Benzodiazepine Immunoassay reagent kits.

This is a Request for Information (RFI)) to determine the availability of potential business sources capable of providing FDA and Quality management Documented Benzodiazepines immunoassay reagent kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting nordiazepam, oxazepam, temazepam, lorazepam, and alpha-hydroxyalprazolam in human urine samples. The vendor shall supply β-glucuronidase reagent in addition to what is included in the reagent kits. Proposals shall comply with the Statement of Work (SOW).

The materials shall be for the initial (screen) immunoassay for the detection of nordiazepam, oxazepam, temazepam, lorazepam, and alpha-hydroxyalprazolam (benzodiazepines) in urine to include a β-glucuronidase enzymatic hydrolysis procedure. When using the vendor’s recommended calibrator at a concentration of 200 ng/mL, the testing reagent shall be used to detect in urine the select benzodiazepines (nordiazepam, oxazepam, temazepam, lorazepam, alpha-hydroxyalprazolam) when present individually or in combination at a urine concentration equal to or greater than 200 ng/mL. The reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers, in use at the Department of Defense (DoD) Forensic Toxicology Drug Testing Laboratories (FTDTLs), and shall be compatible without modification of the equipment. The immunoassay procedure is limited to a two reagent assay procedure with one of the reagents to contain β-glucuronidase. The β-glucuronidase must be an added component of one of the reagent(s) used on the Beckman Coulter analyzers. A vendor immunoassay reagent proposal that requires a separate manual or automated addition of the β-glucuronidase to each testing specimen prior to testing on the Beckman Coulter analyzers will not be considered acceptable in this solicitation. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor’s reagent on the analyzer.

Vendors shall be Compliance with Food & Drug Administration (FDA) Requirements.

In addition, the required services shall be performed in accordance with DoD Instruction 1010.16 Technical Procedures for the Military Personnel Drug Abuse Testing Program dated 15 June 2020.

The reagent kits are required for a period of performance of up to five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month

Vendors are asked to provide information to their ability to provide the following:

The following drug cutoffs (in ng/mL) are currently used by DoD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

11-nor-delta-9-THC-carboxylic acid (THC) 50, 15;

Benzoylecgonine (BZE) 150, 100;

Morphine (MOR) 300, 4000;

Codeine (COD) 300, 2000;

Hydrocodone (HYDC) 300, 100;

Hydromorphone (HYDM) 300, 100;

6-acetylmorphine (6AM) 10, 10;

Oxycodone (OXYC) 100, 100;

Oxymorphone (OXYM) 100, 100;

D-amphetamine (AMP) 500, 100;

D-methamphetamine (MET) 500, 100;

Methylenedioxymethamphetamine (MDMA) 500, 500;

Methylenedioxyamphetamine (MDA) 500, 500;

Benzodiazepines (BZD) -

Nordiazepam (NORD) 200, 100;

Oxazepam (OXAZ) 200, 100;

Alpha-hydroxyalprazolam (AHAL) 200, 100;

Lorazepam (LORA) 200, 100;

Temazepam (TEMA) 200, 100;

Synthetic cannabinoids (SYCAN) –

JWH-018 (J018) 10, 1;

JWH-073 (J073) 10, 1;

UR-144 (U144) 10, 1;

MAM-2201 (MAM22) 10, 1;

AB-CHIMINACA (ABCHM) 10, 1;

AB-PINACA (ABPIN) 10, 1.

4MBUT (CAYMAN) 10. 1.

4MBTN (CAYMAN) 10. 1.

5FADB (CAYMAN) 10. 1.

5MPCA (CAYMAN) 10. 1.

ADBTN (CAYMAN) 10. 1.

ABFUB (CAYMAN) 10. 1.

M4PIN (CAYMAN) 10. 1.

MFUBN (CAYMAN) 10. 1.

Lysergic Acid Diethylamide (LSD) 0.5, 0.2.

This RFI is not a request for competitive proposals and no solicitation document exists for this requirement as yet. Please ensure that the company name, address, point of contact Information (including phone number and email), business size/designation, and Cage Code is included with the response. Please direct any questions concerning this RFI notice to Mr. Curtis Cardoza at Curtis.e.cardoza.civ@health.mil.