Sources Sought Notice - FY 2024 - Nucleic Acid Amplification Testing Platform and Reagents.pdf

The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find potential sources to provide a Cost-Per-Test (CPT) Agreement or Reagent Rental Agreement to include reagents instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing for the Brooke Army Medical Center (BAMC) Department of

Pathology and Area Laboratory Services Molecular Laboratory, Fort Sam Houston, Texas. A base period of performance of one year plus four (4) option periods are contemplated.

THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United

States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement.

The Government will use responses to this notice in formulating its acquisition strategy. If the

Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. RHCO-C is seeking the following information (please answer paragraph below with your response):

1. Company name, UEI number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-

Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-

Disabled Veteran-Owned, Small, or Other-than-Small.

2. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate:

Our customer, the Department of Pathology, Microbiology Section, Molecular Laboratory at BAMC requires the following instrument/equipment, reagents, supplies and service:

A. Technology Features for Instrument

The instrument to be provided must be a fully automated molecular analyzer, with the following features:

Capable processing 275 samples with both a CT and GC result, within one eight hour shift using only one person with total hands on time of less than 25 minutes. Up to 750 samples processed in 16 hours

Direct tube sampling capability of primary tube with no cap removal, and no processing of sample prior to loading onto the instrument.

Capable of running multiple amplification technologies at the same time Levy Jennings report to track and trend controls Instrument allows for random access and allows multiple batches to be loaded at various time during the day Hands free on board automatic bar code scanner No need to manually pipette every specimen Prevalence reports to monitor % positivity and % negativity Random Access Capability using on board sample bar code readers with samples and assay requests performed in a random manner, allowing samples to be loaded and tested as they are received throughout the day. Random access is defined as the ability to load patient samples with different test orders randomly in a sample rack and load continuously as the arrive in the lab

The ability to automatically decontaminate and dispose amplification reaction tubes from the assay processing area without operator intervention in a closed system.

A reagent identification system (barcode or other) to automatically link reagent lot and expiration date information to a report accessible from the instrument.

Ability to load samples and let the system run by itself automatically.

Reagent dispense verification and liquid level sensing capability to verify proper dispense of sample and reagents into reaction tube.

Totally integrated platform with sample-in-result-out capability including sample preparation Capable of 1000 reagent tests onboard at one time True positive sample ID with automated onboard sample barcode scanning Automated onboard decontamination of samples Capable of running quality control every 24 hours Scheduled and automated daily maintenance activities Instrument no more than 4 tips per sample Intuitive easy-to-use integrated touchscreen interface Bi-Directional interface capability. Includes safe memory for programs with file protection scheme. Software is menu driven and the user is able to protect programs against unauthorized modifications.

Ability to perform maintenance steps automatically at times scheduled by operator Previous validation by other users extra genital specimens A sleep mode that allows instrument to draw less power when not in use Can load up to four different reagent kits at one time

Can process both qualitative and quantitative FDA-approved or FDA-cleared Nucleic Acid Amplification Tests (NAATs), such as Transcription Mediated Amplification (TMA) and Real-Time PCR, etc.

Must process all specimen type identically and simultaneously with no specimen removal

B. Provide reagents for CR/Molecular assays:

• SARS-CoV-2

• SARS-CoV-2 & Flu A/B (CAB)

• Bacterial Vaginosis (BV)

• Candida Vaginitis and Trichomonas Vaginalis (CV/TV)

• Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC)

• Mycoplasma genitalium

• Trichomonas Vaginalis

Must have FDA approved genetic testing

Must have quality control standards that meets or exceeds all accreditation requirements.

Must be able to meet molecular workflow requirements at least:

Test Annual Tests

SARS-CoV-2 65,000

SARS-CoV-2 & Flu A/B (CAB) 30,000

Bacterial Vaginosis (BV) 2,200

Candida Vaginitis and Trichomonas Vaginalis

(CV/TV)

2,200

Trichomonas Vaginalis 10,000

Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC)

40,000

Mycoplasma genitalium 2,200

Chlamydia trachomatis/ Neisseria gonorrhoeae Nucleic Acid Amplification Assay

1. The assay must utilize nucleic acid amplification technology (NAAT) for the detection of

Chlamydia trachomatis and Neisseria gonorrheae (CTGC) in clinician collected endocervical swabs, male urethral specimens, female/male urines, vaginal swabs (both patient and physician collected), clinician collected throat and rectal swabs.

2. The assay must be approved by the Bureau of Biologics of the Food and Drug Administration (FDA) for in vitro diagnostic use with either symptomatic or non-symptomatic patients using either clinician collected endocervical swabs, male urethral swabs, female/male urine specimens, clinician collected vaginal specimens, clinician collected throat and rectal swabs and alternate specimen sources validated by CLIA regulations.

3. Must process all specimen types identically and simultaneously with no specimen segregation or analyst manipulation such as cap removal, swab expression, swab removal or centrifugation.

Except for the addition of consumables, assay must not require any manual steps by user or additional processing of specimens after specimens are accessioned and loaded onto rack. Sample and transport tubes must have the ability to be loaded onto the system without additional sample preparation steps.

4. Assay can be run in conjunction with other assays using the original patient sample

5. The assay’s performance should not be affected by either naturally occurring components in patient samples such as blood, mucous, or bilirubin, or man-made components such as vitamins or gynecological products.

6. The assay should not cross-react with organisms other than CTGC or cross react with non-gonoccoccal Neisseria species. Assay must allow for testing and establishment of performance specifications to detect Chlamydia trachomatis and Neisseria gonorrhoeae from rectal and oropharyngeal infections, or extra genital sites, to satisfy CMS regulations and CLIA compliance for test modifications from previously tested test specimens.

7. The assay must have FDA acknowledged sensitivity (versus patient infected status) of at least 95% (Chlamydia trachomatis) and 90% (Neisseria gonorrhoeae) with a specificity (versus patient infected status) of at least 99% for both analytes.

8. The Vendor will provide at no additional cost all specimens, specimen collection kits, reagents, test kits, etc., required to verify the assay system to satisfy the current CLIA-88 requirements for verification. Anticipated volume for method verification is 100 tests. Successful completion required for final acceptance.

Vaginitis (BV, CV & TV) and Mycoplasma genitalium Nucleic Acid Amplification Assay

1. The assays must utilize nucleic acid amplification technology (NAAT) for the detection of bacterial vaginosis (BV), candida (CV), trichomoniasis (TV) and Mycoplasma genitalium in vaginal swabs both patient and physician collected.

2. Applicable collection and transport kits should also be provided.

3. The assays must be approved by the Bureau of Biologics of the Food and Drug Administration (FDA) for in vitro diagnostic use with symptomatic patients using either patient or physician collected vaginal swabs.

4. The assays use NAAT technology. The BV assay must establish a ratio of (good vs bad bacterial indicators) to determine infection status. The CV/TV assay must detect Candida Species and speciate out Candida glabrata and Trichomoniasis to provide independent results. And the Mycoplasma genitalium assay must detect Mycoplasma genitalium out and to provide independent results.

5. Must process all specimen types identically and simultaneously with no specimen segregation or analyst manipulation such as cap removal, swab expression, swab removal or centrifugation.

Except for the addition of consumables, assays must not require any manual steps by user or additional processing of specimens after specimens are accessioned and loaded onto rack. Sample and transport tubes must have the ability to be loaded onto the system without additional sample preparation steps.

6. The vaginitis assays can be programmed with bi-directional LIS on Panther. Once the sample is loaded, all assays (BV, CV/TV, Mycoplasma genitalium) will process & result out automatically without user intervention.

7. Assays can be run in conjunction with other assays using the original patient sample. 2 additional assays are able to be performed from the original swab specimen (4 assays total).

8. The assay’s performance should not be affected by either naturally occurring components in patient samples such as blood, mucous, or bilirubin, or man-made components such as vitamins or gynecological products.

9. The assay should not cross-react with organisms other than the vaginitis targets.

10. The Vendor will provide at no additional cost all specimens, specimen collection kits, reagents, test kits, etc., required to verify the assay system to satisfy the current CLIA-88 requirements for verification. Anticipated volume for method verification is 100 tests. Successful completion required for final acceptance.

SARS CoV-2 Nucleic Acid Amplification Assay and SARS CoV-2/Flu A/B Multiplex Assay

The assay must utilize nucleic acid amplification technology for the detection of SARS CoV-2 in clinician collected nasopharyngeal swabs on Viral Transport Media. The assays must run on a fully automated molecular analyzer.