Supply, installation, service & maintenance of two genetic analyser ce systems (capillary electrophoresis) for nhls braamfontein

Division of Human Genetics uses of a Genetic Analyser for Sanger sequencing and fragment analyses. This instrument uses capillary electrophoresis to separate polymerase chain reaction (PCR) fragments of different lengths with high precision. In doing so, the laboratory is able to detect various point mutations, deletions and insertions which are causative of various genetic conditions. The laboratory can also use the instrument for the analysis of short tandem repeat polymorphisms which are useful in establishing relatedness, and chromosomal copy number variation inpatients. The current instrument can process 24 samples in parallel without affecting the running time of each sample, so that high-quality data can be used for high-throughput analysis. The division runs about 80% of its tests on the genetic analyser per year. The current instrument was an outright purchase and servicing the instrument is now via annual service contract deviations. . 4 MANDATORY REQUIREMENTS If a bidder does not comply fully with each of the mandatory requirements, it Shall be regarded as mandatory non-performance/non-compliance and the bid Shall be disqualified. No “unanswered” questions will be allowed. If a response to a question has been indicated as comply but not elaborated upon or substantiated it shall be regarded as mandatory non- performance/non-compliance and the bid shall be disqualified. Bidders shall provide full and accurate answers to the mandatory questions posed in this document, and, where required, explicitly state either “Comply/Accept (with a “Yes”)” or “Do not comply/do not accept (with a “No”)” regarding compliance to the requirements. Bidders must substantiate their responses to all mandatory questions. PLEASE NOTE: If the response does not substantiate any of the points or requirements in the body of the tender, it will be deemed to not comply, even if the ‘Comply’ field has been marked. Please note: All documentation to substantiate the mandatory requirements has to be supplied. TECHNICAL SUITABILITY: MANDATORY REQUIREMENTS (NOTE: The bidder who fails to comply with the Mandatory Requirements WILL be disqualified). Comply Do Not Comply

Capacity: must be able to run and complete 240 samples during an 8-hour period (i.e. 2 and half 96 well plates) with 24 samples per run. Substantiation: Provide proof by means of brochure/specification. Failure to provide information will lead to disqualification.

be capable of Sanger sequencing including Big Dye Terminator Chemistry. Comply Do Not Comply Substantiation: Provide proof by means of brochure/specifications. Failure to provide information will lead to disqualification.

be capable of Fragment analysis (Regular and HID, including STR’s, SNP’s, MLPA) Comply Do Not Comply with multiplexing and dosage detection capabilities, data collection and analysis. Substantiation: Provide proof by means of brochure/specifications. Failure to provide information will lead to disqualification.

be compatible with a minimum of 50cm capillary array. Comply Do Not Comply Confidential of 62 RFB208/25/26: Placement of 2 x Genetic Analysers CE (Capillary Electrophoresis) open system for Braamfontein-Genetic Department including reagents, service and maintenance for a period of five (5) years. Substantiation: Provide proof by means of brochure/specifications. Failure to provide information will lead to disqualification.

be capable of 6 dye chemistry. Comply Do Not Comply Substantiation: Provide proof by means of brochure/specifications/commitment letter. Failure to provide information will lead to disqualification.

be open system in terms of plasticware and kits that can be run on the equipment Comply Do Not Comply including, but not limited to: Applied Biosystems kits, custom fluorescently labelled primers, Promega kits, Yourgene kits, Asuragen kits, MRC Holland kits, Qiagen kits or equivalent (be able to add other suppliers’ kits as required) i.e. custom spectrals. Substantiation: Provide proof by means of brochure/specification/commitment letter. Failure to provide information will lead to disqualification.

Length required: Minimum 700bp for Sanger sequencing products and up to 1000bp Comply Do Not Comply for Fragment Analysis. 1000bp sizing is not required, but visualization of products is. Sizing for Fragment Analysis is required up to 600bp Substantiation: Provide proof by means of brochure/specification. Failure to provide information will lead to disqualification.

for analysis of DNA sequences as well as software for analysis of fragments. Comply Do Not Comply Analysis to include amplicon sizing, peak height, peak area, dye separation, to be able to load panels and bins for allele calling for kits from different suppliers for the duration of the contract. Substantiation: Provide proof by means of brochure/specification. Failure to provide information will lead to disqualification. Comply Do Not Comply

have automated amplicon separation with 1bp separation capability. Substantiation: Provide proof by means of brochure/specification or commitment letter. Failure to provide information will lead to disqualification.

have adjustable run conditions and protocols. Comply Do Not Comply Substantiation: Provide proof by means of brochure/specification. Failure to provide information will lead to disqualification. Comply Do Not Comply

must be capable of interfacing with LIMS/Third party softwares. Substantiation: Provide proof by means of brochure/specification/commitment letter. Failure to provide information will lead to disqualification.

have a Reagent usage tracking /notification. Comply Do Not Comply (Substantiation: Provide proof by means of brochure/specification/commitment letter. Failure to provide information will lead to disqualification.

be able to interface with Barcoding system. Comply Do Not Comply Substantiation: Provide proof by means of brochure/specification/commitment letter. Failure to provide information will lead to disqualification. Confidential of 62 RFB208/25/26: Placement of 2 x Genetic Analysers CE (Capillary Electrophoresis) open system for Braamfontein-Genetic Department including reagents, service and maintenance for a period of five (5) years.

be able to export data to an external device and data must retrievable and Comply Do Not Comply compatible to the lab PCs software (CSV, text files). Substantiation: Provide proof by means of brochure/specification/commitment letter. Failure to provide information will lead to disqualification.

Functionality 5.1The bidder must complete in full all of the TECHNICAL FUNCTIONALITY requirements. 5.2 The bidder must provide a unique reference number (e.g. binder/folio, chapter, section, page) to locate substantiating evidence in the bid response. During evaluation, NHLS reserves the right to treat substantiation evidence that cannot be located in the bid response as “NOT COMPLY”. Evaluation per requirement. The evaluation (scoring) of bidders’ responses to the requirements will be determined by the completeness, relevance and accuracy of substantiating evidence. Each TECHNICAL FUNCTIONALITY requirement will be evaluated using the following generic point scale: Technical Functionality Requirements The bidder must achieve a score of 75% to be eligible to proceed to the next stage of the evaluation. Substantiation: Evidence can be provided in the brochure and/ or manuals and /or commitment letters. Evaluation Criteria Score % Substantiate Reference The analysis software should be able to calculate paternity and other kinship 15% likelihood ratios. Analysis software to calculate paternity and other kinship likelihood ratios to be compatible with LAB workflow without the need for exporting data to other software = 15% Analysis software to calculate paternity and other kinship likelihood ratios to be compatible with LAB workflow with exporting data to third party software = 10% Software for calculating paternity and other kinship likelihood ratios not compatible with lab workflow/No software = 0% (Provide proof by means of specification/brochure). Instrument related Reagent Loading should be Plug and Play: 20% No manual intervention beyond loading a sachet = 20%. Pippeting of reagents onto the instrument = 15% Having to dilute/mix reagents prior to loading = 0% (Provide proof by means of specification/brochure). Confidential of 62 RFB208/25/26: Placement of 2 x Genetic Analysers CE (Capillary Electrophoresis) open system for Braamfontein-Genetic Department including reagents, service and maintenance for a period of five (5) years. Evaluation Criteria Score % Substantiate Reference Duration of maintenance. 15% Daily maintenance less than 5 minutes, Weekly and Monthly maintenance less than 1 hour = 15% Daily maintenance less than 5 minutes, Weekly and Monthly maintenance between 1-2 hours = 10% Daily maintenance up to 10 minutes, Weekly and Monthly maintenance up to 2 hours = 5% Daily maintenance more than 10 minutes, Weekly and Monthly maintenance more than 2 hours = 0% (Provide proof by means of specification/brochure). Spares/parts must be readily available. 15% Available in approximately 6 hours = 15% Available in approximately 24 hours = 10% Available in approximately 48 hours =5% (Provide proof by means of specification/brochure/ commitment letter). Back-up Network associated Storage device on-site for storing DNA data from 10% the instrument: Provide Back-up data storage of 32TB = 10% Provide Back-up data storage of 16TB = 5% No Back-up data storage provided = 0% (Provide proof by means of specification/brochure/ commitment letter). Nucleic Acid Sequencing alignment software: 15% Should be able to align unknown nucleic acid sequences with the reference sequence and identify mismatches/conflicts = 15% Not able to provide a Nucleic Acid Sequence alignment software = 0% Provide proof by means of specification/brochure/ commitment letter). Reagents usage management report: 10% Capable of providing a historical breakdown of reagent usage, with lot numbers and dates changed, as well as current and remaining usage = 10% Provide only current and remaining usage = 5% Provides no breakdown of current and remaining usage = 0% TOTAL 100% Confidential of 62 RFB208/25/26: Placement of 2 x Genetic Analysers CE (Capillary Electrophoresis) open system for Braamfontein-Genetic Department including reagents, service and maintenance for a period of five (5) years. Summary- The bidder needs to provide detailed brochure/ Specification confirming the above. The bid must achieve score of 75% as illustrated above to be eligible to proceed to the next stage of the evaluation.

threshold of 75% needs to be achieved to be considered for further evaluation.

bid specification was compiled and approved by the Line of Business and the following is hereby confirmed:

Bid Specification document can be objectively evaluated using the evaluation criteria stated in the RFB document; and

technical specifications are open and not written around a particular brand or product. Confidential of 62 RFB208/25/26: Placement of 2 x Genetic Analysers CE (Capillary Electrophoresis) open system for Braamfontein-Genetic Department including reagents, service and maintenance for a period of five (5) years.

specific requirements found