Request for Information (RFI): Challenges and Opportunities for the Development of a Point of Care Device for the Diagnosis of Sickle Cell Disease

Notice Number: NOT-HL-12-140

Key Dates

Release Date: April 4, 2012

Issued by

National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)


This Request for Information (RFI) is directed toward determining the types of technologies that could be used for the development of a point of care (POC) device for the diagnosis of Sickle Cell Disease in newborns and young children in low-income and low-resources settings. This information will be used to assess the current state of the field and identify potential companies/universities with the interest and expertise to engage in this research.


The World Health Organization (WHO) has declared Sickle Cell Disease (SCD) a public health priority. The greatest burden of SCD is in sub-Saharan Africa, where 75% of the 300,000 annual global births of affected children live. Estimates suggest that 50-80% of these children will die by 5 years of age. While treatment options are currently available, in order for affected populations to benefit from these therapies it is important to be able to identify those who require treatment and to administer appropriate therapies in a timely way. In rural parts of Africa, particularly Sub-Saharan Africa, a SCD diagnosis is rarely made before the age of 2-3 years, and many undiagnosed children die in early infancy due to potentially treatable illnesses such as meningitis, pneumonia or acute anemia. Traditional neonatal screening for SCD is not an effective diagnostic intervention in this setting. A more pragmatic use of limited health care fiscal resources in low-income countries would involve the widespread integration of highly sensitive and specific POC testing into the infant s /child’s first acute care visit at a local medical facility. The implementation of a low-cost and accurate POC diagnostic device would allow earlier SCD testing, diagnosis, and acute and long term treatment of children, thereby reducing the risk of future SCD-related complications.

Information Requested

NHLBI requests responses to all or some of the following items:

  • Identify the scientific technologies such as molecular, biochemical, genomic, microfluidic, HPLC, etc. that have the potential for POC application in low-resource settings. Device characteristics in such a setting would include: cost efficiency, rapid response, specificity, low maintenance, reliability, portability, ease of operation, and energy efficiency. The device must be capable of differentiating homozygotes (SS) from heterozygotes (AS). Comment as to whether the device could be adapted to detect other major hemoglobinopathies such as Thalassemia. Include a statement whether a new device may be required or if existing medical devices could be adapted.
  • Since the intended POC user will not typically have laboratory training, and the patient-side blood testing environment is not as controlled as the standard laboratory environment, describe how the POC product design could achieve the laboratory’s standard of analytical performance (e.g., robustness).
  • Identify obstacles to developing POC devices in low-resource settings and provide recommendations for overcoming them. Recommendations may include specific funding mechanisms or programs that would enhance the development of POC device.
  • Identify any ethical issues related to device development in children, particularly in non-emergency settings, that should be addressed when planning a device development program.
  • Provide input on current pediatric device regulatory requirements.


Responses to this RFI are voluntary. Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Only the de-identified comments will be used. Proprietary, classified, confidential, or sensitive information should not be included in your response. The United States government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States government to provide support for any ideas identified in response to it. Please note that the United States government will not pay for the preparation of any information submitted or for its use of that information. Responses will be compiled and shared internally and with the National Heart, Lung, and Blood Advisory Council, with one or more subcommittees of the Council, and with scientific working groups convened by the NHLBI, as appropriate. In all cases where responses are shared, the names of the respondents will be withheld.

How to Submit a Response

Interested extramural investigators and other interested parties are invited to respond.

Responses to this RFI will be accepted through May 4, 2012. You will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information.

All comments must be submitted via email (include NOT-HL-12-140 in the subject line) to the following:

Manjit Hanspal, Ph.D.


Specific questions about this RFI should be directed to the following:

Manjit Hanspal, Ph.D.
Program Director
Blood Diseases Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, MSC 7950, Room 9158
Bethesda, MD 20892-7950
Tel: 301-435-0050; Fax: 301-480-1046

Susan Pucie
Senior Program Analyst
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
301-480-0867 fax