Call Us: +1.888.872.2443
“When A1c Accuracy Counts, Count of DTI Laboratories”
When selecting an A1c method, laboratory or vendor to perform your A1c analysis, several important considerations should come to mind. These include but are not limited to: Assay accuracy, high degree of sensitivity, wide range of linearity (3.0% – 19.7%), low CV’s (<2.0%), precision, reproducibility, achieving CAP proficiency survey targets, FDA approval, CLIA reference laboratory in good standing, comprehensive API and secure web based services capabilities (including access via smart phone or PDA devices), finger stick (capillary) collection, proven history in the clinical/
clinical research diagnostic arena, positive patient ID, outstanding performance characteristics, analytical compensation for the major abnormal hemoglobin variants, ease of use, and home or mail-in testing kits (FDA/OTC approval).
DTILaboratories, Inc., meets all the above requirements plus many other important considerations when choosing
a diagnostic laboratory and test kit for A1c analysis. Please take a few minutes to review the information below concerning our company and our A1c analytical and secure web based capabilities. We are pleased to announce that our laboratory employs the use of the FDA/OTC/CLIA Waived, AccuBase A1c Test Kit for performing A1c analysis.
Regarding your interest in A1c, please find below and attached information concerning our ability to provide state of
the art A1c testing to your company and/or clients.
Our A1c test kit is a finger-stick (capillary) non-fasting mail-in FDA/OTC approved test kit approved for monitoring
and sensitive enough to be used for pre-diabetes and diabetes screening. The kit comes with the components
necessary to collect and mail one (1) A1c test. The blood samples are stable for 21 days from sample collection. Also available is a 50 test screening kit. The kits are stable for 18 months from manufacturing. The kits come complete
with a USPS Pre-paid/Pre-addressed; First Class peel and place return label, with delivery tracking label and number.
Sample size is 5 ul and the blood stabilizing solution is EDTA. Once the sample is combined with the EDTA, the red blood cells are preserved. The analytical method that we use is HPLC-IE. We have been processing these kits for over 15 years and was the first FDA approved OTC mail-in test kit in the US using HPLC-IE. Please see the attached performance data sheet for your review (PDF).
Please visit our video demonstration of the kit, simply go to the above AccuBase A1c Video. Our test kit employs the
use of a 6 x 4 x 1.5 inch mailing box. In addition, we can place a numbered bar-code on the outside of the box so you can assign a specific ID number to the specific subject. All samples come with positive ID so the samples can be tracked and not confused with other samples in
We have a couple of options for you regarding the means of order fulfillment or distribution of the individual kits to
OPTION 1. We can provide you any number of kits that you wish with custom lab forms noting your specific
account. The lab forms can include an automatically calculated CDC body mass index result (provided the client
enters the data or height, weight, gender and waist measurement). See example at the secure website under
ID # 1000213. In this case the kits would be shipped via UPS Ground to your designated location. You can use
the box to mail directly to the individual client. The boxes (kits contain a USPS (with tracking #) pre-address/
postage paid return label that they would use to over label the label you sent to the client. I am attaching a PDF
version of the Instruction for Use (IFU) for your review. Also if you view the demonstration video, you can view
the actual collection procedure. Individual quotation available.
OPTION 2. Using our extensive API capabilities, we can also send the kits for you to your subjects. We would
need their Name and current address. The charge for this fulfillment process fee is subject to current quotation. In
this case, we would notify you of the shipments and identify each subject by sample ID number. You would need to provide the information so we could ship the kits. An excel format would be fine. Name, Address, zip code. We would verify each address prior to shipment and maintain our USPS Tracking number so we could determine the status of
the shipments. We can not guarantee delivery of any US Mail, however the loss rate of USPS tracking kits is
Our current process of mailing/tracking is considered very satisfactory, but nothing is guaranteed by the USPS. We can also provide turn-key order fulfillment as part of our secure web services. This would include your e-mailing us the names and addresses of the individuals that you wish to receive a kit (or in a GUID format). We would enter the subject in our data base and mail a kit using USPS tracking. At the same time, the kit would contain a return mailer and USPS tracking pre-paid label. In this case, you would pay for the kits upfront and we would deplete your inventory based
on actual usage over time. When the samples are received at our testing laboratory, we would perform the analysis
and enter the data on our secure website. At the same time, we would automatically notify you that a sample has
been reported and that it is ready for your viewing at our secure site.
If you wish, we do not need to receive the actual name of the subject as we can simply place specific ID numbers
that assign in the last name field. Once the sample has been received to our lab, we would perform the analysis
and report them to our secure website where you would have a client name and password. Once in the site, you
can view individual and/or daily reports or search by sample ID number in the last name field. Please find below
an example of how you might review the lab report (s) on a daily basis:
We will send you the Sample ID # (s): to your e-mail address: email@example.com
Click on or enter the link: https://www.mya1cresults.com/login.php.
1. Enter the sample ID number: 1000213
2. Enter your password: firstname.lastname@example.org
Click enter to view report
After you have completed this example next:
Enter the Client Daily Report site: https://www.mya1cresults.com/ClientLogin.php
Next: enter your Client Code: NCD
Next enter the password: H3moglobin
Next you can view by selecting a date or search by either ID number or identifier (you must tell us which one use
want to use. The sample ID number is most common you can use the date: March, 5th, 2015.
We will provide you the necessary links and password to our secure website to view, forward or print the test results
for each individual subject.
Logistics for order fulfillment:
lets take a tour of the secure website:
1. Send us the name and address of enrollee to email@example.com. (You can send several at one time if you wish).
2. It is not necessary for the client to provide their name and address on the individual lab form as long as you
provide us with a unique accession number or identifier for each enrollee. We will pre-number the identifier on the
lab form and in that way no demographics is necessary.
3. When we receive the sample, we will run and report to our secure website:
https://www.mya1cresults.com/login.php. We will use the Lab (vial) ID Number as the last name unless you
prefer to use your unique identifier. The next field will be the actual lab report for you to view, print or forward.
4. You can also use our secure client daily report site: https://www.mya1cresults.com/ClientLogin.php to review the
list of completed samples by date for up to 90 days.
Your client log in is: NCD
Your password for this site is: H3moglobin. We will go ahead and set up your account so we can practice some sample data to get familiar with the program.
5. Each day that we receive and report a sample (s), we will notify you via e-mail with the specific vial ID number
(s) for the samples that were run that day.
6. You could than go to the secure web site https://www.mya1cresults.com/login.php. and enter your client code
and your password.
You could also go to the client log-in site to view samples for the past 90 days. https://www.mya1cresults.com/ClientLogin.php enter the client code: NCD and your password H3moglobin (case specific).
We can view an example of the actual lab report and send it to you so you can become familiar with the process.
Each day that we receive a request to ship a kit (s), we will send them by delivery confirmation to the client using
USPS track and confirm first class mail. While we keep a log of all tracking numbers, it does not guarantee that the USPS will deliver the package. In this case if we have tried to deliver the package and the USPS states that they
have lost the package, we will send another package but will not be responsible for the costs associated with the attempted delivery.
Please let us know if we can provide any additional information. We look forward to working with you and wish
you the best of luck in serving individuals with or at risk of having diabetes.
Private labeling: Should you have a specific logo or tag-line for your company, please send me a PDF or JPEG copy so we can place it on your custom lab forms. There is no charge for the custom work. We have a considerable amount of technical data and information surrounding the use of A1c, and will provide more of this information as you feel the time to review.
Product description and IT capabilities
Product description: AccuBase A1c Test Kit
PN: 881001 (1 test kit)
NDC Code: 08141-477-01
FDA approval status: Approved for over the counter (OTC) use.
Kit shelf-life 18 months from DOM
Sample stability: 21 days after collection (un refrigerated)
Sample size 5 ul's
Analytical method: HPLC-IE. We do not accept Venous WB samples at this time.
Test results reporting: Secure website lab results reporting (client is assigned a secure ID and password),
Lab ID forms: Custom design (no extra charge). Can label the forms with you study name and/or omit a location for patient/subject name.
Freight: UPS Ground: typically carton of 100 kits/18/18/18.
Freight method: FOB UPS Ground (unless other instructed).
Kits can also be numbered on the outside of the kits (.50 extra QC charge).
Laboratory: DTI Laboratories, Inc., National Reference Lab specializing in A1c and abnormal hemoglobins,
Price: List $34.95 each
Discounted price for 100 - 500 kits $32.95 plus freight.
Video demonstration of kit available at www.dtilaboratories.com (A1c Video link)
Technical support: 24/7 toll free line: 888.872.2443
Delivery time: typically 4 days from receipt of payment.
Accuracy: lowest CV's in industry < 2.0%.
Lab turnaround time: Typically 48 hours from receipt of test.
Private labeling is available (quote on request)
Comprehensive Secure web based services
TLS secure transmissions on e-mail
Programming API for pre enrollment, order fulfillment and real time data reporting
Orders can be mailed, faxed, phoned or e-mailed to firstname.lastname@example.org.
Shipment time for orders: Typically 1 week from receipt of order.
Fully HIPAA compliant. For additional confidentiality, we can also mask client name based on GUID input.
Sequential numbering of kits: Yes
Non-Fasting test: Yes
Secure website for clients: https://www.mya1cresults.com/Login.php (client will need their sample ID number
and e-mail address)
Secure website for providers:https://www.mya1cresults.com/ClientLogin.php (The Provider will be provided a user name and password).
Thank you for reviewing this information concerning DTI Laboratories, Inc., and the AccBase A1c Capillary Blood CollectionTest Kit.
Our contact information is as follows:
DTI Laboratories, Inc.
PO BOX 1954
Thomasville, GA 31799-1954