N6264517Q0018_Amendment0002.pdf

N6264517Q0018

Amendment 0002 14 August 2017

Description of Amendment/Modification:

The purpose of this amendment is to answer questions received regarding the solicitation. The hour and date specified for receipt of offer is not extended. There are no other changes.

The following have been added by full text:

AMENDMENT 0002

Question 1:

Your statement of works states:

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 β-glucuronidase must be an added component of one of the reagent(s) used on the Beckman Coulter analyzers.

The “Vendor Name” immunoassay procedure does not require β-glucuronidase and can detect Nordiazepam, Oxazepam, Temazepam, Lorazepam, and Alpha-Hydroxy-Alprazolam at concentrations equal to or greater than the required 200ng/mL. Please see the table below with the cross reactivity levels indicated at a 200ng/mL cutoff.

Table 6: Cross Reactivity with Related DrugsAnalytes

Conc (ng/mL)

% Cross- React.

Oxazepam 200 100.0 Alpha-hydroxyalprazolam

110 181.8

Alprazolam 120 166.7 7-Aminoclonazepam 100,000 <0.002 7- Aminoflunitrazepam

3,500 5.7

7-Aminonitrazepam 35,000 0.6 Bromazepam 750 26.7 Chlordiazepoxide 1,600 12.5 Clorazepate 200 100.0 Clobazam 650 30.8 Clonazepam 180 111.1 Demoxepam 5,500 3.6 Desalkylflurazepam 75 266.7 Diazepam 100 200.0 Estazolam 225 88.9 Flunitrazepam 125 160.0 Flurazepam 110 181.8 Lorazepam 60 333.3 Lorazepam Glucuronide

180 111.1

Lormetazepam 50 400.0

Medazepam 500 40.0 Midazolam 40 500.0 Nitrazepam 700 28.6 Norchlordiazepoxide 2,200 9.1 Nordiazepam 180 111.1 Oxazepam Glucuronide

1,300 15.4

Prazepam 95 210.5 Temazepam 110 181.8 Temazepam Glucuronide

700 28.6

Triazolam 50 400.0

Will you consider our submission to your solicitation provided that our immunoassay meets all criteria with the added benefit of not requiring the additional β-glucuronidase enzymatic hydrolysis procedure?

Answer 1:

The Department of Defense (DOD) Drug Demand Reduction Program (DDRP) is testing urine specimens that contain conjugated drug (i.e. temazepam-glucuronide), and the DoD DDRP needs to be able to detect such compounds. As a result, the Government’s requirements will not be amended.

The Government encourages all qualified offerors to submit a proposal in accordance with Addendum to 52.212-1 Instructions to Offerors.

(End of Summary of Changes)