At-Home A1c Test Kit
Call Us: +1.888.872.2443
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.
Test results reporting: Secure website lab results reporting (client is assigned a secure username 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/18/18/14.
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
CLIA/FDA/CMS licensed.
Video demonstration of kit available at dtilaboratories.com (A1c Video link)
Technical support: 24/7 toll free line: 888.872.2443
Delivery time: typically 2 days from receipt of payment.
Accuracy: CV's < 2.0%.
Lab turnaround time: Typically <48 hours from receipt of test.
Private labeling is available
Comprehensive Secure web based services
TLS secure transmissions on email
Programming API for pre enrollment, order fulfillment and real time data reporting
OTC Approved
$50.95 including shipping
National Glycohemogobin
Standardization Program Certified Method
The DTIL A1c Test Kit is a non-fasting, finger stick, whole blood mail-in test. It is considered the most accurate and comprehensive at-home A1c test available. This is not a Dried Blood Spot (DBS) test. DBS mail-in tests are known to have temperature, humidity and transport problems. The DTIL test is considered sensitive and specific enough to detect or screen for diabetes. Unlike LDT methods and kits, we are FDA cleared.
The American Diabetes Association (ADA) recommends that A1c samples be screened for abnormal hemoglobin's as part of the screening and/or diagnosing process. DTI Laboratories is not a collection station and does not use partner laboratories to process your sample. We are a national core laboratory that provides exclusive testing for all our samples.
The DTIL A1c Test is the only A1c test that screens for abnormal hemoglobin's using HPLC-IE. Abnormal hemoglobin's are known to cause interferences in A1c results. DBS mail-in A1c tests are incapable of detecting
abnormal hemoglobin's.
DTIL has successfully participated in the College of American Pathology (CAP) GH2 survey for over 20 years. The DTIL A1c Test Kit does not require any drying time, samples can be collected and mailed within minutes. The kit comes complete with positive patient identification, EDTA sample vial (preserves the sample), capillary tube device for ease of accurate sample collection, pre-addressed postage paid return mailer with USPS tracking number. Typical mailing time to the participant is only 2-3 days.
Our analytical method uses HPLC-IE method which is approved for diabetes screening. Samples are stable for 21 day un-refrigerated once collected. Each test result comes with an estimated Average Glucose (eAG) calculation based on the DCCT Equation: % A1c X 28.7 - 46.7 = eAG in mg/dl. Test results are typically available within 3 to 4 days from mailing.
Kits are available in either English or Spanish and can be private labeled. Patients can receive a copy of the test results multiple ways. Electronic outcomes are available on our secure website.
Proficiency Testing by the
Price include USPS Fist Class Parcel, with Tracking Number.
Tracking Notification is sent via email when kit ships.
Pricing:
$50.95 each
For distributor or wholesale pricing: Please call for quotation. 888.872.2433
Each kit includes:
Components required to collect and mail 1 A1c blood sample
Postage Paid/Pre-Addressed Return Mailer with USPS Tracking Number on label
Laboratory Analysis
Laboratory reporting at secure website: mya1cresults.com/login.php
Access to educational materials
Major Credit Cards Accepted.
CPT Medicare code 83036
FDA approved for over the counter (OTC) use
CLIA Approved Laboratory/NGSP Certified Method of analysis
Only FDA approved Mail-In A1c Test Kit
Reportable test range: 3.8% - 19.6%
Test results are reviewed by a Board Certified Clinical Pathologist.