Initial sensitivity: 100% Final specificity: 98% Initial sensitivity: 99%

(1)

List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Since 1988, WHO has performed assessments of commercially available diagnostics for HIV, hepatitis B, and hepatitis C. Previously, this process was called the WHO Test Kit Evaluation programme, it was the predecessor of the WHO Prequalification of Diagnostics Programme. During this transition period, products that were previously evaluated by the WHO Test Kit Evaluation programme and found to meet the acceptance criteria will still be considered eligible for procurement. In the future, successful WHO prequalification will become the sole determinant of eligibility for procurement by WHO. Currently, products that meet either of the following criteria are eligible to participate in the WHO process for establishing a long term agreement (LTA) for procurement by WHO through a request for proposal (RFP).

1) Criteria for all types of assays (HIV, HCV, HBsAg serology, HIV virological, CD4 numeration technologies:

a) Meet all requirements for WHO prequalification by WHO Prequalification of Diagnostics programme, including dossier assessment, site inspection and laboratory evaluation according to the acceptance criteria below;

2) Interim criteria for HIV, HCV, HBsAg serology assays only that are not yet WHO prequalified:

a) acceptable results for laboratory evaluation in the WHO Test Kit Evaluation programme according to acceptance criteria below, and

b) have submitted an application to the WHO Prequalification of Diagnostics programme.

Laboratory evaluation acceptance criteria for serology assays:

Analyte EIAs Simple assays/rapid diagnostic tests

anti-HIV-1/2 and/or HIV-1 p24 Ag

Initial sensitivity: 100%

Final specificity: ≥ 98%

Initial sensitivity: ≥ 99%

Final specificity: ≥ 98%

Inter-reader variability: ≤5%

Invalid rate: ≤5%

anti-HCV Initial sensitivity: 100%

Final specificity: ≥ 98%

Initial sensitivity: ≥ 98%

Final specificity: ≥ 97%

Inter-reader variability: ≤5%

Invalid rate: ≤5%

HBsAg Initial sensitivity: 100%

Final specificity: ≥ 98%

Initial sensitivity: 100%

Final specificity: ≥ 98%

Inter-reader variability: ≤5%

Invalid rate: ≤5%

Ineligibility for procurement

Products may be ineligible for procurement by WHO if made obsolete by their manufacturer, if de-listed from the list of WHO prequalified products, if Field Safety Notice or Notice of Concern is active.

See web address for reports containing WHO Test Kit Evaluation programme data at

http://www.who.int/diagnostics_laboratory/publications/evaluations/en/index.html

See web address for WHO Prequalification of Diagnostics Public Reports at

http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/index.html

See web address for outstanding Notice of Concerns and Field Safety Notices at

http://www.who.int/diagnostics_laboratory/procurement/complaints/en/

Shelf life

Shelf life upon manufacture is stated by the manufacturer at the time of WHO prequalification, and

supported by evidence in the product dossier. Guaranteed minimum shelf life upon delivery is likely to

be less and should be negotiated as part of the bidding process. For this list, shelf life upon manufacture

(2)

List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Manufacturer Assay name (Country of manufacture)

Product code No. of tests per kit

Initial sensitivity

Final specificity

Shelf life/

storage temp

Analyte Specimen type

Comments WHO PQDx status

(PQ Public Report)

HIV Simple Assays/Rapid Diagnostic Tests (RDTs)

ABON™ HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/

Serum/Plasma

ABON Biopharm (Hangzhou) CO., LTD

(Hangzhou, PR China)

IHI-T402W

⁴⁰ ^100% ^99.7% 24 months/

2 to 30°C

Discrimination between HIV-1 and HIV-2 antibodies

Serum, plasma, whole

blood

If whole blood: lancets, alcohol swabs, and heparinized capillary tubes with 50 µL mark line and dispensing bulb.

http://www.who.int/diagnost ics_laboratory/evaluations/1 40924_public_report_abon_h iv_triline_rdt_v2.0.pdf?ua=1

Alere Medical Co. Ltd.

Alere Determine™ HIV-1/2 (Matsudo, Japan)

7D2342 7D2343

20 100

100% 99.4% 14 months/

2 to 30°C

HIV-1/2 antibodies combined

blood

If whole blood: lancets, alcohol swabs, chase buffer (7D2211), EDTA capillary tubes (7D2222).

If serum/plasma: requires precision pipette plus tips.

http://www.who.int/diagnost ics_laboratory/evaluations/1 11125_0033_013_00_public_

report_final.pdf

Alere Medical Co. Ltd.

Alere Determine™ HIV-1/2 Ag/Ab Combo

(Matsudo, Japan)

7D2643 100 100% 98.8% 10 months/

2 to 30°C

Discrimination between

HIV-1/2 antibodies combined and

HIV-1 p24 antigen

blood

If whole blood: lancets, alcohol swabs, chase buffer (7D2211),EDTA capillary tubes (7D2222).

http://www.who.int/diagnost ics_laboratory/evaluations/1 20320_0034_013_00_final_p ublic_report_version2.pdf

bioLytical™ Laboratories

Insti HIV-1/HIV-2 Antibody Rapid Test

(Richmond, Canada)

90-1012 90-1013 90-1010 90-1022 90-1021

1 24 24 48 48

100% 99.7% 15 months/

15 to 30°C

blood

If 90-1010, 90-1021: lancets, alcohol swabs, precision pipette plus tips.

http://www.who.int/diagnost ics_laboratory/evaluations/1 30829_0002-002-

00_public_report_final_v1.pd f

bioMérieux VIKIA HIV 1/2

(Marcy l'Etoile, France)

311112 25 99.4% 99.9% 21 months/

4 to 30°C

blood

If whole blood: lancets, alcohol swabs.

report_final_v1.pdf

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Initial sensitivity

Final specificity

Shelf life/

storage temp

(PQ Public Report)

Chembio Diagnostic Systems, Inc.

HIV 1/2 STAT-PAK®

(Medford, USA)

HIV101 20 99.3% 100% 24 months/

8 to 30°C

blood

HIV Test Kit Controls (HIV104) available.

report_final_v1.pdf

Chembio Diagnostic Systems, Inc.

HIV 1/2 STAT-PAK® Dipstick (Medford, USA)

HIV303 30 100% 99.7% 24 months/

8 to 30°C

blood

If alternate procedure: must order sample tubes and tube rack.

report_final.pdf

OraSure Technologies Inc.

OraQuick® HIV-1/2 Rapid Antibody Test

(Bangkok, Thailand)

5X4-0010 5X4-0012

100 500

100% 99.2% 8 months/

2 to 30°C

blood, oral fluid

If whole blood: lancets, alcohol swabs, additional specimen loops (004-001).

In progress

Orgenics Ltd.

Immunocomb® II HIV 1&2 BiSpot (Yavne, Israel)

6042002 36 100% 99.4% 15 months/

2 to 8°C

Serum, plasma

Not suitable for whole blood Requires precision pipette plus tips.

http://www.who.int/diagnost ics_laboratory/evaluations/1 40929_public_report_immun ocomb_hiv_bispot_v2.pdf?ua

=1

Premier Medical Corporation Ltd.

First Response™ HIV 1-2-0 Card Test

(Daman, India)

I05FRC30 30 100% 98.8% 23 months/

4 to 30°C

blood

In progress

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Version 15, 7 October 2014 - This list supersedes all previous lists. Page 4 of 13

Initial sensitivity

Final specificity

Shelf life/

storage temp

(PQ Public Report)

Shanghai Kehua Bioengineering Co. Ltd.

Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) (Shanghai, PR China)

KH-R-02 50 100% 100% 15 months/

4 to 30°C

HIV-1/2 antibodies combined detection

blood

Requires precision pipette plus tips.

In progress

Standard Diagnostics, Inc.

SD BIOLINE HIV-1/2 3.0 (Yongin-si, Korea)

03FK16 03FK10

25 30

99.8% 99.9% 24 months/

1 to 30°C

blood

If 03FK10: lancets, capillary pipettes, alcohol swabs.

http://www.who.int/diagn ostics_laboratory/evaluati ons/130528_0027_012_00 _public_report_final_v2.p df

Standard Diagnostics, Inc.

SD BIOLINE HIV Ag/Ab Combo (Yongin-si, Korea)

03FK35 03FK30

25 30

100% 99.1% 18 months/

1 to 30°C

HIV-1 p24 antigen

blood

If 03FK30: lancets, capillary pipettes, alcohol swabs.

report_final_v1.pdf

Trinity Biotech Manufacturing Ltd.

Uni-Gold™ HIV (Bray, Ireland)

1206502 1206502N 1206502E

20 99.8% 99.9% 12 months/

2 to 27°C

HIV-1/2 antibodies combined detection

blood

00_public_report_v1.pdf

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Initial sensitivity

Final specificity

Shelf life/

storage temp

Analyte Wavelength Comments WHO PQDx status

(PQ Public Report)

HIV Enzyme Immunoassays (EIAs)

Bio-Rad

Genscreen™ ULTRA HIV Ag-Ab ( Steenvoorde, France)

72386 72388

96 480

100% 99.2% 18 months/

2 to 8°C

HIV-1 p24 antigen

450/

620 -700 nm

Not suitable for whole blood Requires EIA incubator, washer, reader, precision pipette plus tips, deionised water.

00_public_report_final_v1.pd f

Format HIV Supplemental Assays

Fujirebio Europe N.V.

INNO-LIA

^TM

HIV I/II SCORE (Ghent, Belgium)

80540 20 N/A N/A 12 months/

2 to 8°C

line immunoassay / recombinant

proteins, synthetic peptides

Not suitable for whole blood Requires precision pipette plus tips and other consumables.

In progress

MP Biomedicals Asia Pacific Pte.

Ltd.

HIV BLOT 2.2

(Singapore, Singapore)

11030-036 36 N/A N/A 11 months/

2 to 8°C

Western blot/

viral lysate, synthetic

peptide

Not suitable for whole blood Requires precision pipette plus tips and other consumables.

In progress

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Initial sensitivity

Final specificity

Shelf life/

storage temp

Analyte Specimen type Comments WHO PQDx status

(PQ Public Report)

HCV Rapid Diagnostic Tests (RDTs)

N/A

Wavelength HCV Enzyme Immunoassays (EIAs)

Fujirebio Europe N.V.

INNOTEST HCV Ab IV (Ghent, Belgium)

80068 80330

192 480

100% 100% 10 months/

2 to 8°C

HCV antibodies

450/620nm Not suitable for whole blood Requires EIA incubator, washer, reader, precision pipette plus tips, deionised water.

In progress

Format HCV Supplemental Assays

Fujirebio Europe N.V.

INNO-LIA HCV Score (Ghent, Belgium)

80538 20 N/A N/A 10 months/

2 to 8°C

HCV antibodies

Line immunoassay/

synthetic peptides

Not suitable for whole blood Requires incubator, aspirator/vacuum, precision pipette plus tips and other consumables.

In progress

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Initial sensitivity

Final specificity

Shelf life/

storage temp

(PQ Public Report)

HBsAg Rapid Diagnostic Tests (RDTs)

Alere Medical Co. Ltd.

Alere Determine

^TM

HBsAg (Matsudo, Japan)

7D2513

100 99.0% 99.4% 12 months/

2 to 30°C

HBV surface antigen

blood

If whole blood: lancets, alcohol swabs, chase buffer (7D2211), EDTA capillary tubes (7D2222).

In progress

Wavelength HBsAg Enzyme Immunoassays (EIAs)

DiaSorin S.p.A UK Branch Murex HBsAg Version 3 Confirmatory Reagents (Dartford, UK)

9F80-01 9F80-05 2G27-01

96 480

50

100% 98.3% 12 months/

2 to 8°C

HBV surface antigen

450/

620 - 690

Not suitable for whole blood Requires EIA incubator, washer, reader, precision pipette plus tips, deionised water, 2M sulphric acid.

In progress

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Shelf life/

storage temp

Specimen type Comments WHO PQDx status (PQ Public Report)

CD4 Enumeration Technologies

Alere Technologies GmbH Pima CD4 Test

(Jena, Germany)

260300001 (instrument) 260100100 (test kit)

N/A 100

12 months

(reagent) / 2 to 30°C

Venous and capillary whole

blood

Accessories available. http://www.who.int/diagn ostics_laboratory/evaluati ons/111208_0099_032_00 _public_report_v2.pdf

Becton, Dickinson and Company, BD Biosciences BD FACSCount™ Instrument System with FACSCount™

Control Kit and BD FACSCount™ Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts)

(San Jose, USA)

337858 (instrument) 340167 (test kit) 340166 (control kit)

N/A 50 25

23 months (reagent), 24 months (control) /

2 to 8°C

Venous whole blood

N/A http://www.who.int/diagn

ostics_laboratory/evaluati ons/121115_0124_045_00 _public_report_v2_final.p df

Becton, Dickinson and Company, BD Biosciences BD FACSCountTM Instrument System with FACSCountTM Control Kit and BD

FACSCountTM CD4 Reagent Kit (Absolute and

Percentage CD4+ Counts) (San Jose, USA)

337858 (instrument) 339010 (test kit) 340166 (control kit)

N/A 50 25

15 months (reagent), 24 months (control) / 2 to 8°C

Venous whole blood

N/A http://www.who.int/diagn

ostics_laboratory/evaluati ons/121115_0133_045_00 _public_report_v1_final.p df

Becton, Dickinson and Company, BD Biosciences BD FACSPresto™ Near Patient CD4 system

651000 (instrument) 657681 (cartridge) 655495 (cartridge kit)

N/A 100 100

12 months /4-31 °C

Venous and capillary whole

blood

BD FACSPresto™ work Station and

accessories also available

http://www.who.int/diagn ostics_laboratory/evaluati ons/140918_public_report _bdfacspresto_cd4.pdf?ua

=1

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Manufacturer Assay name

Assay Name, Specific Consumables and Product codes Number of Tests per kit

Storage temp

Shelf- life

Specimen Type

(PQ Public Report)

HIV Viral Load Technologies

Abbott

Molecular Abbott RealTime HIV-1 (Des Plaines, USA)

Abbott RealTime HIV-1 (Assay)

Extraction reagents: mSample Preparation System RNA (4 X 24 Preps) 04J70-24

Amplification Reagents: Abbott RealTime HIV-1 2G31:

2G31-90 (Abbott RealTime HIV-1 Amplication Reagent kit), 2G31-80 (Abbott RealTime HIV-1 Control kit),

2G31-70 (Abbott RealTime HIV-1 Calibrator kit)

4 X 24 Preps

96T/kit 8 runs 4 runs

15 to 30°C

-10°C -10°C -10°C

18 months

Plasma

Required for all configurations For a full list of consumables required, see Public reports

For the Manual configuration see:

http://www.who.int/diag nostics_laboratory/evalu ations/120113_0146_027 _00_final_public_report_

v2.pdf

For the m2000sp configuration see:

v2.pdf For the m24sp configuration see:

v2.pdf

Abbott m2000sp Instrument 9K14-02 Required for m2000sp only

Abbott m2000rt Instrument 9K15-01 Required for all configurations

Abbott m24sp Instrument 3N06-01 Required for m24sp only

Abbott m2000rt Optical Calibration kit 4J71-93 Required for all configurations

Software: Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or higher

Required for all configurations

Optional: Abbott RealTime HIV-1 UNG Protocol 2G31-66 Optional for all configurations

5 mL Reaction Vessels 4J7120 Required for all configurations

96-Well Optical Reaction Plates 4J7170 Required for all configurations

Optical Adhesive Covers 4J7175 Required for all configurations

Adhesive Cover Applicator 9K3201 Required for all configurations

Splash-Free Support Base 9K3101 Required for all configurations

1.5 mL Screw Top Microfuge Tubes and Caps 4J7150 Required for manual and m24sp

Disposable Tips (DiTis), 1000 µL 4J7110 Required for m2000sp and m24sp

Disposable Tips (DiTis), 200 µL 4J7117 Required for m2000sp and m24sp

Biohazard Bags 4J7145 Required for m2000sp and m24sp

200 ml Reagent Vessels 4J7160 Required for m2000sp and m24sp

96 Deep Well Plates 4J7130 Required for m2000sp and m24sp

13 mm Sample Racks 4J7282 Required for m2000sp and m24sp

m2000 mSample Preparation System Start Up Kit: Eppendorf Cooler & 2 Required for m2000sp and m24sp

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Assay Name, Specific Consumables and Product codes

Number of Tests per kit

Storage temp

Shelf-life (months)

Specimen Type

(PQ Public Report)

bioMérieux NucliSENS EasyQ® HIV- 1 v2.0 (Marcy L’Etoile, France)

NucliSENS Easy Q HIV-1 V2.0 285033

48T/kit 2 to 8°C

18

Plasma, dried blood spot (venous whole blood)

Required for automated only For a full list of

consumables required, see WHO Public Reports

For the automated configuration see:

http://www.who.int/

diagnostics_laborato ry/evaluations/1201 09_0127_016_00_pu blic_report_v1.pdf For the semi- automated configuration see:

http://www.who.int/

diagnostics_laborato ry/evaluations/1201 09_0148_016_00_pu blic_report_v1.pdf NucliSENS easyMAG configuration

4700014

Instrument required for automated only

NucliSENS easyMAG extraction Buffer 1

280130 4x1L 2 to 30°C 24 Required for automated only

NucliSENS Magnetic Extraction Reagent

200293 48T/kit 2 to 8°C 18 Required for semi-automated only

NucliSENS Lysis Buffer (2ml) 200292 48T/kit 2 to 30°C 24 Required for semi-automated only NucliSENS easyMAG extraction Lysis

Buffer 280134 4x1L 2 to 30°C 24 Required for automated only

NucliSENS easyMAG magnetic silica

NucliSENS miniMAG configuration 4700015

Instrument required for semi-automated only

NucliSENS Easy Q configuration 4700016 Instrument required for both configurations (automated and semi-

automated)

Mini Strip Centrifuge 285056 Required for both configurations (automated and semi-automated)

Promega Magnetic Rack 12 holes 200299 Required for semi-automated only

Micro Tubes 1.5 ml with caps 200294 Required for semi-automated only

Biohit Tips 280146 Required for automated only

EasyMAG disposables 280135 Required for both configurations (automated and semi-automated)

Strip Plates Greiner 278303 Required for automated only

EasyQ 8-Tube Caps 285051 Required for both configurations (automated and semi-automated)

EasyQ 8-Tube Strips 285048 Required for both configurations (automated and semi-automated)

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List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Number of Tests per kit

Storage temp

Shelf-life (months)

Specimen type

(PQ Public Report)

Roche Molecular Systems COBAS®

AmpliPrep/

COBAS®

TaqMan HIV-1 Test version 2.0 (Branchburg , USA)

COBAS® AmpliPrep/ COBAS® TaqMan HIV-1 Test version 2.0:

COBAS® AmpliPrep/ COBAS® TaqMan HIV-1 Test version 2.0, 05212294190

COBAS AmpliPrep/COBAS TaqMan Wash Reagent 03587797190

48T/kit

5.1L

2 to 8°C

2 to 30°C

18

24

Plasma

For a full list of consumables required, see WHO Public Reports

For the TaqMan 96 configuration see:

http://www.who.int/diagnos tics_laboratory/evaluations/

120502_0147_046_00_publi c_report_v1_final.pdf

For the TaqMan 48 configuration see:

http://www.who.int/diagnos tics_laboratory/evaluations/

120502_0126_046_00_publi c_report_v1_final.pdf

COBAS® TaqMan® 48 Analyzer 03279332001 Instrument required for TaqMan 48 only

COBAS® Ampliprep Instrument 03051315001 Required for all configurations

COBAS® TaqMan® Analyzer 03121453001 Required for TaqMan 96 only

AMPLILINK Software, Version 3.2 Series 04862392001 or

AMPLILINK Software, Version 3.3 Series

05807875001 Required for all configurations

cobas p 630 instrument 05527503001 Optional Instrument

Docking Station 28127387001 Optional Instrument

Sample processing units: SPUs 03755525001 Required for all configurations

Sample input tubes (S-tubes) with barcode clips

03137040001 Required for all configurations

Racks of K-tips 03287343001 Required for all configurations

K-tube Box of 12 x 96 03137082001 Required for all configurations

Sample Rack (SK 24 rack) 028122172001 Required for all configurations

Reagent Rack 028122199001 Required for all configurations

SPU rack 05471664001 Required for all configurations

K-tube capper, motorized 03516539001 Required for all configurations

K-tube capper 03339874001 Required for all configurations

K-carrier 03341488001 Required for all configurations

K-carrier Transporter 03517519001 Required for all configurations

K-carrier rack 03286436001 Required for all configurations

(12)

List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Numb er of Tests per kit

Storage temp

Shelf-life (months)

Specimen type Comments WHO PQDx status

(PQ Public Report)

Siemens Healthcare Diagnostics VERSANT®

HIV-1 RNA 1.0 Assay (kPCR) (Tarrytown, USA)

VERSANT kPCR Molecular System 10467524 (Instrument

Plasma Required for all configurations For a full list of consumables required,

see WHO Public Reports

http://www.who.int/diagnostics_labora tory/evaluations/120213_0115_041_00 _public_report_final_v1.pdf

VERSANT Sample Preparation 1.0 Reagents, IVDD

(Box 1), 04801677 96T/kit 15 to 30°C 24

VERSANT Sample Preparation 1.0 Reagents, IVDD

(Box 2), 04801685 96T/kit 2 to 8°C 24

VERSANT HIV-1 RNA Assay 1.0 (kPCR), IVDD (Box

1), 10375763 96T/kit

-30 to -

10°C 12

VERSANT HIV-1 RNA Assay 1.0 (kPCR) IVDD (Box 2),

10375764 96T/kit

-90 to -

60°C 12 Required for all configurations

Large reagent troughs and small reagent troughs, 10489008

1000-μL pipette tips, 06635759 Required for all configurations

300-μL pipette tips, 06635767 Required for all configurations

96-well, 2-mL nuclease free, sterile deep well plates, 06691055

Barcoded 96-well semi-skirted polypropylene plates for PCR 06653412

Optical caps, 8x strip, 06653439 Required for all configurations

(13)

List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics)

Assay Name, Specific Consumables and Product codes Number of Tests per kit

Storage temp Shelf-life (months)

Specimen Type

(PQ Public Report)

HIV Virological Technologies for HIV diagnosis, including early infant diagnosis

Abbott

Molecular Abbott RealTime HIV-1 Qualitative (Des Plaines, USA)

Abbott RealTime HIV-1 Qualitative:

Abbott mSample Preparation SystemDNA 6K12-24 Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90

Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80

4 X 24 Preps 96T/kit 8 runs

15 to 30°C -10°C -10°C

18

Plasma, dried blood

spot

Required for all configurations For a full list of consumables required, see WHO Public Reports:

For the automated configuration see:

http://www.who.int/diagno stics_laboratory/evaluations /130530_0084_027_00_pub lic_report_final.pdf

For the Manual configuration see:

http://www.who.int/diagno stics_laboratory/evaluations /130530_0151_027_00_pub lic_report_final.pdf

Abbott m2000sp Instrument 9K14-02 Required for m2000sp only

Abbott m2000rt Instrument 9K15-01 Required for all configurations

Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher

Software required for all configurations

Abbott RealTime HIV-1 UNG Protocol 4N66-66 -15 to -25°C. Optional with all configurations

Abbott m2000rt Optical Calibration kit 4J71-93 Required for all configurations

5 mL Reaction Vessels (List No. 4J71-20) Required for all configurations

Calibrated Pipettes capable of delivering 20‑1000 μL Required for all configurations

Aerosol Barrier Pipette Tips for 20-1000 μL Pipettes Required for all configurations

1000 μL Disposable Tips (List No. 4J71-10) Required for all configurations

200 μL Disposable Tips (List No. 4J71-17) Required for all configurations

Vortex Mixer Required for all configurations

USP Grade 190-200 Proof Ethanol (95%-100% Ethanol). Required for all configurations

Abbott Optical Adhesive Covers (List No. 4J71-75) Required for all configurations

Abbott Adhesive Cover Applicator (List No. 9K32-01) Required for all configurations

Abbott Splash-Free Support Base (List No. 9K31-01) Required for all configurations

Master Mix Tube (List No. 4J71-80) Required for all configurations

13 mm Sample Racks (List No. 4J72-82) Required for all configurations

200 mL Reagent Vessels (List No. 4J71-60) Required for all configurations

Abbott 96-Deep-Well Plate (List No. 4J71-30) Required for all configurations

Abbott 96-Well Optical Reaction Plate (List No. 4J71-70) Required for all configurations

Centrifuge capable of 2000g Required for all configurations