BioHealth- Hormone Saliva Test Stability- Study-Paper

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Presentation Description

In the market, there are several tests for hormone imbalance but when it’s about stability of the given samples for hormone imbalance test which works well. It’s a tricky question for patients and practitioners as well. A simple solution is saliva testing. The stability of saliva tests are prolonged more than other tests.

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BioHealth Laboratory | 23900 Hawthorne Blvd 150 Torrance CA 90505 800-570-2000 USA/Canada | 307-212-6600 | www.biohealthlab.com The Stability of Saliva for Hormone Testing: A Pilot Study There are multiple options in the functional medicine marketplace for the testing of salivary hormone analytes. But how do you know which one is giving you the accuracy and precision your patients deserve Certainly working with a proven specimen type like saliva is important but we also need to look at the temperatures required to maintain a quality patient specimen. Salimetrics www.salimetrics.com considered to be the world leader in salivary bioscience research recommends that all saliva samples be stored promptly at extremely cold temperatures -20C for maximum stability. Although they admit that this is a conservative position the research standard they recommend saliva be kept as cold as possible because they’ve observed that the closer to frozen a specimen stays the better the preservation of the analytes and the more accurate the results. For example after several days at ambient temperatures Salimetrics studies have shown DHEA not DHEA-Sulfate the more stable form tested by BioHealth results in a deviation from baseline by 52. The same ambient exposure conditions for estradiol resulted in a 36 deviation from baseline. Having your patients use test kits that do not require cold storage and expedited shipping is a source of major concern given how some hormones degrade and cause inaccurate results. In order to determine the efcacy of diferent packaging and shipping methods used in functional medicine BioHealth conducted the following experiment on progesterone and testosterone using real-world shipping conditions. Progesterone is well-known to be unstable unless preserved while testosterone is reputed to be more stable. Hormones such as cortisol and DHEA-S were omitted from the study due to their proven stability at ambient temperatures. As you’ll see BioHealth is the only lab that insists on cold preservation of samples and specifc handling steps to preserve the integrity of sensitive hormone analytes and the subsequent patent test results. Experiment Model 1. Test kits were obtained from 5 of the major functional medicine labs who perform salivary hormone analysis. Shipping and Packaging Methods a. Lab 1 BioHealth: Vials are frozen and shipped overnight on a large cold pack with AM delivery b. Lab 2: Vials are stored at ambient temperature and shipped by standard overnight delivery. No ice packs are used. c. Lab 3: Vials are stored at ambient temperature and sent by 2-day delivery. No ice packs are used. d. Lab 4: Vials are stored at refrigerated temperatures and sent 3-day select. No ice packs are used. e. Lab 5: Vials are stored at ambient temperature and sent by Ground methods. No ice packs are used. f. Lab 6: Vials are frozen for at least 2 hours and sent priority overnight. No ice packs are used.

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BioHealth Laboratory | 23900 Hawthorne Blvd 150 Torrance CA 90505 800-570-2000 USA/Canada | 307-212-6600 | www.biohealthlab.com 2. Instructions for collection and shipping were followed precisely according to each lab’s patient test instructions. In addition to saliva samples a USB temperature logger was validated then included in each kit. 3. Kits were sent from the central United States by the method required by each lab respectively to a mail forwarding service located near each lab then sent to BioHealth. 4. The temperature fuctuations each package was subjected to were emulated by programming the time intervals and temperatures recorded by the temperature loggers into a series of digital incubators. 5. 38 volunteers donated saliva specimens which were aliquoted then subjected to each lab’s respective collection and shipping conditions as well as a sample that was tested immediately to provide a baseline for comparison. 6. After the time interval of the applicable environmental conditions transpired each sample was tested and compared to the baseline test. Temperature Fluctuations during Transit We found that most labs’ shipping and handling methods subjected samples to extreme swings in temperature. We believe much of this is due to time in delivery vehicles where climate control is non- existent and inferior packaging does not keep samples cold and in many cases not even cool. Observed temperatures from other labs ranged from a low of 48°F to a high of 109°F. Using the data loggers we observed multiple rises and falls in samples temperature between time of shipping and arrival at our lab. We believe these swings are a major contributing factor to compromised stability. In contrast when we looked at the temperatures recording during the travel of a BioHealth test kit we found great consistency. During the journey the temperature inside the kit stayed between 35°F and 41°F degrees Fahrenheit. It is also important to note that only BioHealth requires the patient to freeze their samples before shipping. The process of freezing saliva as soon as possible serves to inhibit bacterial growth and also precipitates mucins in the sample in order to improve the pipetting procedure and accuracy at the lab. Summary of Results Progesterone Progesterone is an endogenous steroid and progestogen sex hormone involved in the menstrual cycle pregnancy and embryogenesis. It has broad reaching efects and is a critical measurement in mapping the female cycle determining dosages of HRT and understanding the cause of many female hormone related dysfunctions. While BioHealth’s shipping methods resulted in an average of 88 recovery of baseline results other labs’ shipping and handling methods did not fare as well as seen in the following list of results:

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Lab 1 BioHealth Lab: 88 recovery to baseline samples Lab 2: An average of 50 recovery of baseline samples Lab 3: An average of 37 recovery of baseline samples Lab 4: An average of 55 recovery of baseline samples Lab 5: An average of 48 recovery of baseline samples Lab 6: An average of 70 recovery of baseline samples Testosterone Because salivary testosterone has a more specifc narrow testing range for its quality control standard solutions large changes in measurement correspond to signifcant deterioration of the sample. Therefore it is best to examine testosterone in the context of the clinically signifcant percentage change from baseline result in order to see the degradation of samples during transit. In many salivary hormone stability studies the standard is to consider any result that isn’t within 15 of the baseline to be a failure. For every 10 samples 8 80 should be within 15 of baseline to be considered stable. This criterion puts patient safety frst emphasizing concise data for interpretation and possible treatments. What we saw in our experiment is that only BioHealth’s packing and shipping methods led to a result that would be considered a success. Lab 1 BioHealth: 81 of all samples within 15 of baseline samples Lab 2: 39 of all samples within 15 of baseline samples Lab 3: 42 of all samples within 15 of baseline samples Lab 4: 58 of all samples within 15 of baseline samples BioHealth Laboratory | 23900 Hawthorne Blvd 150 Torrance CA 90505 800-570-2000 USA/Canada | 307-212-6600 | www.biohealthlab.com

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Lab 5: 61 of all samples within 15 of baseline samples Lab 6: 58 of all samples within 15 of baseline samples Final Words Sending saliva samples for progesterone and testosterone testing by any method in which samples were not required to be frozen before being shipped overnight at refrigerated temperatures resulted in discrepancies that could result in inaccurate test results and misguided decisions for interpretation and treatment. While this study was fairly small we believe it is an accurate representation of the results of erratic and poorly controlled transit variables on progesterone and testosterone. There are analytes that need to be shipped as cold as possible to ensure accuracy. In the future BioHealth will be running similar tests and expanding the number of analytes tested. In the meantime our commitment to putting discernable accuracy above shipping costs will remain unchanged. BioHealth Laboratory | 23900 Hawthorne Blvd 150 Torrance CA 90505 800-570-2000 USA/Canada | 307-212-6600 | www.biohealthlab.com

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