---
title: "Hepatitis A virus (HAV) RNA & Parvovirus B19 DNA Testing Services"
ocid: "ocds-h6vhtk-03b3e0"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03b3e0"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-03b3e0.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-03b3e0.json"
source: "Find A Tender Service"
current_stage: "Planning"
buyer: "NHS BLOOD AND TRANSPLANT"
published: "2023-03-17"
---

# Hepatitis A virus (HAV) RNA & Parvovirus B19 DNA Testing Services

Buyer: NHS BLOOD AND TRANSPLANT  
Current stage: Planning  
OCID: ocds-h6vhtk-03b3e0

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## Summary

The NHS Blood and Transplant organisation is planning a tender for the provision of integrated testing services for hepatitis A virus (HAV) RNA and Parvovirus B19 DNA. The procurement falls under the 'goods' category and is specifically for diagnostic supplies. Located in Colindale London, the organisation is seeking a high throughput testing solution with a value of £5,600,000. Interested parties must declare interest by 17th April 2023 and demonstrate participation in the Kit Evaluation Group evaluation process or express intention to join. The solution requires CE/UKCA marking and the ability to conduct various tests including HBV DNA, HIV RNA, HCV RNA, and more on plasma samples. Suppliers need to submit relevant assay Instructions For Use to the specified email address by the deadline.

This tender opportunity by the NHS Blood and Transplant organisation in the UK presents a substantial business opportunity for providers of diagnostic supplies and laboratory services. Companies capable of delivering fully integrated high throughput testing solutions, including equipment, consumables, reagents, and software, with UKCA marking will find this tender suitable for their expertise. The deadline for expressions of interest is 17th April 2023, with further details on the procurement process to be provided during Supplier Engagement sessions likely to be held virtually via Microsoft Teams in March/April 2023. This opportunity aligns with the healthcare sector's growing need for advanced testing solutions to support critical screening services.

## 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 the detection of hepatitis A virus (HAV) RNA and Parvovirus B19 DNA in partnership with NHSBT. Additionally, the solution must also be able to test for HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA as contingency during a business continuity need for NHSBTs Molecular Screening Service located in Colindale London. The solution must have the relevant UKCA marking to support this ability. 

Organisations who express an interest must declare this by 17th April 2023 date including a statement confirming their current participation in a Kit Evaluation Group (KEG) evaluation or their intention to join the KEG process. 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

### 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 EDTA plasma drawn from blood donors. Other specific requirements are outlined below. 
The solution: 
A s Fully integrated high throughput testing solution is required for screening blood and plasma donors for HAV RNA and Parvovirus B19 DNA. Samples will be pooled prior to screening therefore pooling equipment is also required as part of the solution. 
The HAV RNA and Parvovirus B19 DNA testing solution must have the ability to test EDTA plasma samples from blood & plasma donors that have been stored frozen for up to 2 years at minus 20 degrees (-20). 
In addition, the solution will be required to support NHSBT's Microbiology Services Laboratory, a small specialist laboratory based in Colindale, solely in a contingency role to support NHSBT business continuity for essential screening services, therefore the testing solution MUST also have the ability to test the following as individual donations ie not pooled ) using the same analyser as for HAV and B19: HBV DNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, HEV RNA in EDTA plasma samples from non-blood (e.g. stem cell, tissue) donors including those from deceased (non-heart beating) 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 (PULSE) system. 
HAV RNA and Parvovirus B19 DNA testing will be performed at an purpose built NHSBT laboratory based in Manchester with the following approximate number of samples per marker per year for donation screening: 
Throughput: Approx: 146,000 samples per month until July 2024; July 2024 onwards 95,000 samples per month
Molecular Screening Throughput Contingency 
The HAV & B19 laboratory will act as a contingency laboratory for the Molecular Screening service. As this is a contingency requirement due to a business continuity need, the numbers of tests required will be variable depending on the business continuity response. We anticipate the numbers to be relatively low compared to HAV and B19 and NHSBT will manage the work flow during a business continuity response working in partnership with the supplier to execute.

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/007839-2023 |
| 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 | £5,600,000 |
| 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 13:28 - Planning - Planning Notice - https://www.find-tender.service.gov.uk/Notice/007839-2023

## 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-03b3e0. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-03b3e0.json.