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Pregnancy Test Kit Manufacturing Process Explained

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Pregnancy test kits often pass through several phases during production. These phases include the creation of the plastic case, assembly of the test strip and absorbent pad, the addition of reagents, and packing. Usually produced separately, the test kit reagents are combined with the test strip during assembly.

The experience of becoming a parent is the most joyous experience a person can have. However, the way to it is unpredictable and full of anxiety. Naturally, one would want a private pregnancy test rather than a public one in a doctor’s lab. 

Taking a pregnancy test at home can reduce anxiety and bring happiness at the start of this long journey. When seeking ways to perform home pregnancy tests, there are several pregnancy test kits accessible at a pharmacy these days. 

Knowing how these test kits are made, if they are safe for use, or whether the results are accurate can significantly help an expecting parent. Many manufacturers pledge to use the highest quality materials and ensure quality checks to bring the most reliable pregnancy test kits to the market. 

Did you know?

Most at-home pregnancy test kits are 98% to 99% accurate when used as instructed. 

What is a Pregnancy Test?

A pregnancy test helps determine whether a woman is pregnant or not. If a pregnancy test shows a positive result, the pregnancy is confirmed. Biological pregnancy tests detect human chorionic gonadotropin (hCG), a hormone the body produces during pregnancy.

The biological test for pregnancy is classified into two types: 

1. Urine Test 

A urine test can be carried out at home and is an excellent way of detecting pregnancy. This test is accessible without a prescription from your physician and comes off the shelf in varied cost ranges. 

In these test kits, the presence of hCG in the urine is looked for. While the tests claim to be accurate, it is essential to consult with your doctor. Use this test kit when you first suspect you are pregnant. 

At-home pregnancy urine tests have certain advantages. 

  • They are affordable and available.
  • Immediate results.
  • Easy-to-use directions. 

Your doctor can also perform a urine pregnancy test to validate earlier results. Urine pregnancy test kits are called “Pregnancy diagnostic test kits.”

2. Blood Tests 

A healthcare practitioner performs the blood test in his or her clinic and involves collecting blood samples. Blood samples are collected and sent to a pathology laboratory for evaluation, and here blood samples are tested for hCG levels. 

A blood test is not very commonly used as it is expensive and produces results that are comparable to a urine test. A blood test is usually reserved for pregnancy-related issues, such as if you’re undergoing fertility medications.

Design of Pregnancy Test Kits

The pregnancy test kit detects pregnancy reliably and precisely. Human chorionic gonadotrophin (hCG), the pregnancy hormone, is detected in urine or serum. 

This test offers early pregnancy confirmation and can be administered at home. 

Certain medications, such as fertility treatments, tranquillisers, anticonvulsants, or hypnotics, can impact the outcome. Gather information about the urine pregnancy test kit before testing at home.

1. Pregnancy Test Kit

The kit is designed to produce findings in just a few minutes. These kits are exceptionally sensitive to HCG, with a detection threshold of 25mlU/ml and near-accuracy results. 

2. Ovulation Test Kit 

The ovulation test kit predicts ovulation in time for the fertility period. Planning around this reproductive window can help you become pregnant. 

The test detects the ovulation hormone lutein (LH) and normally indicates four viable days per cycle. 

The test identifies a rise in luteinising hormone, which occurs a day or two before ovulation. It produces results in around ten minutes and has a near-accuracy rate. 

Most common medicines will have no impact, although those containing HCG or LH may. 

Who Can Take a Pregnancy Test?

Pregnancy tests are taken for a variety of reasons. 

  • When you are trying to conceive
  • If you have issues with birth control methods 
  • If you plan to have a medical procedure or begin using a drug that can be affected by an untimely pregnancy. 

Whatever the cause, the most effective thing to do if you have questions regarding your test results is to contact your healthcare practitioner.

How Does a Pregnancy Test Work?

The pregnancy test process can be explained in the following figure.

 

HCG is the first thing to appear in the urine samples of pregnant women. It’s a hormone that forms roughly ten days after conception when the fertilised egg embeds in the womb. Detection of these hormones in the pregnancy test process confirms pregnancy. 

Many people ask which component females can use as a sample for a pregnancy test, and the answer is urine. Urine is the sample required to test for pregnancy at home, and hCG levels are detected in the urine sample.

Types of Pregnancy Test Kits

The primary distinction between test kits on the market is how the user collects and evaluates a urine sample. 

1. Cassette Pregnancy Kits

Pregnancy Test Kits in cassette form have a circular specimen well for adding a urine sample. They also have a separate window to show the results. 

These are economical for customers’ at-home test evaluation, and the test requires a tiny urine sample. Results are reliable and quick.

2. Midstream Pregnancy Test Kits 

In a midstream variant, the Pregnancy Test Kit includes a handle, a test control window for reading, an absorbing section for the specimen, and a detachable cap to preserve the absorbent tip. Personal test performance requirements include speed, reliability, and practicality. Pregnancy test kits require urine specimens.

3. Strip Pregnancy Test Kits 

A pregnancy test kit in the form of a strip includes a test control strip, a test band to show the result with an absorbent, and a stop band to indicate the contact limit with the specimen. This is generally performed in the laboratory and is the preferred clinical specification for in-lab test performance. 

This test requires urine and serum/plasma specimens; test results are quick and reliable.

Also Read: How is Hair Colour Manufactured? Ingredients and Formula Used in a Hair Dye

The Components of a Pregnancy Test Kit

We generally come across the question of the contents of pregnancy detection kits. Well, a common home pregnancy test includes the following contents:

1. A Strip 

The non-woven fibres form an immunoassay material, which is compressed into a thin strip and coated with reactive antigens. In a series of pregnancy testing stages, the antibodies mix with the pregnancy hormone, resulting in a colour shift, giving the test results.

2. Absorbent Pad

The absorbent material stretches from the test capsule and comes into contact with the urine sample. This is utilised in a specific type of test, and the pad absorbs the fluid and directs it to the immunoassay strip for test results. A widely used pregnancy kit, Prega News, uses these pads like absorbent paper.

3. Plastic Cover or Casing 

The test strip and absorbent pad are protected from environmental pollutants by a two-piece casing that enables the unit to be maintained. Transparent plastic glass on the side of the casing prevents urine from accidentally spilling onto the specimen test strip. It also allows the inspection of test and management zone parts.

4. Reagents and Urine Collecting Pints or Vials

A plastic sample collection cup is provided with test kits that need urine collection as an additional step. They also contain plastic vials containing pre-measured volumes of chemical substances that must be mixed with urine before applying to the test strip.

Manufacturing Process of Pregnancy Test Kit

Manufacturing pregnancy test kits is not very complicated and follows the following steps.

1. Creating the Non-Woven Fibre Strip/Pad 

The suppliers of pharmaceutical accessories manufacture the immunoassay strips used in home pregnancy tests. Non-woven fibres are compressed into a small strip and coated with sensitive antigens. 

These strips are made of fibres such as nylon or microfibre mixes and can be moulded mechanically or thermally into pads. 

This non-woven fabric pad is comparable to those used in disposable diapers and other applications requiring extremely absorbent material. The non-woven pad may be covered with latex before treatment with liquid testing chemicals. 

Up to four antigens can be coated in three distinct zones on the strip. After drying, the pads can be sliced into strips corresponding to the test kit’s size.

2. Making of the Casing 

Injective moulding creates the test kit housing case. Plastics, colourants, and resin modifiers are combined, heated, and injected under pressure into a mould in this process. 

The mould is opened after cooling, and two plastic housing parts are separated. 

One side is moulded with pins that slot into similar holes on the opposite half to hold the parts together. The housing is contoured to keep the immunoassay strip and absorbent pad in place. 

Clear plastic windows are made in a separate moulding procedure. This clear window keeps urine from accidentally spilling on the test strip while allowing the user to see the test and control portions. 

A plastic cap that covers the absorbent pad is manufactured in a separate moulding procedure.

3. Assembly 

The components made in the previous steps are then moved to an assembly process, where the immunoassay strips and absorbent pad are first put into the housing. The clear plastic glass is attached to the upper part using adhesive, and the two halves click together. 

Finally, the cap is screwed on to keep the whole kit intact.

4. Packing 

The completed test kit comes in a foil/plastic composite container with a tiny packet of silica gel preservatives. A desiccant silica traps extra moisture in the container, extending the test kit’s shelf life. 

The container is then carefully sealed shut to reduce air exposure. A cardboard package contains a collated bag and an instruction leaflet. 

Depending on the price and manufacturer, one or two full test kits are provided in each box.

5. Delivery 

The box is now moved down the assembly line. A printer records information such as the product’s manufacture date, expiration date, and lot number. 

The package is moved along the production line and shrink-wrapped for further protection. The final box is then placed in a shipping case for distribution.

6. Quality Control

Manufacturers pay utmost attention to quality assurance regarding pregnancy test kits. All pregnancy test kits go through a quality control check; the checks are performed in-house to check the efficiency and accuracy of the kits. 

Random test kits can be triggered throughout production to see if they perform correctly.

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Conclusion 

Home pregnancy test kits have several benefits. These kits are cheap and readily available, simple to use, and home testing results are instantly available. 

According to the makers, most at-home pregnancy tests are near accurate when used exactly as directed. 

We have described how to use a pregnancy test kit so that you may test for your pregnancy at home without trouble. 

However, following confirmation, you should consult your gynaecologist for further evaluation and a course of action. 

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