Product Overview
The Tosoh AIA-PACK® immunoassay reagent system provides a broad menu of clinical immunoassays in single-unit, dry-reagent test cups. Each barcoded test cup contains the assay-specific reagents required for analysis, eliminating test-cup premixing and premeasuring.
The AIA-PACK format is used across the AIA-360, AIA-900 and AIA-2000 platforms. This common reagent format can help laboratories coordinate inventory and testing across compatible Tosoh AIA systems.
The current U.S. menu includes 46 assays covering thyroid, cardiac, reproductive, tumor-marker, metabolic, diabetes, kidney, anemia and additional specialty testing. Most assays use a 10-minute incubation protocol, while selected assays require additional pretreatment or incubation and are not available on the AIA-360.
46 Current Assays
A broad menu covering nine clinical testing categories.
10-Minute Incubation
Most AIA-PACK assays use a 10-minute incubation protocol.
One Reagent Format
Designed for compatible AIA-360, AIA-900 and AIA-2000 workflows.
AIA-PACK Unit-Dose Reagent Technology
- Single-unit test cups: Each cup contains the assay-specific dry reagents needed for one test.
- No test-cup preparation: AIA-PACK test cups require no premixing or premeasuring.
- No onboard refrigeration: Test cups do not require refrigeration while loaded on the analyzer. Product storage requirements remain assay specific.
- Barcoded identification: Barcodes support test identification, scheduling and reagent inventory management on compatible systems.
- Extended calibration stability: The dry-reagent format provides calibration stability of up to 90 days for most assays.
- Shared AIA format: Compatible reagents use the same test-cup format across the Tosoh AIA analyzer family.
- Broad testing menu: The current U.S. menu includes routine and specialty assays across nine clinical categories.
- Biotin-free designs: Tosoh’s current U.S. menu describes the AIA assays as using biotin-free immunoassay designs.
Incubation time is not the same as total result time. Complete processing time depends on the assay, analyzer and laboratory workflow.
Current Tosoh AIA Immunoassay Menu
The following menu is based on Tosoh’s current 2024 U.S. AIA Test Menu.
Tumor Markers
- AFP
- CEA
- PA
- 27.29
- CA125
- CA19-9
Reproductive
- βHCG
- HCG
- DHEA-S
- E2
- FSH
- LH II
- PRL
- PROG II
- PROG III
- SHBG
- Testosterone
Thyroid
- TSH
- TT3
- T4
- FT3
- FT4
- T-U
- TSH 3rd-Gen†
- TPOAb†
- TgAb†
Cardiac Markers
- BNP*
- CK-MB
- cTnI 2nd-Gen
- Myoglobin
Metabolic
- CORT
- HGH
Kidney Markers
- BMG
- Cystatin C
- Intact PTH
Anemia
- FER
- B12†
- Folate†
- RBC Folate†
Diabetes
- C-Peptide II
- IRI (Insulin)
Additional Assays
- ACTH
- Homocysteine
- IgE II
- PAP
- 25-OH Vitamin D†
† Requires more than 10 minutes for pretreatment and/or incubation and is not available on the AIA-360.
* Tosoh identifies BNP for Emergency Department use. Laboratories must follow the current product labeling and applicable testing requirements.
Compatible Tosoh AIA Analyzers
The AIA-PACK test-cup format supports Tosoh AIA systems designed for different laboratory volumes and workflows.
Tosoh AIA-360
Compact random-access immunoassay analyzer with throughput up to 36 tests per hour. Selected assays requiring additional pretreatment or incubation are not available on this model.
Tosoh AIA-900
Continuous random-access immunoassay analyzer with throughput up to 90 tests per hour and multiple loading configurations.
Tosoh AIA-2000
High-volume continuous random-access immunoassay analyzer with throughput up to 200 tests per hour.
Reagent System Details
| Product Family | Tosoh AIA-PACK® immunoassay reagents |
|---|---|
| Format | Single-unit, dry-reagent test cups |
| Compatible Analyzer Family | Tosoh AIA-360, AIA-900 and AIA-2000; assay compatibility varies by model |
| Current Menu | 46 assays across nine clinical testing categories |
| Incubation | 10 minutes for most assays; selected assays require additional time |
| Calibration Stability | Up to 90 days for most assays |
| Test-Cup Preparation | No test-cup premixing or premeasuring |
| Onboard Refrigeration | Not required for AIA-PACK test cups; follow assay-specific storage instructions |
| Identification | Barcoded test cups for assay identification and inventory management |
| Supporting Products | Assay-specific calibrators, controls, common reagents and consumables |
Documentation and Resources
Review the current Tosoh AIA assay menu, then contact Jant Pharmacal to confirm reagent availability, analyzer compatibility, calibrators, controls, common reagents and ordering requirements.
Important Product Information
- Assay availability, pack size and ordering information may change. Confirm current availability with Jant Pharmacal before ordering.
- Not every assay is available on every Tosoh AIA analyzer. Assays marked with a dagger in the current menu are not available on the AIA-360.
- Specimen type, sample volume, calibration, quality-control requirements, measuring range, storage conditions and reference intervals are assay specific.
- CLIA complexity and regulatory status apply to the individual assay rather than to the AIA analyzer family as a whole.
- Use only reagents, calibrators, controls, common reagents and consumables specified in the current Tosoh instructions for the applicable analyzer and assay.
- Testing must be performed by appropriately trained laboratory personnel according to the current instructions for use and the laboratory’s validated procedures.
Frequently Asked Questions
AIA-PACK reagents are single-unit dry-reagent test cups designed for compatible Tosoh AIA automated immunoassay systems. Each barcoded cup contains the assay-specific reagents required for one test.
The AIA-PACK format is used with the Tosoh AIA-360, AIA-900 and AIA-2000 systems. Individual assay availability varies by analyzer, and selected assays are not available on the AIA-360.
The current 2024 U.S. test menu lists 46 assays across tumor markers, reproductive testing, thyroid, cardiac markers, metabolic, kidney markers, anemia, diabetes and additional specialty testing.
Most AIA-PACK assays use a 10-minute incubation protocol. Selected assays require additional pretreatment or incubation. Total time to result also depends on the assay, analyzer and laboratory workflow.
The unit-dose test cups require no test-cup premixing or premeasuring. Laboratories must still prepare specimens and supporting products according to the current assay instructions.
AIA-PACK test cups do not require onboard refrigeration. Storage conditions before loading, expiration requirements and handling instructions remain assay specific and must be taken from the current product labeling.
Tosoh states that the dry-reagent format provides calibration stability of up to 90 days for most assays. Calibration requirements and stability must be confirmed for the specific assay and reagent lot.
No. Assays identified by Tosoh as requiring more than 10 minutes for pretreatment or incubation are not available on the AIA-360. These include TSH 3rd-Gen, TPOAb, TgAb, B12, Folate, RBC Folate and 25-OH Vitamin D in the current menu.
Yes. Jant Pharmacal can help confirm the current assays, calibrators, controls, common reagents and consumables required for the laboratory’s AIA analyzer and planned test menu.
Ordering Information
To confirm current reagent availability, analyzer compatibility, calibrators, controls, pack sizes or pricing, call Jant Pharmacal at 800.676.5565
When requesting information, please provide the laboratory’s Tosoh AIA analyzer model, planned assay menu and estimated testing volume.