How To Setup Lateral Flow Assay Manufacturing Plant?

What is lateral flow test kit?

Lateral flow test kit is a fast diagnostic test kit, one type of POCT, usually based on Immune colloidal gold technique or Immuno fluorescence technique to produce. 

Type of lateral flow test kit

There are hundreds type lateral flow test kit, below list out common rapid test kits:
Typhoid igg/igm test, typhoid ag, malaria pf/pv/ ag test, chagas ab test, chikungunya igm test, dengue ns1 ag test, dengue igg/igm test, leishmania igg/igm test, filariasis igg/igm test, leptospira igg/igm test, tb igg/igm test, toxo igg/igm test, hav igm test, hev igm test, hbs ag test, hcv ab test, syphilis ab test/ hiv 1/2 ab test, hiv ag/ab 4th gen test, saliva hiv test, fob test, rotavirus ag test, adenovirus ag test, cea test, afp test, psa test, troponin I test, ferritin test, influenza A test, influenza B test, H. pylori ag test, H. pylori ab test, cTnI test, CKMB test, Myo test, d-dimer test, NT-proBNP test, LP-pla2 test, crp test, SAA test, pct test, il-6 test kit, fer test kit, VD test kit, FA test kit, hcg test kit, LH test kit, prog test kit, AMH test kit, PGI/PGII test kit, G17 test kit, H.P. IgG test kit, HbAlc test kit, CP test kit, aflatoxin m1 test kit, aflatoxin b1 test kit, OTA test kit, DON test kit, ZEN test kit, cpv test kit, cdv test kit, ccv test kit, ccrp test kit, crn test kit, cprog test kit, fssa test kit, MOP test kit, MET test kit, KET test kit, MOP/MET/KET 3 in 1 test kit, THCA test kit, cocaine test kit, MDMA test kit, fentanyl test kit, etc.

Application of lateral flow test kit

For human being diseases or fertility diagnostics (for example: pregnancy test kit, HIV, HCV, etc.)
For animal diseases diagnostics (for example: FMD, brucellosis, etc.)
For pet diseases diagnostics (for example: CDV, CPV, fSAA, etc.)
For plant diseases diagnostics (for example: rice blast, rice bacterial blight, etc.)
For food safety diagnostics (for example: drug residuals in milk, meat, drinking water,  etc.)
For fish disease diagnostics (for example: gill rot disease, Branchiomycessanguinis, etc.)
For natural environment diagnostics (for example: heavy metal pollution, air contamination, etc.)

What kind of lateral flow test kit more popular?

Colloidal gold lateral flow test kit is more and more popular, because it’s quick test, read result within 15 minutes, visible by eye, friendly to use as well. It can bought online, supermarket or drug store.
Immuno fluorescence lateral flow test kit must need a READER to tell test result, not convenient, usually use in laboratory.

How to setup a manufacturing unit for lateral flow test kit?

Here to show you based on Immune colloidal gold technique, what machines will use.

Content:
1. For startup company
2. For medium company who has R&D team
3. For big company who want a mass production

For Startup company

Before manufacturing, you need to prepare two rooms:
1. Manufacturing room 
2. Warehouse

Requirements for room:
1. Manufacturing room
It’s very important to control temperature and relative humidity, special relative humidity, it will affect test kit’s quality
Relative humidity: must be below 30%! 
Temperature: room temperature 
Decoration: use color coated steel sheet to create a room with glass window, it must be a confined-space, otherwise, it’s difficult to control relative humidity. The floor coated with paint. Clean room ready.

Control machinery:
1. Dehumidifier (better to use industrial rotary dehumidifier)
2. Air-Conditioning

Clean room size requirement
For startup, use a small room enough, such as: 100m2 or 200m2

Warehouse room size requirement
For startup, 50 ~ 400m2, basis manufacturing capacity.

Power supply requirement
If use industrial rotary dehumidifier and Central Air-Conditioning System, need to use 380V power supply.
If use normal dehumidifier and air-conditioning system, meet your local regular power supply.

Manpower requirement
Depend on manufacturing capacity, will have different requirement.
If small quantity production, then
1. Manufacturing room:  3 – 5 workers
2. Warehouse room: 3 – 5 workers

What machinery will use for a startup company?

Three basis machines enough for small quantity manufacturing

What lateral flow assay materials will for a startup company?

What ANTITECK can help for a startup company?

ANTITECK provide lab equipment, lab consumable, manufacturing equipment in life sciences sector.

If you are interested in our How To Setup Lateral Flow Assay Manufacturing Plant? or have any questions, please write an e-mail to info@antiteck.com, we will reply to you as soon as possible.