NP86626 - Swab Collection Devices

Description

The proposed framework is for the supply and delivery of Sample Collection devices and consumables consisting of individual tubes and in vitro kits (IVD) prefilled with Viral Transport Medium (VTM) and Inactivating Medium , swabs, lysis buffer, and complementary accessories. The scope of products in relation to MSS has been extended to cover all Viral and Bacterial testing not just SARS-COV-2) Lot 1: VTM Pre-Filled Tubes VTM is supplied in a colour free plastic (polypropylene) tube containing a prefilled level of transport medium. VTM is intended to be used for the collection and preservation and/or transportation of clinical specimen (e.g. mucus, sputum, vaginal secretions, faeces, urine) collected from any body part for in vitro diagnostic procedures. Lot 2: VTM Collection Kit Sample Collection Kit 1ml fill VTM IVD Kit contains prefilled tube containing 1ml of VTM with green screw cap and sterile swab with Breakpoint. Sample Collection Kit 3ml fill VTM IVD Kit contains prefilled tube containing 3ml of VTM with green screw cap and sterile swab with Breakpoint. Lot 3: Inactivation Medium Pre-Filled Tubes Individual Tubes containing Inactivation Medium Tube containing 2ml pre-filled level of Inactivation Medium, with RED screw cap. Inactivation medium is supplied in a colour free plastic (polypropylene) tube containing a prefilled level of inactivation medium. Inactivation medium is intended to be used for the collection and preservation and/or transportation of clinical specimen (e.g. mucus, sputum, vaginal secretions, faeces, urine) collected from any body part for in vitro diagnostic procedures. Inactivation medium will KILL (inactivate) both viral and bacterial pathogens. Lot 4: Inactivation Collection Kit Sample Collection Kit (tube + swab), containing Inactivation Medium Supplied in IVD Peel Pouch containing 2ml fill of Inactivation medium, with RED screw cap and Sterile dry swab with Breakpoint Lot 5: Individual Sterile Dry Swabs with Breakpoint A Sterile swab is a medical device used to collect specimens from any body part for in vitro diagnostic purposes. The swab will have a flexible polystyrene shaft with viscose, floxsynthetic or flocked, mini tip, colour white, PCR ready and sterile, with a scored break point and fits securely (once broken) in the tube using a method of capturing the swab securely within the screw cap of tube. The swab will be supplied in a peel pouch format and marked with CE number or equivalent UKCA, IVD, storage conditions, sterile, manufacture, part number, lot number and expiry date as a minimum, supplied individually or as part of an IVD PCR Sample collection peel pouch kit. Swabs will be used to collect viral and bacterial targets from various orifices of the human body, such As: Nasal, throat, ear, cervix, nasopharyngeal, skin, toe nails, vaginal and urethral. Lot 6: Miscellaneous Consumables This lot captures a range of miscellaneous products, which may be required for use across NHS Scotland’s Laboratory Estate. The range of products contained within this lot are as follows, Item 1 1 Litre bottle inactivation medium (lysis buffer) Item 2 Replacement blue screw caps Item 3 7ml tube (empty) and loose yellow caps Item 4 Individual Sterile packaged dry swabs without break point. - A Sterile swab is a medical device used to collect specimens from any body part for in vitro diagnostic purposes. The swab will have a flexible polystyrene shaft with viscose, flosynthetic or flocked, mini tip, colour white, PCR ready and sterile, with a scored break point and fits securely (once broken) in the tube using a method of capturing the swab securely within the screw cap of tube. The swab will be supplied in a peel pouch format and marked with CE number or equivalent UKCA, IVD, storage conditions, sterile, manufacture, part number, lot number and expiry date as a minimum, supplied individually or as part of an IVD PCR Sample collection peel pouch kit. Swabs will be used to collect viral and bacterial targets from various orifices of the human body, such As: Nasal, throat, ear, cervix, nasopharyngeal, skin, toe nails, vaginal and urethral. Item 5 Transport pack UN3373 compliant for various tube sizes – sealed bag for internal transportation. Item 6 Transport pack UN3373 compliant for various tube sizes – sealed bag with absorption pad for internal and external transportation by courier or Royal Mail. Item 7 Transport pack UN3373 compliant for various tube sizes – rigid container for use in securely transporting by courier or Royal Mail. Material optional, not limited to hard plastic or cardboard. Lot 7: Additional Products Item 4 Individual Sterile packaged dry swabs without break point. - A Sterile swab is a medical device used to collect specimens from any body part for in vitro diagnostic purposes. The swab will have a flexible polystyrene shaft with viscose, flosynthetic or flocked, mini tip, colour white, PCR ready and sterile, with a scored break point and fits securely (once broken) in the tube using a method of capturing the swab securely within the screw cap of tube. The swab will be supplied in a peel pouch format and marked with CE number or equivalent UKCA, IVD, storage conditions, sterile, manufacture, part number, lot number and expiry date as a minimum, supplied individually or as part of an IVD PCR Sample collection peel pouch kit. Swabs will be used to collect viral and bacterial targets from various orifices of the human body, such As: Nasal, throat, ear, cervix, nasopharyngeal, skin, toe nails, vaginal and urethral. Item 5 Transport pack UN3373 compliant for various tube sizes – sealed bag for internal transportation. Item 6 Transport pack UN3373 compliant for various tube sizes – sealed bag with absorption pad for internal and external transportation by courier or Royal Mail. Item 7 Transport pack UN3373 compliant for various tube sizes – rigid container for use in securely transporting by courier or Royal Mail. Material optional, not limited to hard plastic or cardboard.