Equipment for Immunoassay

IMMUNOASSAY - BASIC CONCEPT

The technology of Lateral Flow Immuno-Assay (LFIA, or strip test) has been around for years with continuing widespread usage in various sectors. A number of variations of the technology have been developed into commercial products, one of which is called Rapid Test device.

RAPID TEST DEVICE - COMPONENTS

A rapid test device is typically comprised of a test strip inside a plastic housing (cassette or kit). A typical test strip consists of the following materials (components) where 1 through 5 is fixed onto the plastic backing for support:

  • 1. Sample pad
  • 2. Conjugate pad
  • 3. Membrane
  • 4. Absorbent pad
  • 5. Top cover tape (optional)
  • 6. Plastic backing

RAPID TEST DEVICE - TEST ITEMS

Among the wide spectrum of applications available on the market, some of the more common rapid test devices are as follows: For various diseases such as hepatitis A, B, and C, AIDS, malaria, etc., drug of abuse (DOA), pregnancy, ovulation, and various types of cancer.

PRODUCTION PROCESS & EQUIPMENT - For Mfg. Immunoassay Rapid Test Device

Following charts describe a typical production procedure for automated and batch (scaled-down) production method. They have been outlined to give you a general understanding of how the process works and the applicable equipment at each of the production stage.


STAGE AUTO PROCESS PROCESS DETAILS APPLICABLE EQUIPMENT
1 Reagent Treatment 1 Dispensing reagent lines onto membraneto produce treated MEMBRANE roll DAI-System
2 Reagent Treatment 2 Impregnating pads by dipping, drying, (and splitting)to produce treated CONJUGATE / SAMPLE PAD roll OASI-300OAI-300
3 Lamination Lamination of required materials onto support backingto produce master (finished) card LAI-Series
4 Assembly Inserting test strips into cassettes with QC inspectionto produce individually assembled test device SAIA-210AIB-300
5 Packaging Packaging the test device and other accessories to produce a final product in a sealed pouch Custom Equipment
STAGE BATCH PROCESS PROCESS DETAILS APPLICABLE EQUIPMENT
1 Lamination 1 Lamination of MEMBRANE onto support backing card*Absorbent pad can also be laminated LCC-100 LCI-Series
2 Reagent Treatment 1 Dispensing lines onto membraneto produce treated MEMBRANE DCI-SystemDMI-System
3 Reagent Treatment 2 Impregnating pads (manually)to produce treated CONJUGATE / SAMPLE PAD sheets ODI/U-000
4 Drying Drying of treated membrane and pad materials OVD-151/2OHD-105/155
5 Slitting Slitting of sheets into narrow width (CONJUGATE / SAMPLE / ABSORBENT PAD)to produce laminatable pre-cut strips GSI-600RSI-400
6 Lamination 2 Lamination of pre-cut strips and other materials onto backing card (CONJUGATE / SAMPLE PAD, TOP TAPE) to produce master (finished) card LCC-100LCI-Series
7 Cutting Cutting of master card to produce individual test strips GCI-800RCI-300RAI-500
8 Assembly Manual assembly of test strips and cassettes to produce individually assembled test device ACC & ACP-100
9 Packaging Packaging the test device and other accessories to produce a final product in a sealed pouch OBS-115

*The listed order of process is of the more common procedure in most cases. The actual sequence, however, may vary depending on operator’s preference and other factors such as items produced, QC measures, and etc.



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