Quantitative collection/purification and analysis of saliva analytes in a POC setting

Abstract

Oasis Diagnostics has developed two products to address the need for providing a saliva sample for use in final quantitative analysis of relevant biological analytes in a Point-of-Care (POC) or Point–of-Use (POU) environment. The first product is a real-time quantitative POC/POU Salivary Cortisol test (VerOFy®) that utilizes a fluorescent Lateral Flow Test (LFT) cassette in combination with a Saliva Collection/Purification device. The LFT cassette is then quantitated with a Litebox Image Analysis System (LIAM) which detects the fluorescent bands on the LTF strip. Image Analysis and data transfer is accomplished with an onboard processor, and bluetooth internet data transfer. Each cassette is recognized for test analyte, and lot specific information via QR codes and transferred to the processor on the LIAM. LIAM instrument controls are simple, easy to use, and results are visualized on the onboard screen. The cortisol assay can detect cortisol values in saliva within a standard range of 0.5-15 ng/ml. Total collection and analysis time is approximately 20 minutes. Adequate sample is collected to have remnant sufficient for retain or confirmation. The second product is the Oasis Accu • SAL™ Saliva Collection/Transport device (AS). The AS device was developed to provide an easy to use saliva collection device, which can be placed into a buffer tube, and transported to a lab for analysis of various analytes, including Drugs of Abuse. For transport use, the tube is inverted 4-5 times before shipment. However, the AS can also be used in a POC/POU setting by increasing the number of inversions to insure complete and reproducible extraction and mixing of the saliva sample from the collection pad. The AS has an onboard Sample Volume Adequacy Indicator (SVAI) to signal when collection is complete. Average collection values range from 0.65-1.1 ml, with the overwhelming majority falling between 0.75-0.90 ml. The tube has a volume scale printed on the tube, that can discriminate the volume (+/-20-40ul) remaining in the tube after removal of the collection strip. From that information an accurate volume of saliva collected and the dilution factor can be calculated. The dilution determination is essential in providing accurate values for downstream testing, since the collection volume in this and other saliva collection devices can display wide ranges in recovery depending upon saliva viscosity and other factors.

Full text

Quantitative collection/purification and analysis of saliva analytes in a POC setting.
Robert L. Buck*, Mary J. Laughlin,* Paul Slowey**, Craig Cole*, Chris Slowey**, Casey Buck*,
Tom Hart****, Elizabeth Shirtcliff**,
*=Oasis Diagnostics, 12015 NE Sumner St., Portland, OR. 97220
**=Oasis Diagnostics, 15720 NE 31st Ave, Vancouver, WA 98686
***= Department of Human Development and Family Studies, 4380 Palmer, Suite 2330, Iowa
State University, Ames, Iowa 50011-4380
****Middleton Laboratories, Madison, Wisconsin
Oasis Diagnostics has developed two products to address the need for providing a saliva
sample for use in final quantitative analysis of relevant biological analytes in a Point-of-Care
(POC) or Point–of-Use (POU) environment.
The first product is a real-time quantitative POC/POU Salivary Cortisol test (VerOFy®) that
utilizes a fluorescent Lateral Flow Test (LFT) cassette in combination with a Saliva
Collection/Purification device. The LFT cassette is then quantitated with a Litebox Image
Analysis System (LIAM) which detects the fluorescent bands on the LTF strip. Image Analysis
and data transfer is accomplished with an onboard processor, and bluetooth internet data
transfer. Each cassette is recognized for test analyte, and lot specific information via QR codes
and transferred to the processor on the LIAM. LIAM instrument controls are simple, easy to
use, and results are visualized on the onboard screen. The cortisol assay can detect cortisol
values in saliva within a standard range of 0.5-15 ng/ml. Total collection and analysis time is
approximately 20 minutes. Adequate sample is collected to have remnant sufficient for retain or
confirmation.
The second product is the Oasis Accu•SAL™ Saliva Collection/Transport device (AS). The AS
device was developed to provide an easy to use saliva collection device, which can be placed
into a buffer tube, and transported to a lab for analysis of various analytes, including Drugs of
Abuse. For transport use, the tube is inverted 4-5 times before shipment. However, the AS can
also be used in a POC/POU setting by increasing the number of inversions to insure complete
and reproducible extraction and mixing of the saliva sample from the collection pad. The AS has
an onboard Sample Volume Adequacy Indicator (SVAI) to signal when collection is complete.
Average collection values range from 0.65-1.1 ml, with the overwhelming majority falling
between 0.75-0.90 ml. The tube has a volume scale printed on the tube, that can discriminate
the volume (+/- 20-40ul) remaining in the tube after removal of the collection strip. From that
information an accurate volume of saliva collected and the dilution factor can be calculated. The
dilution determination is essential in providing accurate values for downstream testing, since the
collection volume in this and other saliva collection devices can display wide ranges in recovery
depending upon saliva viscosity and other factors.