Inactive

Update - the Closing date of this solicitation is now amended to be on the date of Friday, January 14, 2022 at 3pm Eastern Time (vice the original Friday January 7, 2022 date at 3pm Eastern time. Amen... Update - the Closing date of this solicitation is now amended to be on the date of Friday, January 14, 2022 at 3pm Eastern Time (vice the original Friday January 7, 2022 date at 3pm Eastern time. Amendment 0002 for RFP SPE2DE22R0007 is hereby attached to this notice for the record). ///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// The Defense Logistics Agency is planning to issue a solicitation for multiple Indefinite Delivery-Indefinite Quantity contracts for Single-plex and Multi-plex Point-of-Care (POC) Nucleic Acid Amplification Tests (NAAT) and analyzers for confirmatory testing for SARS-CoV-2. Procurement details follow. The vendors shall supply Single-plex or Multi-plex NAAT tests and analyzers for confirmatory testing that are Food and Drug Administration (FDA) Approved, 510(K) cleared or Emergency Use Authorization (EUA) approved. The specifications for each test are listed below: Single-plex POC NAAT Tests: Must conform to ISO 13485 standards as well as the Quality System Regulations at 21 CFR Part 820 which may include, but is not limited to, the quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis processes. All delivered items shall be clearly labeled and expiration marked on all items. Product delivered shall have at least 75% of the shelf life remaining at time of delivery. Test is authorized for use at the POC (i.e., in patient care settings operating under a CLIA Certificate of Wavier, certificate of Compliance, or Certificate of Accreditation). Reaction chambers containing reagents for the targeted amplification of SARS-CoV-2 viral RNA and an internal control. Any necessary elution buffers. Any necessary components required for reagent transfer. Sterile swabs for use with the test. Positive and negative controls. Limit of Detection Range: ?350 genome equivalents /ml. Inclusivity/Analytical Reactivity (between primer and target): ?95% Cross Reactivity: No significant combined homologies with human genome, other coronaviruses, or human microflora. Time to Result: 30 minutes or less. Automated: Yes Multi-plex POC NAAT Tests: Must conform to ISO 13485 standards as well as the Quality System Regulations at 21 CFR Part 820 which may include, but is not limited to, the quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis processes. All delivered items shall be clearly labeled and expiration marked on all items. Product delivered shall have at least 75% of the shelf life remaining at time of delivery. Test is authorized for use at the Point-of-Care (i.e., in patient care settings operating under a CLIA Certificate of Wavier, certificate of Compliance, or Certificate of Accreditation). Reaction chambers containing beads, lysis reagents, binding reagents, elution reagents and wash reagents for the detection of RNA from Influenza A, Influenza B, Respiratory syncytial virus (RSV) and SARS-CoV-2 virus in either nasopharyngeal swab or nasal swab specimens. Contain all components required to perform the necessary steps and reactions onsite to enable use of its respective platform for analysis and result reporting. Limit of Detection: SARS-CoV-2 (USA-WA1/2020) ?350 genome equivalents/mL; Influenza A/B ?500 genome equivalents/mL; RSV ?500 genome equivalents/ml. Inclusivity/Analytical Reactivity (between primer and target): ?95%. Cross Reactivity: No significant combined homologies with human genome, other coronaviruses, or human microflora. Time to Result: 60 minutes or less. Automated: Yes. The awardees will make deliveries based on United States Government (USG) direction and all delivery locations will be in the CONUS region with the majority of orders going to DLA Distribution Centers in PA. Delivery is to be FOB Destination and delivered within 10 days from date of the delivery order. This will be an unrestricted and fully competitive acquisition. The contracts will be Indefinite Delivery-Indefinite Quantity (IDIQ) type contracts with an eighteen-month base period. The estimated quantity for the Single-plex is 9 million tests and 2,250 analyzers. The estimated quantity for the Multi-plex is 5 million tests and 1,250 analyzers. This is a commercial item and will be solicited using FAR part 12. All sources may submit a proposal which shall be considered by the agency. A copy of the solicitation will be posted to the DLA Bid Board System (DIBBS) at https://www.dibbs.bsm.dla.mil. Interested parties should contact Joan Marie Grace (215-737-2663) (joanmarie.grace@dla.mil) for any questions/comments. Interested parties are further advised to set up automated notifications of presolicitation or solicitation changes through this website. The solicitation date is December 23, 2021. DLA reserves the right to issue the solicitation before or after the projected solicitation date. Note: Offers from Authorized Manufacturer Distributors must include a signed Letter of Commitment from the Manufacturer to be considered for award.