Te “B” specimen can be handled as a “B” sample would be in a urine test program. As many similarities as possible were
maintained to minimize laboratory validation requirements between the Quantisal® II and its predecessor, Quantisal® (Table 1). Te same materials (plastics, pad, etc.) were employed to ensure customer safety was not compromised.
Authentic specimens: Oral fluid specimens were collected from known drug users using three different collection procedures in a randomized protocol: 1. Neat, expectorated oral fluid (“spiting”) 2. Quantisal® collection 3. Quantisal® II collection Te samples were analyzed using
immunoassay techniques and LC-MS/MS procedures in the Immunalysis toxicology analytical services laboratory. Te results
Table 1: Comparison between Quantisal® Parameter
Biological sample
Time to complete collection (adequacy indication activation)
Collection volume
Transportation buffer volume Transportation buffer composition
Drug recovery from collection pad(s) Drug stability in storage and transportation
from the Quantisal® II device are shown in Table 2. Regardless of the drug concentration,
the quantitative value between “A” and “B” samples remained within ±15%, indicating excellent correlation for the split sample results. Unopened “B” samples from many
donors remain refrigerated and will be analyzed aſter storage of one year.
Summary: An oral fluid collection device has been developed and patented which allows the simultaneous collection of 2mL of neat oral fluid, equally divided and absorbed onto two separate collection pads. Te pads are then separated and placed into individual transportation tubes containing stabilizing buffer for laboratory analysis. Tis is the first commercial device to provide a sample collection device for a truly split
and Quantisal® II. Quantisal® Neat oral fluid 3–5 min (50 subjects)
1mL ±10% 3mL
Quantisal® buffer >80% all drugs
(tested near the proposed SAMHSA cutoffs)
Meets proposed guidelines
Table 2: Drug concentrations detected in simultaneously collected oral fluid specimens. Drug THC
Amphetamine Cocaine
Benzoylecgonine PCP
Morphine
6-acetylmorphine Codeine
Hydrocodone Oxycodone
18 datia focus
Methamphetamine 94 70
100 44 66 42 37 17 46
4–1,677 17–4,479 49–23,727 8–51,082 8–36,217 3–2,972 15–2,396 13–2,495 15–648 15–453
30–8,737 Quantisal® II Neat oral fluid 3–5 min (50 subjects)
1mL ±10% on each pad 2 mL total volume
3mL Quantisal® buffer >80% all drugs
(tested near the proposed SAMHSA cutoffs)
Meets proposed guidelines
specimen—one sample for analysis (A) and one for storage (B), with the potential for future testing if required. ❚
Dr. Christine Moore is currently the Vice President of Toxicology Analytical Services for Immunalysis Corporation, an Alere Company. Dr. Moore has
a Ph.D and a Doctor of Sciences (DSc) in Forensic Toxicology from the University of Glasgow (Scotland). She is Board Certified in Toxicological Chemistry, a Fellow of the Royal Society of Chemistry and of the American Academy of Forensic Sciences. Christine is Past-President of the Society of Forensic Toxicologists and the Society of Hair Testing. She has over 110 peer- reviewed publications regarding the analysis of drugs in various biological matrices, including oral fluid.
Specimens tested to date Concentration range (ng/mL) Number of splits ±15% of each other 131 118
131 118 94 70
100 44 66 42 37 17 46
spring 2018
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