Rfb069/25/26 - Outright Purchase of a Digital Polymerase Chain Reaction (pcr)...

Returnable Documents:

Digital PCR builds on traditional PCR amplification and fluorescent-probe-based detection methods to provide highly sensitive absolute quantification of nucleic acids without the need for standard curves. The Somatic Cell Genetics Unit (SCGU) requires a digital PCR system to ensure that high quality and consistent results are produced, thereby ensuring the patient is receiving an accurate quantitative account of the levels of measurable residual disease still detectable. This will ensure that the correct treatment or therapy is provided to the patients. Since one of the limitations of real-time PCR is that it estimates the amount of amplified PCR product at the end of several PCR cycles, it is thus a semi-quantitative method. However, in digital PCR the sample is portioned into thousands of microchambers, or reaction vessels, and the number of target molecules is measured directly by counting positive fluorescence in the microchambers. This is a more accurate method and provides an absolute quantitative measurement. Confidential of 62 RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital. 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 4. TECHNICAL SUITABILITY: MANDATORY REQUIREMENTS (Note: The bidder who fails to comply with the Mandatory Requirement WILL be disqualified). 1. Validation reagents and consumables must be at the cost of the supplier. Placement Comply Do Not certificate required on installation of instruments. Comply Substantiate: The bidder must provide a letter of commitment. Failure to provide the information will lead to disqualification. 2. The bidders should be able to provide a benchtop stand-alone Comply Do Not Comply system. Substantiation: The bidder must provide a letter of commitment. Failure to provide the information will lead to disqualification. Comply Do Not Comply 3. Sequence specific hydrolysis probes (FAM, HEX, or TAMRA) preferable with more than two optical channels. Substantiation: The bidder must provide proof by means of brochure/ specification. Failure to provide the information will lead to disqualification. 4. The bidders must be able to supply all required reagents and Comply Do Not Comply consumables for the tests including reagents including polymerase, reverse transcriptase and plastic ware, quantification kits and plastic ware, any barcoded reagents, in- house primers and probes and cDNA reagents. Please refer to p.35 for volume estimates. Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 5. System needs to be compatible with both RNA and DNA as Comply Do Not Comply input material Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 6. Bidders to deliver, install and commission the platforms and Comply Do Not Comply provide a post-installation validation certificate. Installation should include any calibration and calibration kits required at the cost of the supplier. Confidential of 62 RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital. Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 7. The suppliers should be able to provide a 5-year service / Comply Do Not Comply maintenance plan which includes a 2-year warranty. Any replacement parts must be included in the service and maintenance contract. Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 8. Flexible customization of protocols; uploading of protocols and Comply Do Not Comply downloading and exporting of results; edit samples; monitor the run in progress; annotating and editing of ‘plate’ layouts before a run; perform self-test (clean and check); user friendly operating systems. Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 9. Precision ~10%; low (~5%) dead volume; mutation detection to Comply Do Not Comply levels lower than 0.0001% Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 10. Optimized workflow to allow minimum hands-on time. Comply Do Not Comply Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. 11. IS conversion kit for BCR::ABL1 IS% validation, compatible with GUSB Comply Do Not Comply Substantiation: The bidder must provide proof by means of brochure/specification Failure to provide the information will lead to disqualification. Confidential of 62 RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital. ANNEXURE B: Pricing Schedule Please indicate your total bid price here: R___________________________(inclusive of all applicable taxes, e.g. VAT) Important: It is mandatory to indicate your total bid price as requested above. This price must be the same as the total bid price you submit in your pricing schedule. Should the total bid prices differ, the total bid price indicated above shall be considered the correct price. The following must be noted: 1. All prices must be VAT inclusive of all applicable taxes and must be quoted in South African Rand (ZAR). 2. All prices must be firm and fixed from the tender closing date and for the duration of the contract 3. All the consortium or joint venture partners must submit a complete set of the latest audited financial statements. 4. All bidders must cost according to the costing template provided or this will lead to disqualification. 5. The cost of installation, delivery, site preparation etc. Must be included in this Comply Do Not Comply proposal. Substantiate / Comments. 6. Comply Do Not Comply No price adjustments that are 100% linked to exchange rate variations shall be allowed. Substantiate / Comments. 7. Comply Do Not Comply The bidder must indicate clearly which portion of the purchase price as well as the monthly costs is linked to the exchange rate. Substantiate / Comments. 8. Comply Do Not comply All additional costs must be clearly specified. Substantiate / Comments. Confidential of 62 RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital. SBD 3.1 PRICING SCHEDULE – FIRM PRICES (PURCHASES) NOTE: ONLY FIRM PRICES WILL BE ACCEPTED. NON-FIRM PRICES (INCLUDING PRICES SUBJECT TO RATES OF EXCHANGE VARIATIONS) WILL NOT BE CONSIDERED. IN CASES WHERE DIFFERENT DELIVERY POINTS INFLUENCE THE PRICING, A SEPARATE PRICING SCHEDULE MUST BE SUBMITTED FOR EACH DELIVERY POINT. Name of bidder: ______________________________________________________________________________ Bid number: RFB069/25/26 Closing Time 11:00 am Closing date: 02 February 2026 Bid Price (Vat incl.) R__________________________________________________________________________ OFFER TO BE VALID FOR 180 DAYS FROM THE CLOSING DATE OF BID. ITEM QUANTITY DESCRIPTION BID PRICE IN RSA CURRENCY NO. ** (ALL APPLICABLE TAXES INCLUDED) - Required by: ___________________________ - At: ___________________________ ___________________________ - Brand and model ________________________ - Country of origin ________________________ - Does the offer comply with the specification(s)? *YES/NO - If not to specification, indicate deviation(s) ________________________ - Period required for delivery _______________________ *Delivery: Firm/not firm - Delivery basis _______________________ Note: All delivery costs must be included in the bid price, for delivery at the prescribed destination. ** “all applicable taxes” includes value- added tax, pay as you earn, income tax, unemployment insurance fund contributions and skills development levies. Confidential of 62 RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital. PRICE DECLARATION FORM Dear Madam /Sir, Having read through and examined the Tender Document, RFB069/25/26, General Conditions, the requirement and all other Annexures to the Tender Document, we offer Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital as detailed in the bid document, for the total Tendered Contract Sum of in: ________________________________________________ (VAT Incl.) Amount in Words R_____________________________________________ (VAT Incl.) Amount in Numbers We confirm that this price covers all activities associated with offer RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital. We confirm that NHLS will incur no additional costs whatsoever over and above this amount in connection with the supply of this solution. We further confirm that all licences required for complete implementation of the solution, and the costs associated therewith, as well as any licences that may be required for future expansion have been fully described and disclosed in this document. We undertake to hold this offer open for acceptance for a period of 180 days from the date of submission of offers. We further undertake that upon final acceptance of our offer, we will commence with delivery when required to do so by the Client. Moreover, we agree that until formal Contract Documents have been prepared and executed, this Form of Tender, together with a written acceptance from the Client shall constitute a binding agreement between us, governed by the terms and conditions set out in this Request for Proposals. We understand that you are not bound to accept the lowest or any offer and that we must bear all costs which we have incurred in connection with preparing and submitting this tender. We hereby undertake for the period during which this tender remains open for acceptance not to divulge to any persons, other than the persons to which the tender is submitted, any information relating to the submission of this tender or the details therein except where such is necessary for the submission of this tender. Confidential of 62 RFB069/25/26: Outright Purchase of a Digital Polymerase Chain Reaction (PCR) system including reagents, consumables, service, and maintenance for a period of five (5) years for the Somatic Cell Genetics Unit at the Charlotte Maxeke Johannesburg Academic Hospital.

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