The Gold Standard in HbA1c and Immunoassay
NGSP-certified HPLC technology delivers the most precise HbA1c results available, now at 50 seconds per sample with the FDA-cleared GR01. Paired with the AIA-CL chemiluminescent immunoassay platform offering 50+ assays in unit-dose format — the complete Tosoh solution for Caribbean laboratories.
50 Seconds
Fastest HbA1c HPLC on the market
50 sec
HbA1c Results
Fastest in class
72/hr
GR01 Throughput
2x faster than G8
1.1%
CV Precision
NGSP gold standard
33
Caribbean Territories
Full service coverage
GR01: The Fastest HbA1c Analyzer on the Market
Non-porous ion exchange HPLC delivers gold standard precision at unprecedented speed. FDA 510(k) cleared January 2025 (K250073).
- 50-second HbA1c results — fastest HPLC analyzer on the market
- CV of 1.1% (NGSP) — gold standard analytical precision
- Automatic HbS, HbC, HbD, HbE variant flagging — no manual review
- NGSP / DCCT / IFCC certified — meets every global reporting standard
- Compact 21"W x 20"H x 24"D footprint — fits existing benchtop space
- Trackline and automation ready — scalable to full lab automation
- Automatic buffer change — uninterrupted workflow, no operator intervention
Up to 72 Samples per Hour
At 50 seconds per sample, the GR01 processes up to 72 HbA1c samples per hour — nearly double the throughput of the G8 it replaces. For high-volume diabetes clinics and reference laboratories, this means faster turnaround and higher daily capacity.
HbA1c Cost Economics That Change the Conversation
Reagent cost per test is the single biggest driver of HbA1c program economics. HPLC is dramatically cheaper than immunoassay POC.
HPLC (Tosoh GR01)
$1.50 - $2.00Non-porous ion exchange HPLC — gold standard method, lowest cost per test
per test reagent cost
Boronate Affinity
$3.00 - $5.00Mid-range method — acceptable precision, moderate reagent costs
per test reagent cost
Immunoassay POC (DCA Vantage)
$8.00 - $12.00Point-of-care convenience — but at 4-8x the per-test reagent cost of HPLC
per test reagent cost
Annual Savings at Scale: The GR01 Advantage
Based on 50 tests/day, 260 working days/year = 13,000 HbA1c tests annually.
GR01 Annual Cost
$19,500 - $26,000
13,000 tests x $1.50-$2.00/test
POC Immunoassay Cost
$104,000 - $156,000
13,000 tests x $8.00-$12.00/test
Annual Savings vs POC
$78,000 - $130,000
Per year, every year — with superior precision
5-year impact: Switching from POC immunoassay to GR01 HPLC saves $390,000 - $650,000 in reagent costs over five years — while delivering superior CV of 1.1% precision that meets every accreditation standard. The instrument pays for itself in months, not years.
GR01 vs. G8: The Next Generation
Same gold standard HPLC method. Twice the speed. Automatic variant flagging. A seamless upgrade for every G8 site.
| Specification | GR01 (New) | G8 (Legacy) |
|---|---|---|
| Time per Sample | 50 seconds | 96 seconds (1.6 min) |
| Throughput | 72 samples/hr | 37 samples/hr |
| Variant Flagging | Automatic (HbS/C/D/E) | Manual interpretation |
| Footprint | Compact (21"W x 20"H x 24"D) | Larger footprint |
| FDA 510(k) | Cleared January 2025 | Cleared (legacy) |
| HPLC Method | Non-porous ion exchange | Non-porous ion exchange |
| NGSP Certified | Yes | Yes |
| Buffer Change | Automatic | Manual |
AIA-CL: Chemiluminescent Immunoassay Platform
Unit-dose CL AIA-PACK technology: one cup = one test. Zero reagent waste. From 30 to 240 tests/hr with a single, scalable platform.
AIA-CL300
The entry point to next-gen chemiluminescent immunoassay. 30 tests/hr with a compact 52cm width — fits anywhere. 15-minute first result. 90-day calibration stability means fewer repeats and lower QC costs.
AIA-CL1200
120 tests/hr with 84 sample positions and 43 reagent positions. Evoline automation ready for walk-away operation. The workhorse for hospital and reference laboratories.
AIA-CL2400
240 tests/hr with 200 sample positions and 1,280 test cups on board. Full lab automation integration. Maximum throughput for reference laboratories and large hospital systems.
50+ Immunoassay Parameters, One Platform
From thyroid function to tumor markers, the AIA-CL menu covers the breadth of hospital immunoassay testing.
Thyroid
5 assaysTSH, FT4, FT3, TT4, TT3
Cardiac
3 assaysTroponin I, CK-MB, Myoglobin
Tumor Markers
5 assaysPSA, CEA, AFP, CA19-9, CA125
Fertility
6 assaysBeta-HCG, FSH, LH, Estradiol, Progesterone, Testosterone
Diabetes
2 assaysInsulin, C-Peptide
Anemia
3 assaysB12, Folate, Ferritin
Bone Metabolism
1 assayPTH (Intact)
Kidney
2 assaysCystatin C, Beta-2 Microglobulin
All assays available in unit-dose CL AIA-PACK format. One cup = one test. No bulk reagent waste. Full menu compatibility across CL300, CL1200, and CL2400 platforms.
Classic AIA: Proven Unit-Dose Immunoassay
The original AIA platform — decades of proven reliability with patented unit-dose AIA-PACK technology. From benchtop clinics to high-volume hospital labs.
AIA-360
36 tests/hr with 25 sample positions. Compact benchtop format ideal for physician office labs and small clinics with low-to-moderate immunoassay volumes.
AIA-900
90 tests/hr with 100 sample positions and automatic dilution. Reliable mid-volume immunoassay for community hospitals and multi-specialty clinics.
AIA-2000
200 tests/hr with 960 test cups on board and 4-hour walk-away time. High-throughput immunoassay with proven unit-dose technology.
G8 and G11: The Foundation of HPLC Excellence
The analyzers that defined gold standard HbA1c testing. Both platforms offer a clear upgrade path to the GR01.
G8 HPLC
The G8 set the standard for HPLC-based HbA1c analysis with 37 samples/hr, a 290-sample loader, and rock-solid NGSP certification. Now succeeded by the GR01 with 2x faster throughput.
G11 HPLC
120 samples/hr with 30-second standard mode. Three analysis modes: Standard HbA1c, Variant, and Beta-Thalassemia screening. Advanced hemoglobin analysis in a single platform.
Why Tosoh + Caribbean Diagnostics
A world-class analyzer platform backed by a regional partner who installs, trains, services, and supports — already in your territory.
In-Region Field Engineers
Caribbean-based biomedical engineers provide same-week response for installations, preventive maintenance, and break-fix service. No waiting weeks for a mainland technician.
Factory-Backed Support
Direct escalation path to Tosoh Bioscience global service engineering. Level-3 support for complex instrument issues resolved with factory expertise.
Unit-Dose = Zero Waste
AIA-PACK and CL AIA-PACK unit-dose test cups mean one cup = one test. No bulk reagent bottles to expire. Ideal for island labs with variable daily volumes.
50+ Years of Tosoh Heritage
Tosoh Bioscience has manufactured HPLC columns and immunoassay systems for over five decades. The GR01 and AIA-CL represent the latest generation of proven technology.
Unit-Dose: Built for Island Labs
Island laboratories face unpredictable daily volumes. A hurricane week might mean zero tests; the following week might triple normal volume. Tosoh's unit-dose AIA-PACK and CL AIA-PACK technology is uniquely suited to this reality: you use only what you need. No bulk reagent bottles expire on the shelf. No waste. No panic reorders.
Combined with 90-day calibration stability on the CL300, your lab stays ready without constant recalibration — even during low-volume periods.
Ready to Upgrade Your HbA1c or Immunoassay Platform?
Whether you are replacing an aging G8, evaluating the GR01 for a new HbA1c program, or scaling your immunoassay menu with the AIA-CL platform — our team will assess your workflow, model the cost savings, and design a solution tailored to your laboratory.
Caribbean Diagnostics is an authorized Tosoh Bioscience distributor serving 33 Caribbean territories with in-region field engineers, factory-backed service, and 17+ years of island laboratory expertise.