIV screening tests
include:
(i) improvement of clients’ satisfaction who can rapidly receive their results;
(ii) easier and safer to use,
(iii) enhancement of the autonomy of people to be tested since they will be able to chose
between conventional testing and rapid testing,
(iv) more people would receive their results (only one medical counselling).
In the context of epidemiological surveys, blood sampling through venous puncture can be
expensive and raises several practical problems, which have to be taken into consideration before
implementing the survey. Blood sampling requires a trained medical staff as well as needles,
syringes, and collection tubes. Safety issues must be considered. Compared to saliva, venous
puncture increases the risk of infection for health-care workers and laboratory technicians through
inadvertent contact with infected blood (higher concentration of antigens in blood, possible
wounding due to the use of sharp collecting devices, and handling of tubes containing
contaminated blood). However, blood sampling may reduce participation and raises concern about
selection bias. In addition, venous puncture among injecting drugs users is often difficult because
access to vein is poor. Blood samples also need appropriate handling in order to avoid haemolysis
and bacterial contamination (maintenance of the cold chain is required if transfer to the laboratory
exceeds 24 hours after the collection). However, the use of whole blood, serum, or plasma has two
main advantages :
(i) a better screening of positive cases owing to the higher concentration of HIV antibodies
in blood compared to oral fluids or urine, and
(ii) the possibility to carry out confirmatory testing and/or additional laboratory analyses
with the same sample (HBV and HCV, e.g.).


  • In addition, more specialised laboratory analyses can eventually be considered (HIV typing, HIV
    sub-typing, antiretroviral resistance, e.g.). Blood sampling by venous puncture can be easily
    carried out when participating drug users are recruited in clinical settings.
    Whole blood can also be collected by finger stick, a less invasive blood collection method. Dried
    blood spots (DBS) can then be collected on filter paper. DBS samples have the advantage of being
    easily transported, safer, and, at least, do not, temporally, require cold storage. Testing methods
    used for DBS samples appear to have a slightly lower sensibility and specificity (87-99%).
    Collection however requires some training.
    Saliva which also contains HIV antibodies is an alternative to blood testing. However,
    concentration of HIV antibodies in saliva is lower compared to that found in blood. In numerous
    studies, several oral fluid tests have proved to be, in some cases, as valid as a standard EIA blood
    test. Saliva tests have been recommended and used for population surveys, surveillance
    programs, and personal screening. Advantages of HIV tests carried out on oral fluid samples
    include:
    (i) ease of sampling collection (no need for medically trained staff) making it possible to
    collect samples in a variety of field settings, including non-clinical settings,
    (ii) contact with contaminated sampled fluids is minimized,
    (iii) greater acceptability for hard-to-reach populations compared to venous puncture.
    Two main disadvantages should however be considered when using saliva as testing sample :
    (i) confirmation of positive cases by testing saliva samples requires an additional blood
    sample, and
    (ii) the concentration of antibodies in saliva samples may not be sufficient to detect truly
    positive cases.
    In addition, the laboratory technique should be validated, i.e. the laboratory must ensure that the
    technique is able to reproduce previous published values on sensitivity and specificity. Currently,
    validated techniques are not widely spread. Quality control of the analytical methods can also be a
    problem since large volumes of saliva are much more difficult to obtain than blood. Saliva tests
    seem to be slightly less sensitive and specific than blood tests : based on a literature review,
    sensitivity and specificity of saliva tests range from 84 to 100%.
    Currently, no truly "rapid" test using urine samples is available on the market, although
    technological advances may soon change this. Actually, urine EIA tests are less sensitive and less
    specific than blood-bases test, may require an additional specimen for confirmation and cannot be
    used to perform additional testing for special studies.
    Three criteria should be considered for choosing an HIV testing strategy :
    (i) objective of the testing : transfusion/transplant safety, epidemiological surveillance or
    HIV diagnosis,
    (ii) sensitivity and specificity of the tests being used, and
    (iii) HIV prevalence in the studied population.
    Three strategies are recommended :
    (i) one test for use in transfusion/transplant safety whatever the HIV prevalence rate, in
    HIV diagnosis in populations with HIV prevalence higher than 30% among persons with
    clinical signs or symptoms of HIV infection, and in epidemiological surveillance in
    populations with an HIV prevalence higher than 10%;
    (ii) two tests for use in HIV diagnosis in populations with HIV prevalence lower than 30%
    among persons with clinical signs or higher than 10% among asymptomatic persons,
    and in epidemiological surveillance in populations with an HIV prevalence lower than
    10%;
    (iii) three tests for use in HIV diagnosis in populations with HIV prevalence lower than 10%
    among asymptomatic persons.


When HIV testing strategies involve more than one test, the selection of laboratory techniques in
terms of sensitivity and specificity and the order in which they are used are important for obtaining
valid results. First, the reagents used in the tests should contain different antigens. Second, the
first test, also called the screening test, should be as sensitive as possible in order to detect all
positive cases. The second test, called the confirmatory test, should be as specific as possible in
order to ensure that all truly negative cases are identified. Testing on serum, plasma, or dried
blood spots is therefore recommended since confirmatory testing can be carried out on a single
sample, avoiding the collection of additional blood sample.
HBV
The diagnosis of HBV infection is generally made on the basis of serological markers detected by
ELISA assay. Serologic markers of HBV infection vary depending on whether the infection is acute
or chronic.
In acute HBV infections, hepatitis B surface antigen (HBsAg) is the first serologic marker to appear
in blood. It can be detected as early as 1 or 2 weeks and as late as 11 or 12 weeks after infection
by HBV. In persons who recover, HBsAg is no longer detectable in serum after an average period
of about 3 months. Hepatitis B antigen (HBeAg) is generally detectable in patients with acute
infection; its presence in serum correlates with higher concentrations of HBV and greater
infectivity. Antibodies against HBeAg (Anti-HBe) becomes detectable during convalescence, after
the disappearance of HBeAg, and remains detectable, generally 1 or 2 years after infection. Acute
HBV infection can also be diagnosed on the basis of the detection of IgM class antibody to
hepatitis B core antigen (IgM anti-HBc) in serum; IgM anti-HBc is generally detectable at the time
of clinical onset and declines to sub-detectable levels within 6 months. IgG anti-HBc persist
indefinitely as a marker of past infection. Anti-HBs, antibodies to hepatitis B surface antigen,
become detectable during convalescence after the disappearance of HBsAg in patients who do not
progress to chronic infection. The presence of anti-HBs following acute infection generally
indicates recovery and immunity from re-infection.
In chronic HBV infection, HBsAg is detected in serum for at least 6 months and is associated to the
absence of IgM anti-HBc. Both HBsAg and IgG anti-HBc remain persistently detectable, generally
for life. HBeAg is variably present in these patients: level of viral activity or replication is assessed
by testing for hepatitis Be antigen (HBeAg) and hepatitis B DNA (HBV DNA) in the serum. In most
cases, the chronic infection becomes "non-replicative" and the subjects lose serum HBeAg and
develop antibodies against HBeAg. In some cases, "replicative" infection persists along with
detectable serum HBeAg. In chronically infected individuals, infection can switch from "nonreplicative" to "replicative" and vice-versa.
Biological tests routinely carried out include anti-HBc (blood and saliva), HBsAg (blood and dried
blood spots), anti-HBs (blood) and IgM anti-HBc (blood).
Based on a literature review, the sensitivity and specificity of the different biomarkers of HBV are
as follows :
- anti-HBc in saliva : 82 for sensitivity and more than 99% for specificity,
- HBsAg in DBS : 99%, both for sensitivity and specificity,
- HBsAg in blood : more than 99 % both,
- anti-HBc in blood : more than 80% for sensitivity and 90-99% for specificity,
- IgM anti-HBc in blood : 99 % both, and
- anti-HBs in blood : 99 % both.


HCV
Testing for the presence of antibodies to Hepatitis C virus (anti-HCV) is recommended for
identifying persons with hepatitis C viral infection. Anti-HCV testing includes initial screening with
an immunoassay. A negative screening result is interpreted as anti-HCV negative; typically,
persons whose anti-HCV test results are negative are considered uninfected. A positive screening
result should ideally be verified with an independent additional test having high specificity (RIBA or
a nucleic acid test). Currently, the majority of laboratories report a positive result based on a
positive screening test result only, and do not confirm these results with more specific serologic or
nucleic acid testing. Multiple reasons exist regarding why laboratories do not perform additional
testing for anti-HCV, including lack of an established laboratory standard for such testing, lack of
understanding regarding the performance and interpretation of the screening and additional HCV
test, and the high cost of the additional HCV test. In certain clinical settings, false positive anti-HCV
results are rare because the majority of patients being tested have evidence of liver disease and
the specificity of ELISA test is high (more than 99 %). The sensitivity of ELISA test is also very
high: more than 95 %.
Recent studies using saliva and DBS for anti-HCV testing reported high sensitivity and specificity :
for DBS, sensitivity ranging from 95 to 99 % and specificity from 99 to 100%; for saliva, sensitivity
ranging from 85 to 99 % and specificity from 99 to 100%.
2. Selection of the biological sample to be tested according to the investigated infectious
diseases
Investigated
infectious diseases
Number of test Recommended
biological sample *
HIV One test 1 DBS, Blood, saliva
Two tests Blood, DBS
HBV One test Blood, DBS 2
HCV One test DBS, blood, saliva
HIV and HBV HIV : one test Blood, DBS 2
, saliva
HIV : two tests Blood, DBS
HIV and HCV HIV : one test DBS, blood, saliva
HIV : two tests Blood, DBS
HBV and HCV One test Blood, DBS 2
HIV and HBV and
HCV
HIV : one test Blood, DBS 2
, saliva
HIV : two tests Blood, DBS 3


* in order of preference (accounting for sensitivity and specificity);
1
based on the prevalence of HIV in the population;
2
only HBsAg can be detected in DBS
Besides, nowadays in Europe, HIV, HBV and HCV tests have to meet quality
criteria specified in the European Common Technical Specifications


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List of new 2023 POCT IVD PCR NAT intruments

  1. Genmark Dx (14 targets)
  2. BD Max Influenza A/B
  3. Elitech InGenius Flu A/B & RSV

  4. Luminex Aries Flu A/B & RSV

  5. Luminex Verigene (16 targets)

  6. Biofire FilmArray (20 targets)

  7. Biocartis Idylla Inf A/B & RSV

  8. GeneXpert Xpress Flu A/B & RSV

  9. Cobas Liat

  10. Alere i
  11. TrueNAT Molbio

    12. Truelab® Quattro Real Time Quantitative micro PCR Analyzer

  12. Nanobiosym Precision

  13. IDnow Abbott
  14. EasyNAT Ustar
  15. MultNat Ustar 
  16. MiDiagnostics 11 min PCR
  17. Fluxergy 
  18. Sansure iPonatic® Ⅲ – Portable Molecular Workstation
  19.  Coyote FlashDetect™ Flash20

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