As we enter a new year, it’s nice to look back and reflect over the past 12 months. At the end of 2015, we were wrapping up our exhibit, meetings and symposium session at the Union World Conference on Lung Health in Cape Town, ZA. This was where we officially launched OMNIgene®•SPUTUM.
Our goal in launching OMNIgene•SPUTUM is to ease the process of collecting, transporting and processing sputum samples; so, together, we can find the “missing 4 million” people who aren’t getting tested for tuberculosis (TB). This ambient-temperature sputum transport reagent has the power to expand patient access to testing, and to help ensure accurate and timely test results by maintaining sample integrity while improving lab efficiency.
Since Cape Town, we have been working with collaborators in different countries to evaluate the potential of OMNIgene•SPUTUM for implementation in national TB programs. At the 2016 Union World Conference in Liverpool, UK, we showcased three journal articles that were published in 2016. These studies demonstrated the reagent’s performance in remote settings, and its compatibility with smear microscopy, solid culture and Xpert®.
Here are the summaries:
- Bhagwan et al. 2016, Journal of Epidemiology and Global Health
This study investigated the collection of 60 sputa from remote collection sites within Nepal. The samples required up to 8 days of transport prior to arriving at the GENETUP laboratory for clinical testing. Each sample was split manually, then randomly assigned to receive either OMNIgene•SPUTUM treatment (reagent added, transport without cold chain) or Nepal’s standard of care (air courier, on ice, to laboratory, NaOH/NALC processing). The evaluations focused on smear microscopy and solid culture, as these are the main diagnostic tests in use at the GENETUP laboratory.
The OMNIgene•SPUTUM group had higher culture-positivity and more “rescues” (i.e., specimen pairs having positive culture with one treatment, contaminated culture with the other). Overall, OMNIgene•SPUTUM performed well in this complex field setting by reducing culture contamination by 10% and improving TB detection by 9%.
- Bhagwan et al. 2016, International Journal of Tuberculosis and Lung Disease; In Press (expected December 2016)
This second field study in Nepal examined the effects of transporting sputa in OMNIgene•SPUTUM from a peripheral site to a central site for rapid molecular testing using the GeneXpert MTB/RIF assay platform. The authors measured whether the reagent improved TB detection and increased the sensitivity of Xpert. One hundred clinical sputa were collected remotely, manually split and assigned the same treatments as the previous publication. Samples were transported between 2 and 13 days prior to testing by smear microscopy and Xpert.
The results showed that the samples shipped in OMNIgene•SPUTUM can undergo multi-day transport in ambient temperature and yielded comparable smear and Xpert results to the SOC group.
Novel multi-day sputum transport reagent works with routine tuberculosis tests and eliminates need for cold chain: Preliminary study of compatibility with the Xpert MTB/RIF assay. Contact us at infectious.disease@dnagenotek.com for a copy.
- Kelly-Cirino et al. 2016, Diagnostic Microbiology & Infectious Disease
This study assessed the performance of OMNIgene•SPUTUM-treated sputa following both of the manufacturer-recommended specimen processing protocols for the GeneXpert assay. Fifty-five characterized sputa from FIND’s TB Specimen Bank were investigated at National Jewish Health (Colorado, USA). Compatibility of OMNIgene•SPUTUM was assessed using the Sputum Sediment protocol (n=25) and the Expectorated Sputum protocol (n= 30). All controls were prepared using the Expectorated Sputum protocol.
Results were 100% concordant for all except the low-positive samples in the Sputum Sediment study arm (n = 10; 88% concordance). This preliminary study showed that OMNIgene•SPUTUM performed well in both protocols.
FIND evaluates OMNIgene•SPUTUM
FIND has initiated a formal evaluation of OMNIgene•SPUTUM in Peru and Ethiopia. This work started in August 2016 and is expected to finish in early 2017. The study is a technical evaluation of the impacts of OMNIgene•SPUTUM on sputum contamination and positivity rates in the two countries. Various times and temperatures will be assessed, as well as compatibility with gold standard diagnostic tests, including MGIT culture, solid culture, smear microscopy and Xpert. FIND will also do a field-based cost assessment that compares the relative costs of OMNIgene•SPUTUM to the current workflow in both countries. Data are expected to be submitted to the World Health Organization for review in early 2017.
Like to Get Started Testing this Product? We are available with support to guide your TB program or laboratory in testing OMNIgene•SPUTUM. Should you have any questions or want to know more about the reagent, please feel free to contact us at infectious.disease@dnagenotek.com.
OMNIgene•SPUTUM is registered as an FDA class one general purpose reagent for laboratory use in the US.