---
title: "Molecular Screening Services"
ocid: "ocds-h6vhtk-03b3e2"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03b3e2"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-03b3e2.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-03b3e2.json"
source: "Find A Tender Service"
current_stage: "Planning"
buyer: "NHS BLOOD AND TRANSPLANT"
published: "2023-03-17"
---

# Molecular Screening Services

Buyer: NHS BLOOD AND TRANSPLANT  
Current stage: Planning  
OCID: ocds-h6vhtk-03b3e2

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## Summary

The NHS Blood and Transplant organisation is planning a procurement process called "Molecular Screening Services" in the diagnostic supplies industry category. The tender aims to acquire a fully integrated high throughput testing solution for nucleic acid amplification testing. Interested organisations must declare their interest by 17th April 2023 and be prepared to participate in future engagement sessions in March/April 2023.

This tender opportunity from NHS Blood and Transplant can be beneficial for businesses involved in laboratory services, automation systems, diagnostic kits, and medical consumables. Companies with expertise in supplying CE/UKCA marked devices for cadaveric donors, and capable of meeting the specific testing requirements, are well-suited to compete. The procurement stage is in the planning phase, with a deadline of 17th April 2023 for organisations to express interest and submit relevant documentation for participation.

## Notice

This Prior Information Notice (PIN) is a call for competition and is separate to any tender opportunity. Its purpose is to inform the market of an up-and-coming tender opportunity. NHSBT are looking for a fully integrated high throughput testing solution for an automated Nucleic Acid Amplification Testing (NAT) system which can detect HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA in EDTA plasma from blood and non-blood (e.g. stem cell, tissue) donors including from deceased (non-heart beating) donors. The solution must have the relevant CE/UKCA marking to support this ability. 
Organisations who express an interest must declare this by 17th April 2023 including a statement confirming their current participation in a Kit Evaluation Group (KEG) evaluation, or their intention to join the KEG process, or confirmation that their testing solution has previously been KEG approved. Any organisations wishing to participate in the KEG evaluation process must also submit their relevant assay Instructions For Use (IFU) by 17th April 2023 to tennille.madigan@nhsbt.nhs.uk

Organisations who express an interest to participate will be invite to future engagement sessions in March/April 2023.

### Lot Information

Lot 1

NHSBT requires a direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated solution, which must include all the necessary equipment, installation, maintenance, consumables, reagents, software, including an inter-operability provision with NHSBT's existing IT infrastructure, and an overall on-going support mechanism that may be required to carry out the necessary testing as stated below. 
All in vitro diagnostic medical devices, for example, instruments, consumables, and reagents must be CE/UKCA marked for specifically cadaveric donors. 
Great Britain (GB) will continue to recognise CE marking under the IVDD or IVDR until 30 June 2024 and from 1 July 2024 devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended. The end-to-end solution must be capable of producing test results in a format that can be utilised by NHSBT's host IT system. NHSBT are looking for a fully integrated, high throughput, automated Nucleic Acid Amplification Testing (NAT) screening system which can detect HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA in EDTA plasma samples from blood and non-blood (e.g. stem cell, tissue) donors including samples from deceased (non-heart beating) donors, as individual donations i.e.: not pooled
Molecular Screening will be performed by NHSBTs Microbiology Services Laboratory in Colindale (London) with the following approximate number of samples (based on historical actual tests) per marker per year for both donation screening and confirmatory testing: 
* HBV DNA: 7,381 screening tests as part of a multiplex & 1,082 individual tests for confirmatory testing
* HIV-1/HIV-2 RNA: 7,381 screening tests as part of a multiplex & 652 individual tests for confirmatory testing
* HCV RNA: 7,381 screening tests as part of a multiplex & 640 individual tests for confirmatory testing
* HEV RNA: 7,126 individual tests for either screening or confirmatory testing
* Pooling is not required, all samples will be tested as an individual donation.

It is important that interested parties respond to this PIN, as prior KEG approval will be a mandatory requirement for any associated future tender opportunity, in-line with the requirements of the Guidelines for the Blood Transfusion Services in the United Kingdom (Red Book - https://www.transfusionguidelines.org/red-book). NHSBT will seek to understand the status of assays which would be offered with regards to KEG. Any organisations wishing to participate in the KEG evaluation process must also submit their relating assay IFUs by 17th April 2023 to tennille.madigan@nhsbt.nhs.uk 
Further details on KEG and the process will be provided during Supplier Engagement. The format of Supplier Engagement will be communicated to those organisations that respond to this PIN; however, this is likely to be virtual meetings conducted via Microsoft Teams during March/April 2023. Expressions of interest should be e-mailed to tennille.madigan@nhsbt.nhs.uk by 17th April 2023.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/007841-2023 |
| Notice type | Planning Notice |
| Procurement type | Standard |
| Procurement category | Goods |
| Procurement method | Not Specified |
| Procurement method details | Not specified |
| Tender suitability | Not specified |
| Awardee scale | Not specified |
| All stages | Planning |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 17 Mar 2023 |
| Submission deadline | Not specified |
| Future notice date | 3 May 2023 |
| Award date | Not specified |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £3,800,000 |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Planned |
| Lots status | Planned |
| Awards status | Not specified |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | NHS BLOOD AND TRANSPLANT |
| Locality | BRISTOL |
| Post town | Bristol |
| Postcode | BS34 7QH |
| Country | England |
| ITL 1 | TLK South West (England) |
| ITL 2 | TLK5 West of England |
| ITL 3 | TLK52 Bath & North East Somerset and South Gloucestershire |
| Local authority | South Gloucestershire |
| Electoral ward | Filton |
| Westminster constituency | Filton and Bradley Stoke |
| Delivery location | Not specified |

## CPV Codes

### Divisions

- 33 - Medical equipments, pharmaceuticals and personal care products
- 48 - Software package and information systems
- 71 - Architectural, construction, engineering and inspection services

### Codes

- 33000000 - Medical equipments, pharmaceuticals and personal care products
- 33124000 - Diagnostics and radiodiagnostic devices and supplies
- 33124110 - Diagnostic systems
- 33124130 - Diagnostic supplies
- 33127000 - Immuno-analysis devices
- 33140000 - Medical consumables
- 33141625 - Diagnostic kits
- 33696200 - Blood-testing reagents
- 33696500 - Laboratory reagents
- 48921000 - Automation system
- 71900000 - Laboratory services

## Release History

- 17 Mar 2023 at 13:31 - Planning - Planning Notice - https://www.find-tender.service.gov.uk/Notice/007841-2023

## Notice URLs

- https://health-family.force.com/s/Welcome
- https://www.nhsbt.nhs.uk/
- https://www.transfusionguidelines.org/red-book

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03b3e2. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-03b3e2.json.