The Home Sputum Collection Project
To enhance the process of nontuberculous mycobacterial (NTM) lung disease detection and diagnosis, the COPD Foundation in partnership with a network of experts at National Jewish Health as well as patient advocates from NTM Info & Research (NTMir) has designed a pilot program aimed at improving the current process for sputum testing. The process improvement project is supported by a generous partnership with Insmed and there will be no cost to the patient or physician as part of the pilot program.
We hope this pilot program will demonstrate that:
- Patients are able to provide sputum samples in the home setting
- We can improve timelines of results and provide access to increased species identification and drug susceptibility testing
- Home sputum collection provides a safe and accessible alternative to producing sputum in the laboratory setting
Currently, an estimated 180,000 people in the U.S. suffer from NTM lung disease with the number of infections increasing by around 8% each year1. Unfortunately, many patients with NTM report years between the onset of their symptoms and diagnosis2. Our goal is to close this gap by tackling common challenges that patients and physicians face with traditional sputum collection methods.
Because many laboratories do not possess the special assays necessary to identify NTM subspecies, this pilot program will use a full-service mycobacteriology laboratory equipped with these assays at National Jewish Health in Denver to ensure accurate diagnosis and targeted treatment for NTM lung disease.
With our home collection process, patients will not have to travel to provide a sputum sample. Instead, they can follow this simple process:
- The prescriber must complete a brief survey to ensure that they are eligible to participate.
- The prescriber may then request a home sputum collection kit for their patient.
- A home collection kit will be mailed directly to the patient from the laboratory. The patient will be asked to follow the instructions on their kit in order to collect a good sputum sample.
- Once the patient is able to collect a quality sputum sample, they will mail their specimen directly to the laboratory at National Jewish Health using the pre-paid label included within their kit.
- When results are available, they will be sent directly from the laboratory to the prescriber.
There will be no cost to the patient and no insurance billing for the duration of the pilot.
Now more than ever, the need for home testing kits is essential. While some patients have access to full-service laboratories like the one at National Jewish Health, many others commonly face inconclusive or sub-par test results. This often necessitates repeated sputum testing and creates diagnosis and treatment delays. We believe that reducing the time period between symptom onset and diagnosis is key to improving the quality of life for individuals afflicted with NTM lung disease. By providing patients around the country access to top tier laboratories through our new home sputum program, we are confident we can achieve this goal together.
Frequently Asked Questions
I am a patient interested in the program. What is my next step?plus
Upon consulting with a physician, patients experiencing symptoms of NTM lung disease may be prescribed a sputum test to be performed at the specialty laboratory at National Jewish Health. A home testing kit will be mailed by this lab to your address within 1-2 weeks. Once you are able to collect a quality sputum sample, please return it to the laboratory as soon as possible using the pre-paid overnight shipping label included in your kit to ensure viability.
I am a physician interested in the program. What is my next step?plus
You will be asked to complete this short survey. If you meet the criteria, you will receive a form via email to complete for the laboratory order. The qualifying criteria are summarized below:
- Licensed in the U.S.
- Located in any state in the U.S. with the exception of NY state (in light of specific testing regulations, this initial program does not include physicians or patients who reside in NY state)
- Has knowledge and experience with individuals suspected or confirmed to have NTM Lung Disease
- Agrees to refer patients who otherwise would not have access to a reference laboratory for NTM Lung Testing or patients who are reluctant to come to the clinic because of concerns related to COVID-19
- Agrees (to the best of your knowledge) to refer patients who understand and agree to the process of collecting sputum at home using the instructions provided in the kit
- Agrees to participate in two (2) anonymous surveys aimed at assessing the utility, impact and challenges of the program
As a patient, how do I address this program with my physician?plus
Please share the website name or link with your physician. If they have additional questions, please ask them to call the COPD Foundation’s Bronchiectasis and NTM Information Line at 1-833-411-LUNG (5864)
As a physician, how many patients can I enroll in this program?plus
A physician may enroll up to five (5) patients, each of whom may submit one (1) sample for testing.
As a physician, what happens if I do not use all five (5) of my enrollment slots?plus
If a physician does not prescribe all five (5) kits while the pilot is active, the remaining kits will be used by another physician. The first check in will occur in December of 2021 to determine whether a prescriber has utilized all of their allotted kits.
What patients would qualify for this pilot program?plus
Both patients who display symptoms of NTM lung disease as well as confirmed NTM patients are eligible to receive a prescription. The prescribing physician may exercise discretion in deciding which patients would likely benefit from a sputum culture.
What will this cost me?plus
This is a pilot program that is funded by the COPD Foundation through a generous partnership with Insmed. There is no cost to patients or prescribers who participate in the pilot.
How long will it take to receive my kit and get my results?plus
After the provider has ordered the patient’s kit, it will be mailed by the laboratory to the patient’s address within 1-2 weeks. Once the patient has followed the instructions on the kit and sent their sample back using the pre-paid overnight label provided, the lab will process the specimen immediately and send the results back to the prescribing physician. Mycobacterial cultures test for special, slow-growing microbes that can take weeks or even months to grow (regular microbes like E. coli will grow in a day). Because of the extended duration of this growth process, it also takes extra time to determine which drugs the bacteria are susceptible to. Unlike routine testing however, the sample does not need to be sent to multiple laboratories to get a complete answer. The full-service lab at National Jewish Health performs all of these testing steps in one place, reducing the total time in transition and ensuring results get back to the physician and patient as soon as possible.
Why is space limited?plus
Because this is a pilot program with a specified budget, only a limited number of patients will have access to the program. It is our hope that this pilot will demonstrate the utility of a national home sputum program.
Is this a research study?plus
No, the pilot program is not a research study. Home collection kits for mycobacteria are already in use and have helped many patients collect quality sputum samples from the comfort, safety, and convenience of their own homes. The COPD Foundation, National Jewish Health and NTM Info & Research developed this process improvement project together to expand our understanding of the barriers that may accompany the use of a home sputum kit as well as to determine the necessity and desire among patients and physicians to continue funding projects like this in the future.
How does this differ from standard sputum collection?plus
This program aims to demonstrate that quality sputum collection can be done by the patient in their own home with instructional materials designed by top pulmonary specialists. The patient can then mail their own sample to a full-service mycobacteriology laboratory that is best equipped to identify various NTM subspecies and provide the most accurate results.
How is testing at a full-service mycobacteriology laboratory testing different from the testing I would usually receive for sputum?plus
The full-service laboratory at National Jewish Health has special assays and expertise to accurately identify mycobacteria. They will identify organisms to the species (or even subspecies, if it is relevant) level instead of the complex level to make sure providers can see exactly what their patients are infected with, or if they have new infections. They will also perform susceptibility testing to assist providers with selecting the most clinically useful antibiotics. Where possible, the lab at NJH will conduct genetic testing on mycobacteria to further expedite the process of selecting the most effective drug for a particular patient’s infection.
- Strollo, S. E., Adjemian, J., Adjemian, M. K., & Prevots, D. R. (2015, October). The Burden of Pulmonary Nontuberculous Mycobacterial Disease in the United States. Annals of the American Thoracic Society. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4627421/.
- U.S. Food and Drug Administration. (2015, October 15). The Voice of The Patient - U.S. Food and Drug Administration. FDA.gov. https://www.fda.gov/media/119500/download.