Lateral Flow Assay POC Manufacturing

Our Lateral Flow Rapid Tests are manufactured in the USA. We can assist from design and inception or can take over from where you feel most comfortable.
Assisting clients with initial beta testing and viability to high-volume commercial production. If you have a Rapid Device and would like to improve the assay or reagent, North American Diagnostics can assist with lamination improvements to poly or monoclonal antibody edits. 

After contract manufacturing for over 20 years in the U.S. nutraceutical arena, we made a natural and organic transition to the poin-of-care lateral flow device manufacturing arena amplifying our core specialties.

Lateral flow tests have different names in different countries and different sectors. Some of the most common names are:

  • Lateral flow device (LFD)
  • Lateral flow test (LFT)
  • Lateral flow immunoassay (LFIA)
  • Lateral flow assay (LFA)
  • Dipstick
  • Lateral flow immunochromatographic assays
  • Express test
  • Quick test
  • Rapid test
  • Pen-side test
  • Test strip

We are very selective with which OEM or ODM clients we work just as you have to be selective with your contract manufacturer.

LAUNCH CAPACITY

For our select clients, we have made a commitment to be able to go from zero to 5 million sku’s within the same 30 days as your initial launch date.

SPIKE CAPACITY

Due to the popularity and  explosion of the Rapid Test POC marketplace here in the USA and overseas, we now have the ability to produce in aggregate 18 million, single-sku items monthly. Within 90 day, cycled increments, it can expand to 18 million units per month, 36 million units per month and 72 million units per months over the 12 month cycle. 

GLOBAL CAPACITY

We have also created an expanded “on-demand & in-place” master contract system with cooperative, contractual, accountable, partner, ISO manufacturing sites to be able to produce a combined, aggregated 250,000,000 mono-Nitrocellulose lateral flow assays on a monthly basis. The lead time is 4 months. For Q1 2022, we will have completed and beta tested our ability to produce the 250 million units per monthly output of  our purpose-built, expanded, tri-continent manufacturing system.

We want to help you worry less so that you can focus more on building your company and rely on us to deliver RELIABLE, ON-TIME, QUALITY, PREDICTABLE, REPRODUCIBLE, PRECISE, CONSISTENT, ODM OR OEM, DURABLE & ACCURATE LATERAL FLOW IMMUNOASSAY TEST KITS

Please Contact Us TODAY!

IVD Medical Device Contract Manufacturer

Lateral Flow Immunoassay Kit

We are reputable united states technical designer & trouble shooter of existing lateral flow test kits to improve efficacy. Also, we don’t insist on long term contracts and our manufacturing quality standards are  ISO-certified. Current Good Manufacturing Practices (CGMP) license with last audit of 10/7/21, compliant with CLSI EP25-A and ISO 23640:2011

Some of our clients require us to drop ship tests or offer fulfillment services even outside of the U.S. We possess adaptability in response to demand spikes or supply chain crimping. We can offer in-house regulatory for both USA and international market penetration.

The quality of the raw materials which go into YOUR lateral flows should be of utmost paramount to your core goals. If you save 15 cents per kit, but receive complaints your first year, your business could suffer not due to your abilities, but due to the complaints and returns or worse. Contract manufacturers who shop for the least expensive raw materials from the cheapest sources,  can ultimately create a recall of your product of which it may take you years to recover. Its just not worth it. Imagine the damage to your reputation and loss of business opportunity.  

North American Diagnostics Leading edge POC LFA Manufacturer. A respected and proven POC lateral flow assay manufacturer in the United States, USA. North American Diagnostics offers lateral flow assay ODM contract-manufacturing services, including OEM (original equipment manufacturing) and ODM (original design manufacturing). With over thirty years of experience contract manufacturing in the highly regulated , Pharmaceutical & Device arena. With God’s grace, we strive to ensure that we deliver the finest quality products, ethically, and efficiently, OEM or ODM. YOUR American partner, conveniently  located in Daytona Beach, Florida, USA. 

We provide services for following products

  • POC Qualitative IVD Medical 
  • Point of care Semi-quantitative IVD 
  • POC Quantitative lateral IVD Lateral

At the end of the day, it’s all about being customer centric, making sure we show our clients that Point-of-care becomes Point-of-trust. 

What Does Lateral Flow Immunoassay Mean?

Probably you have heard of lateral flow immunoassay and been wondering what could it be. This part covers all what it entails. A lateral flow immunoassay is a diagnostic device used in confirming the absence or presence of a target analyte. These analytes could be pathogens or biomarkers in animals or humans or contaminants present in animal feeds, water supplies or foodstuffs. Pregnancy test is the most popular lateral flow rapid test strip.

LFDs contain a control line used to determine if a test is working correctly together with one or more target lines. These LFDs are made to incorporate intuitive user protocols and need little to no training to operate. LFDs could be read visually and qualitative or give data when blended with fascinating reader technologies.

Lateral tests are employed in point-of-care testing for the human health. These tests can be done by healthcare practitioners or by patients in different settings such as the laboratory, home, or at the clinic. Medical diagnostic industry has some strict regulatory requirements that must be followed for all manufactured and developed products. North American Diagnostics provides a superb guideline on how to go about these products. Lateral flow rapid tests can be used in other industry sectors because of their flexible nature. These sectors may include plant and crop health, pharma, food and feed testing, environmental testing, and animal health.

Lateral Flow Immunoassay Kit

LATERAL FLOW TEST TYPES

Lateral flow assays are created to be implemented in a housed cassette or a dipstick format. Both housed tests and dipstick tests work in almost the same manner. However, they are dependent on the sector they appear in, the market requirement, and the sample matrix to determine the most suitable format.

There are two assay types; competitive assay and sandwich assay.

Competitive assay (inhibition immunoassay format)-this assay represents a positive test but there is no colored line at the position of the test line. A line in the test region represents a negative test. Examples of this test format are tests for toxins and drugs. This test format is employed for small molecular weight analytes with single antigenic determinants.

Sandwich assay (non-competitive immunoassay format)-this assay represents a positive test in the form of a colored line at the position of the test line. A negative test is showed by the absence of a line in the test region. Examples of this test format are over-the-counter pregnancy tests. This format works for sizeable molecular weight analytes with multiple antigenic sites.

The non-competitive immunoassay has lower analytical sensitivity compared to the competitive format. Non-competitive formats suffer from a high-dose hook effect when subjected to a high analyte concentration, which leads to false results. Competitive format, on the other hand, does not experience the high-dose hook effect.

SAMPLE MATRICE

To determine the type of sample to use in an assay, the market requirements and target analyte must be considered. Some samples like the animal feed need running buffer to assist in sample delivery, while samples like serum, saliva, urine, or blood can be tested directly. In some occasions, a dilution buffer is more fruitful.

Some tests for the quantitative estimation of lambda immunoglobulin and kappa free light chains (FLCs), utilizes serum and still needs a buffer for the sample solution. 

In other instances rapid antibody tests recognizes IgG antibodies that targets the stubborn SARS-CoV-2 spike protein, utilizing  buffers. 

TYPES OF LABELS 

Lateral flow assays generally make use of conjugated carbon, gold, or colored latex nanoparticles in the combined pad for labeling. Other labels are colored polystyrene beads or magnetic beads.

Labels perform the same function regardless of what label types they are which is creating a three-way bond with targets and antibodies to make the test and control lines visible. Labels are selected depending on factors like sample matrix, antibody, and target. This label selection is done during lateral flow development to ensure assay optimization. The label interacts perfectly with the antigen and antibody to ensure accurate results and efficiency is obtained.

MULTIPLEXED LATERAL FLOW ASSAYS

The competitive and sandwich assays can both be customized to include one or several test lines. Our nucleic acid lateral flow immunoassay, PCRD, for example, is a unique assay with a single control line and two test lines. Competitive and sandwich multiplex assays can be implemented using complementary reader technology to produce quantitative results.

A multiplexed assay is used for the following purposes:

  • Assisting diagnosis where several markers are required to be present.
  • Confirming if multiple contaminants are present during high volume feed and food testing.
  • Testing in remote areas with limited resources where multiplexed testing saves a lot of time.
  • Offering cost-saving advantages to the final users in-the-field or in a laboratory by testing for different targets.
  • Detecting multiple targets in one test instead of using several individual tests. In instances where a small sample volume is what is acquired, a multiplex assay will allow the users to maximize its use in testing.

QUANTITATIVE RAPID LATERAL FLOW DEVICES

Using titles like a quick test or rapid test can lead to misconceptions about lateral flow equipment where it may mean they will be limited in their capability.

Some myths about lateral flow devices are;

  • They can only be qualitative.
  • Their accuracy does not meet laboratory requirements.
  • They are not flexible enough to meet evolving and growing diagnostic challenges.

However, lateral flow devices are very effective, easy to use, compact and they offer a considerable amount of flexibility. Earlier Lateral Flow types were mainly qualitative assays, but improvements in component materials, reagents, and reader technologies together with manufacturing processes imply quantitative results are attainable. Development in reader technology and raw materials like labels indicate that lateral flow rapid tests can counter-part the ELISA assay’s sensitivity.

HOW A LATERAL FLOW TEST WORKS

LFDs apply immunoassay technology by use of colored nanoparticles (or labels), nitrocellulose membrane and antibodies to get results. Upon the addition of a sample, the flow is expected along the lateral flow test device, via the conjugate pad and then directly into the nitrocellulose membrane. The flow ends on to the absorbent pad.

How a sandwich assay works:

 

  • The sample pad is the first stage in the absorption process, which sometimes contains a filter to make sure a controlled and accurate sample flow happens.
  • The conjugate pad containing antibodies and conjugated labels receives the sample. In case the required target is present, the conjugate labels and antibodies fuse with the target and continue migrating along the test.
  • As the sample flows along the gadget, binding reagents found on the nitrocellulose membrane combine with the target where the test line appears. This forms a colored line whose density varies according to the amount of target present in the sample. Some targets require quantification to check the target concentration. To provide quantitative results, the rapid test is infused with a reader.
  • After passing through the nitrocellulose membrane, the excess sample is absorbed into the absorbent pad. The choice of absorbent pad used will have some effect on the volume of the sample to be used.