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FAQs
General Biosafe - FAQsWho is Biosafe?
Why use Biosafe's test kits?
Are the Biosafe tests FDA approved?
What does taking a Biosafe test entail?
Can any disease be contracted or transmitted with the dry spot collection method?
Do I need to order kits in the future?
Does the Biosafe collection kit have an expiration period (or date)?
How do Biosafe's test results compare to what I might get from my doctor?
How long does it take to get my lab results?
How old does a person need to be to take Biosafe's laboratory tests?
I am not getting enough blood from my finger, what can I do?
Is fasting required before a blood sample is collected for any of the Biosafe tests?
Is mailing my blood sample safe?
What if I want to talk with someone about my lab results?
Will the results of my test be sent to me, my doctor or both?
Why is my Biosafe test result different from the last one I took in my doctor's office?
Are the Biosafe test kit instructions available in other languages?
Who is Biosafe?
Why use Biosafe's test kits?Biosafe is one of the leaders in medical diagnostic test kits for at home or in office use. Each of Biosafe's test kits has been FDA approved, and all tests are processed at the Biosafe CLIA (Clinical Laboratory Improvement Amendments) approved laboratory to insure the accuracy of the results. Biosafe has designed each of its test kits so that they are easy enough to be self-administered, thus allowing you to use the test kit in the privacy of your home or office. Simply take a test sample, mail the sample to the Biosafe laboratory (pre-paid return mailer included with kit). Within 72 hours of receiving your sample, Biosafe will contact you with your results.
(Source Biosafe 2004)
Are the Biosafe tests FDA approved?The BIOSAFE Blood Collection Kit is composed of FDA approved components. However, the FDA does not regulate testing for clinical laboratories. That is a function of Clinical Laboratory Improvement Amendments (CLIA).
In order to receive and maintain a CLIA certification, a clinical laboratory must be continually inspected and certified by a CLIA approved inspection body.
CLIA certification requires a laboratory to have protocols for test methods, performance specifications, test report requirements and maintenance of patients' reports.
The BIOSAFE Laboratory is a fully CLIA certified clinical laboratory.
(Source Biosafe 2004)
What does taking a Biosafe test entail?Each test is slightly different, but basically the specimen collection process is quick, easy and virtually painless. Using the special lancet (included in the Biosafe Blood Collection Kit), a couple of drops of blood are taken from a nick of a finger and deposited into a special collection device called a BTS (Blood Transport System) or onto a special sample card. The sample is then sent to Biosafe Laboratories for analysis. Biosafe tests your blood sample and then mails the results back to you in an easy-to-read, understandable report.
For test specific procedures, look at the information section of each test.
(Source Biosafe 2004)
Can any disease be contracted or transmitted with the dry spot collection method?If person's taking the test follow the simple enclosed instructions, they are at NO risk of receiving any transmittable disease from taking a sample with the BIOSAFE Blood Collection Kit.
The personnel in our laboratory follow Universal Precautions when handling blood products, so their risk of contracting blood borne pathogens is extremely low.
(Source Biosafe 2004)
Do I need to order kits in the future?Keeping aware of your body's condition requires routine checking. Some tests should be run every quarter while others should be done annually. Look at each specific test for testing frequency recommendations.
(Source Biosafe 2004)
Does the Biosafe collection kit have an expiration period (or date)?Yes, the kits have expiration dates. Check the label on the Blood Sample Return Pouch for the expiration date. Although highly unlikely, if you happen to receive a Collection Kit that has expired, please call our customer service at 888-700-TEST(8378), and Biosafe will issue you a new kit immediately.
(Source Biosafe 2004)
How do Biosafe's test results compare to what I might get from my doctor?Biosafe's dry blood spot values are equal to serum and/or whole blood values found in numerous clinical studies. Patient results from one lab to another cannot be directly compared because different labs use different methods for testing, which can cause variations in results.
(Source Biosafe 2004)
How long does it take to get my lab results?Simply take a test sample, mail the sample to the Biosafe laboratory (pre-paid return mailer included with kit). Within 72 hours of receiving your sample, Biosafe will contact you with your results.
(Source Biosafe 2004)
How old does a person need to be to take Biosafe's laboratory tests?Appropriate age is up to the discretion of the physician or parent if the person is under 18 years of age. Some of the Biosafe tests are recommended for a specific gender, age or risk group. Please follow the guidelines in the specific product section of this site.
(Source Biosafe 2004)
I am not getting enough blood from my finger, what can I do?First, evaluate your technique. It is important to follow the instructions in the Blood Collection Kit. To ensure a proper sample, follow these suggestions: wash your hands with warm water, choose an area slightly off center on the finger to be nicked (this will produce a better blood flow), and rub you hands together for 10 seconds and allow your arm to rest at your side for 30 seconds. Standing may also help blood flow.
We include two lancets with every kit, so if you do not get an adequate sample from the first finger nick you may still use the second lancet on another finger.
(Source Biosafe 2004)
Is fasting required before a blood sample is collected for any of the Biosafe tests?The BIOSAFE Total Cholesterol Panel is the only test that requires a fast before blood sample collection. In order to compute an accurately calculated LDL cholesterol value for this test, the triglyceride level must be what is called a "fasting level." Triglyceride levels are related to the time you ate and when you collected the sample.
Fasting should begin 12 to 14 hours before the sample collection. Only water is permitted to drink during the time of fasting.
No alcohol should be taken 24 hours before sample collection for any of the cholesterol tests, and food eaten at much as 2 weeks before sample collection may still affect results.
A balanced diet three to six months prior to sample collection will provide the most accurate assessment of cholesterol levels.
(Source Biosafe 2004)
Is mailing my blood sample safe?Depending on what type of test you order, each Biosafe test kit comes with either a special device or card used to collect your sample. The device (called the Blood Transport System - BTS) is constructed to self-contain a blood sample, while the collection card is placed into a special sample bag made to contain blood samples. The final step is to place the device or sample bag into a liquid tight pre-addressed and pre-paid First-Class mailer created to protect samples. The mailer is labled "Clinical Specimen - Blood Sample," so the post office is aware of what they are transporting. Each step of the collection and transportation procedure has been designed to insure a safe delivery of blood samples.
(Source Biosafe 2004)
What if I want to talk with someone about my lab results?If you have any questions about your test results, you can call a Biosafe nurse toll-free at 1.888.700.8378 Monday - Friday, 8:00 A.M. to 5:00 P.M. Central Time.
(Source Biosafe 2004)
Will the results of my test be sent to me, my doctor or both?Your results will be mailed directly to you, the consumer, if you are the one purchasing the test. You may also purchase the test for someone else as a gift. The results will then go to that person. If your doctor would also like a copy of your test results, we suggest that you send him/her one, or, if you request it at the time of testing, we will send you an additional copy for your doctor.
(Source Biosafe 2004)
Why is my Biosafe test result different from the last one I took in my doctor's office?Individual laboratories use different methods for testing which can cause slight variations in results. It is always advisable to use the same laboratory for repeat medical testing in order to decrease these possible test variances.
Also, basic body changes, when compared to the time elapsed between tests, can produce significant variations in results.
(Source Biosafe 2004)
Are the Biosafe test kit instructions available in other languages?The Biosafe Blood Collection Kit literature, instructions, and packaging are all written in both English and Spanish. Other languages are not available at this time.
(Source Biosafe 2004)
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