The NHLS HTA Unit List of Prequalified IVD Products Year Type of evaluation Project Number IVD Technology Name Supplier Manufacturer 2014 Instrument Upgrade 2014 Instrument Upgrade HTP12-0045 Liason XL Humor Diagnostica Diasorin HTP14-19 Leica ASP6025 SMM Instruments (Pty )LTD Leica Biosystems *2015 New Instrument HTP12-0060 C Maglumi 2000: FSH, PCT, Cortisol, Ferritin The Scientific Group Snibe Diagnostic *2015 New Instrument HTP15-02 The Clinitek advantus Siemens Pty (LTD) Siemens Pty (LTD) Inc. 2015 New Instrument HTP13-06 The BioPlex 2200 Bio_rad South Africa Bio_rad Laboratories inc 2015 New Instrument HTP13-47 Easy G26 Separation Scientific SA (Pty )LTD Interlab 2015 New Instrument HTP13-29 Benchmark Special Stainer: ABPAS, AB, Fungi, FE, Jones, AFB, PAS, DPAS, Trichome, CR, Giemsa Roche Products PTY(LTD) Ventana Medical Systems, inc 2015 New Instrument HTP12-0016 RP500 (Blood gas) Siemens Pty (LTD) Siemens Pty (LTD) 2015 New Instrument HTP13-48B Capillarys 2 Flex Piercing (Serum as well as Urine protein electrophoresis) Ilex SA (PTY)Ltd 2015 New Instrument HTP13-35 CINtec PLUS (on the Benchmark XT system). Roche Products (PTY)Ltd Ventana Medical Systems, inc Sebia 2014 New Instrument HTP12-0019A Euroblaster Euroimmune Euroimmune 2014 New Instrument HTP12-0058 Swing and Saxo ID reader Biorad Biorad 2014 New Instrument HTP13-02 Microbiology automated systems Siemens Pty (LTD) Siemens The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 1 of 6
2014 New Instrument HTP13-23 Bond III SMM Instruments (PTY)Ltd Leica Biosystems 2014 New Instrument HTP13-26 Aptima HPV Ilex SA Hologic Gen probe 2014 New Instrument HTP13-31A Thinprep T2000 Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-34 COBAS 4800 HPV test (on the Benchmark XT system). Roche Products (Pty )LTD Roche Diagnostics 2014 New Instrument HTP13-36 Real time m2000 system HPV Abbott Laboratories (Pty )LTD Abbott Laboratories 2014 New Instrument HTP13-38 Xpert HPV assay for use with the GeneXpert system Cepheid Cepheid 2014 New Instrument HTP13-39 Digene HC2 High risk HPV DNA test Whitehead Scientific Qiagen Gaithersburg 2014 New Instrument HTP13-44 Biovue Technology The Scientific Group Ortho Clinical Diagnostics 2014 New Instrument HTP13-48 Capillarys 2 Flex Piercing Ilex SA Sebia 2014 New Instrument HTP13-31B Compass staining machine Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-31C Thinprep T5000 Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-31D Thinprep Imaging System and I-square Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-31E Thinprep T-5 Autoloader S Separation Scientific SA (Pty )LTD Hologic Gen probe 2013 New Instrument HTP12-0022 SG Vacutainer tubes The Scientific Group The Scientific Group 2013 New Instrument HTP12-0027 ACL TOP 300/ 500 Beckman Coulter Instrumentation 2aboratory (Part of Werfen Group 2013 New Instrument HTP12-0029 EASY RA Medical Electronic Distributors (Pty) LTD, (M.E.D) Medica The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 2 of 6
2013 New Instrument HTP12-0040 Stratus Siemens Pty (LTD) Siemens 2013 New Instrument HTP12-0046 Sysmex 500i Roche Products (Pty )LTD Sysmex 2013 New Instrument HTP12-0055 Symex XN 2000 Roche Products (Pty )LTD Sysmex 2013 New Instrument HTP13-12 iq 200 System Beckman Coulter Iris International 2013 New Instrument HTP13-15 Architect c4000 Abbott Laboratories Copan Italia S.p.A 2013 New Instrument HTP13-32A Therascreen RGQ mutation assays Kras Whitehead Scientific QiaGen N.V. 2013 New Instrument HTP13-32B Therascreen RGQ mutation assays Braf Whitehead Scientific QiaGen N.V. 2012 New Instrument HTP12-0013 Mindray BC-5800 Separation Scientific SA (Pty )LTD Mindray 2012 New Instrument HTP12-0031 Tosoh G8 HBA1c Replamed Tosoh Bioscience 2012 New Instrument HTP12-0056 Sysmex 2100 XI Roche Products (Pty )LTD Sysmex 2012 New Instrument HTP12-0057 BactAlert FA Plus Biomerieux South Africa Biomerieux 2015 Reagent Upgrade HTP15-27 Estradiol Roche Products (Pty )LTD Roche Diagnostics GmbH 2015 Reagent Upgrade HTP14-18 Tina Quant Lipoprotein Gen.2 Roche Products (Pty )LTD Roche Diagnostics GmbH 2015 Reagent Upgrade HTP15-15 Advia 1800 concentrated ALB, CRE, AST, ALT, Phos Siemens Pty (LTD) Siemens Pty (LTD) Inc 2015 Reagent Upgrade HTP14-36 BILT Gen 3 on C111 Roche Products (Pty )LTD Roche Diagnostics GmbH 2015 Reagent Upgrade HTP14-40 Vitamin D Total Roche Products (Pty )LTD Roche Diagnostics GmbH The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 3 of 6
2014 Reagent Upgrade HTP13-40 Free T4 Assay on Architect Abbott Laboratories (Pty )LTD Abbott Laboratories 2014 Reagent Upgrade HTP13-41 Anti HCV Architect Abbott Laboratories (Pty )LTD Abbott Laboratories 2014 Reagent Upgrade HTP14-01 Tina Quant HBA1c Roche Products (Pty )LTD Roche Diagnostics 2014 Reagent Upgrade HTP14-14 Access AccuTnI+3 assay Beckman Coulter Beckman Coulter 2014 Reagent Upgrade HTP14-15 Access Total BHcG (5 th IS) Beckman Coulter Beckman Coulter 2013 Reagent Upgrade HTP12-0047 Calcium GEN2 reagent Roche Products (Pty )LTD Roche Diagnostics 2013 Reagent Upgrade HTP12-0059 Calcium reagent Roche Products (Pty )LTD Roche Diagnostics 2013 Reagent Upgrade HTP13-10 Tropinin I Siemens Pty (LTD) Siemens 2013 Reagent Upgrade HTP13-27 ALPi reagent and ALPi Calibrator Siemens Pty (LTD) Siemens Pty (LTD) 2012 Reagent Upgrade HTP12-0028 ALTI reagent Siemens Pty (LTD) Siemens Pty (LTD) *2015 New reagent HTP15-16 ADVIA Centaur Cortisol assay Siemens Pty (LTD) Siemens Pty (LTD) Products GmbH *2015 New reagent HTP14-17 Syphillis Total Ab Roche Products PTY(LTD) Roche Diagnostics 2015 New reagent HTP13-28 Vitek 2 Biomerieux South Africa Biomerieux 2015 New Reagent HTP13-51 Alpha-Tec System-MTB Decontamination/ Digestion systems Cepheid Alpha-Tec Systems Inc. 2014 New Reagent HTP12-0019B Euroline Allergy strips Euroimmune Euroimmune 2014 New Reagent HTP13-09 RBC FOLATE reagent on Cobas e611 Roche Products (Pty )LTD Roche Diagnostics The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 4 of 6
2014 New Reagent HTP13-30 CMV ON Cobas Ampliprep/ Taqman Roche Products (Pty )LTD Roche Diagnostics 2014 New Reagent HTP14-25 Real time m2000 system CMV Abbott Laboratories (Pty )LTD Abbott Laboratories 2013 New Reagent HTP12-0052 HIV LFC Atomo Diagnostics Atomo Diagnostics 2013 New Reagent HTP12-0062 CI8200 HBA1C Abbott Laboratories (Pty )LTD Abbott Laboratories *2015 POCT Instrument HTP14-21 BD FACSPresto The Scientific Group BD Biosciences 2015 POCT Instrument HTP13-04 Afinion: Lipid panel Alere Healthcare Axis Shield 2015 POCT Instrument HTP15-19 TOX/See Rapid Urine Drug Screen Tests Bio-Rad Laboratories (Pty )LTD Biorad Laboratories, Inc 2013 POCT Instrument HTP12-0035 AQT90 Radiometer Radiometer 2013 POCT Instrument HTP12-0037 Genius HIV Biorad Beckman Coulter 2013 POCT Instrument HTP12-0053 Afinion: HBA1c Alere Healthcare Axis Shield 2012 POCT Instrument HTP12-0034 Triage : D-Dimer Test Alere Healthcare Alere Healthcare 2014 POCT RDT HTP14-31 Biotracer HIV1/2 Rapid card Fulloutput1305 cc Bio Focus Co., Ltd. 2014 POCT RDT HTP14-28 HIV 1,2 RDT Clinihealth International Cork Technology 2014 POCT RDT HTP14-09 RightSign HIV 1.2 O Rapid test cassette NH Medicals Hangzhou Biotest Biotech, Co.Ltd 2013 POCT RDT HTP12-0004 Parahit f Ver 1.0 - Device & Parahit Total Ver 1.0 - Device. Span Diagnostics Ltd Span Diagnostics Ltd 2013 POCT RDT HTP12-0032 Cryptococcus LFC Hain Lifescience Immuno-Mycologics Inc (Immy) The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 5 of 6
2012 POCT RDT HTP12-0001 RPR Chromatest Span Diagnostics Ltd Span Diagnostics Ltd 2012 POCT RDT HTP12-0002 Signal HIV Span Diagnostics Ltd Haemotec 2012 POCT RDT HTP12-0008 Blood Grouping antisera Span Diagnostics Ltd Span Diagnostics Ltd 2012 POCT RDT HTP12-0039 OneStep Anti-Syphilis Cassette Test Humor Diagnostica Cortez Diagnostics The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 6 of 6