Immunoassay Testing

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In-vitro fertilization (IVF) and intra-uterine insemination (IUI) are the most common methods used by fertility clinics. The overall goal of IVF treatment is to increase the number of follicles, prevent premature ovulation (reduce LH) and create the conditions for successful implantation of a fertilized egg.

After the clinic has evaluated the couple for several male and female fertility factors, in addition to the woman’s age, they determine the most appropriate treatment option for the couple. One of the determining factors for egg quality is the Day-3 FSH value. A high FSH predicts poor egg quality. This determines the treatment protocol (GnRH agonist or antagonist protocol).

Once a particular treatment protocol has been determined there are 5 different stages of the IVF procedure.

1. Ovarian stimulation: The goal in this stage is to obtain at least 8-10 mature eggs. The stimulation cycle consists of 8 days starting from Day 2 of the menstrual cycle. Blood work and ultrasound are done 3-4 times during this period. The blood work usually consists of E2 and FSH. There is a direct correlation between the E2 value and the number of eggs/follicles. The physician uses the E2 and ultrasound result to determine if the treatment is going well. If a patient is hyper-stimulated and develops too many eggs, the cycle is usually cancelled. It is therefore very important that the physician be able to review the E2 result and ultrasound on the same visit. Tosoh’s ST AIA-PACK E2 offers results in 18 to 20 minutes. If the blood is drawn as soon as the patient checks-in, the E2 result will be available to the clinician during the ultrasound.

2. hCG trigger: An hCG injection is given on the 9th or 10th day to induce ovulation and final egg maturation. This depends on the size of a mature follicle. A follicle is considered mature if the diameter is approximately 18-20 mm. The E2 level at this stage is around 1000-4000 pg/mL. On the day of the HCG trigger, the E2/follicle ratio should be approximately 100-200 and the progesterone level should be 0.8 ng/mL. Since E2 levels are very high, it is desirable to have an assay that offers a broad assay range. Tosoh’s ST AIA-PACK E2 offers an assay range of 25 to 3000 pg/mL.

3. Egg retrieval: The egg retrieval is planned for 34-35 hours after hCG injection and shortly before that time, ovulation may begin. At this stage the patient should produce enough progesterone for a successful implantation. Progesterone supplements are usually given to prepare the uterus for the implantation.

4. Embryo transfer: After retrieval, the egg is fertilized with the partner’s sperm. The embryo can be transferred on day 3 of fertilization or day 5 (blastocyst) of fertilization. The embryo is carefully placed into the patient’s uterus. Usually 2-3 embryos are transferred and vary from patient to patient.

5. Beta hCG test: If the implantation is successful, the beta hCG test will be positive on the 14th day after egg retrieval. A positive beta hCG indicates pregnancy. The beta hCG doubles very 48 hours and is monitored throughout the pregnancy. The patient usually begins routine pre-natal care by her obstetrician at 12 weeks of pregnancy.

IUI:
In an IUI procedure the patient goes through stages 1 and 2. The stimulation protocol is usually mild to get 1-2 mature follicles. Thirty-four to thirty-five hours after the hCG trigger, the patient is inseminated with the partner’s sperm. The fertilization occurs naturally.

Egg Donation:
If an egg donor is used, the donor goes through stages 1 to 3. Once the egg is retrieved, it is fertilized with the partner’s sperm. The recipient goes through all the stages but the embryo transferred utilizes the egg from the donor.

The IVF process is very involved and has an emotional impact on both the patient and the care givers. Because it is very time sensitive, an assay with fast turnaround time is always desirable. Operators using immunoassay analyzers have to multitask, as both embryologist and andrologist in many clinics. A simple, easy to operate instrument is a good choice. The most important criterion for immunoassays in IVF clinics is the reliability of the assays. An E2 assay with low CVs is important as the day-to-day change in result is monitored throughout the stimulation cycle.

Tosoh offers a very good solution with its menu of reproductive assays. The assay time is 18-20 minutes, which allows the physician time to review the results with the patient on the same visit. Tosoh minimizes heterophile antibody interference by using special Ab coating methods and HAMA blockers in the assays. CVs on the E2 are <8.9%. 90 day calibration stability allows the laboratory to test throughout the cycle, with no re-calibration. All of these features of Tosoh’s reproductive assays ensure consistent, reliable results.

Tosoh Bioscience, Inc. has announced that calibration curve stability for most Tosoh AIA assays has been extended to 90 days. Improved calibration curve stability is made possible through Tosoh’s AIA-Pack Unit Dose Test Cup reagent technology.

Tosoh’s AIA-PACK test cups are single, unitized cups that utilize a dry reagent format which requires no pre-mixing, no pre-measuring, no on-board refrigeration and no waste. The test cup format is used on all Tosoh AIA automated immunoassay analyzers, including the AIA-2000 (200 tests per hour), AIA-1800 (180 tests per hour), AIA-600 II (60 tests per hour), and AIA-360 (36 tests per hour).

Calibration is an extremely important step in immunoassay testing as the value reported is a quantitative estimate of concentration by direct comparison with a calibrator material. The aim of calibration is to improve the accuracy. Reducing the frequency of calibration helps laboratories to reduce overall costs and technician time.
Tosoh’s extensive immunoassay test menu provides a wide range of immunoassay tests including thyroid, cardiac markers, tumor markers, reproductive hormones, anemia markers, metabolic markers and more. All Tosoh AIA-PACK assays now carry 90 day calibration curve stability with the exception of Troponin I, B12 and Folate, which will continue to have the 30 day calibration stability.

AIA-PACK test cups and trays are labeled with code and lot number for automated scheduling and inventory management. A 10 minute incubation protocol provides fast turnaround time. Additionally Tosoh AIA reagents have a shelf life of 1 year from the date of manufacture.
Because AIA-PACK test cup reagents are interchangeable on all Tosoh AIA systems, inventory management is easy and problem free. Transition from one system to another is seamless, ensuring consistent results and efficient, economical operation for the laboratory.

Tosoh Bioscience, Inc. (TBI) provides highly sophisticated diagnostic systems for immunoassay and HPLC testing to doctor’s offices, hospitals and reference laboratories throughout the Americas. Based in South San Francisco, CA, TBI is a U.S. subsidiary of Tosoh Corporation’s Bioscience Division, headquartered in Tokyo, Japan.

Tosoh Bioscience has introduced its latest advancement in high throughput immunoassay testing with the AIA-2000 Automated Immunoassay Analyzer. The anticipated new system builds upon Tosoh’s industry-earned reputation as a trusted developer of accurate and reliable analyzers for immunoassay testing.

Tosoh has added new functionality to the AIA-2000 to increase workflow and minimize time. The user can load up to 960 tests (48 trays) in a new, easy to load hybrid sorter; increasing walk-away time to approximately 4 hours. Tip capacity has been increased to 576, and can be added or changed at any time at the user’s request. Sample racks can be loaded with any combination of 200 bar coded primary tubes or sample cups.

Immunoassay Testing on AIA 2000

The AIA-2000 features fully automated daily maintenance and record keeping, automatic inventory management and automated pre-treatment for assays that require this step. In addition, the analyzer features a 17-inch touch screen panel and improved user interface, allowing easy access to most of the controls from the screen. Multiple robotic arms, new staging platforms and mechanical adjustments speed the overall sample processing. As with all AIA systems, Tosoh’s reagent test cup technology produces accurate and consistent results, requiring no on-board refrigeration, no pre-mixing, and no pre-measuring.

AIA-2000 system features include: throughput of 200 tests/hour, 576 tips (6 tip racks), 2 substrate bottles, walk away time of 4 hours, 3 incubators with different processing steps, 2 sampling arms for faster processing of second reagent, and a full test menu.
The Tosoh booth at AACC 2009 (#3140) will feature the AIA-2000 in addition to an established line of state-of-the-art analyzers for immunoassay and HPLC testing. Tosoh will sponsor educational seminars by David Plaut on the booth stage and a Tosoh AACC 2009 Giveaway which includes a Tosoh tote bag or 1 Gig USB Flash Drive with Product Demonstration. The Tosoh AACC 2009 Giveaway is limited to one gift per AACC attendee, while supplies last.

Tosoh Bioscience

Immunoassay Testing Updates & Advancements from Tosoh Bioscience

(April 28, 2009) … Immunoassay Testing Demonstration Video on Tosoh AIA 360 Automated Immunoassay Analyzer. AIA 360 delivers first result in approximately 20 minutes with a compact size of 16”w x 16”d x 21”h / 61 lbs, making it ideal for physician office labs, small hospitals, cardiac and specialty testing, and as a reliable back-up to larger Tosoh analyzers.  The AIA 360 utilizes Tosoh’s patented Unit Dose Test Cup reagent technology – the same for all Tosoh AIA Systems.

Tosoh AIA 360

Immunoassay Testing Updates & Advancements from Tosoh Bioscience

(April 28, 2009) … Tosoh AIA 600 II Automated Immunoassay Analyzer delivers throughput of 60 Results per hour, STAT assay results in approximately 18 minutes, third generation sensitivity, primary tube sampling, automated sample dilution & pre-treatment and dual clot detection in a compact benchtop system.

Tosoh AIA 600 II

Immunoassay Testing Updates & Advancements from Tosoh Bioscience

(April 28, 2009) … Immunoassay Testing Video on Tosoh AIA 1800 Automated Immunoassay Analyzer. Instrument provides high throughput for high volume laboratories and powerful features.
Tosoh AIA 1800 Automated Immuonassay Analyzer