The Government is requesting information from interested and capable sources for commercial items to meet the Government's requirement for a Clinical Diagnostic System. The information provided must contain enough detail to demonstrate ability to meet the Government's requirement as listed in the Required Specifications List below. The responses are for informational purposes only and do not obligate the Government or Contractor in any way.

Responses should include the following information:

1.) Delivery lead time, FOB Destination, to Point Loma California. If partial deliveries are an option, please advise. The Government requires delivery by the following dates, if possible:

CLIN 0001: Quantity of nine (9) each Filmarray instruments systems with required delivery by July 1, 2013.

CLIN 0002: Respiratory Panels (100 each) - required delivered by: July 1, 2013, 40 Reagent Pouches; October 1, 2013, 20 Reagent Pouches; February 3, 2014, 20 Reagent Pouches; and May 1, 2014, 20 Reagent Pouches.

Please identify the latest possible ordering date by the Government to receive the items by the required dates above.


2.) Description of the Requirement:

Clinical Diagnostic System (9 each instrument systems) and Respiratory Panels (100 each). The Reagent pouches should be delivered with the system.

a. Acute respiratory infections are the leading causes of mortality and morbidity worldwide. Recent increases of H5N1 Avian Influenza deaths in Cambodia have increased concerns regarding potential development of pandemic influenza infections originating from SE Asia. NAMRU-2 Detachment Phnom Penh has been directed by the US Embassy to serve as the lead for Cooperative Threat Reduction and Defense Threat Reduction Activity efforts in Cambodia. NAMRU-2, in collaboration with the Department of Operational Infectious Diseases at the Naval Health Research Center and in consultations with the Cambodia Ministry of Health and the Cambodian National Public Health Institute have identified requirement to enhance laboratory capacity in key districts affected by recent H5N1 outbreaks. Molecular diagnostic assays are the gold standard for definitive pathogen identification and capability that allows for rapid (less than 2 hrs) screening against multiple pathogens simultaneously is needed. The first line of screening needs to include differential diagnosis of viral and bacterial pathogens known to induce acute respiratory symptoms and disease, including Influenza A, Influenza B, Adenovirus, Parainfluenza Virus (1-4), Coronavirus (HKU1, NL63, 229E and OC43), human Metapneumovirus, and Enterovirus/rhinovirus, Respiratory Syncytial Virus (RSV), Bordetella pertussis, Chlamydia pneumonia, and Mycoplasma pneumoniae. Because of the primary concern to determine Influenza A subtype, the additional capability to identify different subtypes of Influenza A virus is also required.

b. FUNCTIONAL COMPLIANCE: FDA-approved multiplex assay for simultaneous molecular characterization of human respiratory viruses and bacterial pathogens in clinical samples described as follows: Influenza A (subtype H1, H3, and pH1), Influenza B, Adenovirus, Parainfluenza Virus (1-4), Coronavirus (HKU1, NL63, 229E and OC43), human Metapneumovirus, and Enterovirus/rhinovirus, Respiratory Syncytial Virus (RSV), Bordetella pertussis, Chlamydia pneumonia, and Mycoplasma pneumoniae. Simple and integrated sample preparation which does not require a separate nucleic acid extraction step. Does not require use of pipettes or other sophisticated liquid handling devices/instrumentation for sample and reagent handling. Minimal technical manipulation and hands-on time for sample preparation. Fast assay run-time with results provided in less than 2 hrs.

c. VALIDATION COMPLIANCE: The Clinical Diagnostic System must meet Department of Defense and Epidemic Outbreak Surveillance (EOS) Advanced Concept Technology Demonstration (ACTD) needs and objectives. Reference: The Johns Hopkins University Applied Physics Laboratory completed a quantitative assessment on current state of bio-detection technologies/instrument systems and the technologies that most closely align with EOS, an ACTD program, objectives (2009). While the activity in Cambodia is distinct from the ACTD, the requirements for sustainability in austere environments indicate the assessment is applicable. Please indicate an ability to meet the sustainability requirements in austere environments.

d. Warranty/Maintenance Provisions/Help Desk Support/On-line Resources - References, technical notes, manuals, software updates, etc.


Please provide and questions and your responses to the Sources Sought notice to the following individual:

Mr. John Shawki
100 Medway Rd. Suite 305
Milford, MA 01757
[email protected]

Responses should adequately provide enough information to demonstrate the interested party's item meets the requirements listed above. Please provide a response by Thursday 9 May 2013 at 5:00 PM EST.

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