Clinical Diagnostics Report

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 Clinical Diagnostics

South San Francisco, CA (TOSOH) August 24,2009 – Tosoh Bioscience was busy at last month’s annual AACC meeting in Chicago as the company introduced it’s latest advancement in high throughput immunoassay testing – the AIA-2000 Automated Immunoassay Analyzer. The advanced system features a wealth of cutting-edge features as it builds upon Tosoh’s industry-wide reputation as a respected developer of reliable diagnostic systems for Immunoassay and HPLC Testing.

Tosoh Bioscience also sponsored educational seminars at the AACC meeting by renowned Clinical Chemist David Plaut. The seminars covered a wide array of pertinent topics in the field of Clinical Diagnostics including quality control, result accuracy, HbA1c, Cardiac Markers, PTH and Tumor Markers.

AACC Educational Seminars by David Plaut at Tosoh Booth

Introduced with a high level of anticipation, the AIA-2000 was very well received by hospitals and laboratories looking for a high throughput Immunoassay analyzer. The AIA-2000 provides many operational improvements which can result in overall laboratory productivity.   Continue reading »

June 7, 2009 …  At AACC 2009 Annual Meeting in Chicago, IL, Tosoh Bioscience (Booth #3140) will feature advancements in immunoassay and HPLC testing. Events from Tosoh Bioscience include free educational seminars by David Plaut on the booth stage. Plaut’s annual AACC educational seminars are eagerly anticipated as a source of pertinent information from immunoassay and HPLC testing. Also, David provides immunoassay and HPLC case studies for reference. David Plaut will give free CDs of his seminar information to attendees.

AACC 2009 PRODUCT SHOWCASESThere will also be excitement revolving around the Tosoh product line at AACC 2009, as Tosoh will be introducing a new analyzer for immunoassay testing: the AIA-2000 Automated Immunoassay Analyzer. With a throughput of 200 tests per hour, the AIA-2000 provides all the speed and flexibility necessary to excel in high throughput laboratory testing environments. Expanded functionality has been added to the system, improving laboratory workflow and increasing walk away time.

Also for Immunoassay testing, the AIA-360 is a sophisticated system that fits in any lab environment. With a footprint of 16 X 16 X 21 inches and weighing approximately 60 lbs., the AIA-360’s compact design makes it ideal for physician office laboratories, work stations for small hospitals, STAT testing, such as cardiac panels, as well as a dedicated system for specialty testing. With a throughput of 36 tests per hour, the AIA-360 generates its first result in approximately 20 minutes. The cost effective system utilizes the same 10 minute ST reagents as Tosoh’s larger systems, making it the perfect back-up analyzer.

Tosoh’s AIA-600 II is a proven system and has earned the industry-wide reputation of high reliability for immunoassay testing. The analyzer provides big system features in a bench top analyzer. Fitting in just 30 inches of counter space, the AIA-600 II has a throughput of 60 results per hour including STAT assay results in ~18 minutes, making it an ideal solution for time-critical tests such as cardiac markers.

All Tosoh AIA immunoassay testing systems utilize the same Unit Dose Test Cup reagent format, ensuring consistent performance every time. With interchangeable reagents on all Tosoh 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.

For HbA1c testing, Tosoh’s G8 HPLC Analyzer provides one of the industry’s lowest CVs of less than 2%. The NGSP certified instrument-reagent system utilizes the gold standard ion-exchange method for HbA1c testing to effectively monitor glycohemoglobin in diabetic patients. With a compact footprint of 21″w x 19″h x 20″d, the G8 fits easily in most laboratory environments. The G8 provides fast results with an HbA1c analysis time of only 1.6 minutes. Simple touch-screen operation, as well as automatic start-up and daily maintenance make the system extremely user-friendly.

The Tosoh G7 HPLC Analyzer can be used for both HbA1c and beta-thalassemia testing in one compact analyzer.  The system provides beta-thalassemia results in less than 8 minutes with quantification of HbF and HbA2.  Also, the NGSP certified G7 HPLC Analyzer delivers presumptive identification of HbS, C and D; as well as true separation of Labile and Stable A1c.

With the TRCRapid-160 (Research Use Only), Tosoh has responded to the growing need and acceptance of molecular diagnostic devices.  This accurate and full-featured platform delivers accelerated real-time RNA amplification and detection by combining two innovative technologies - the isothermal TRC reaction and the unique INAF fluorescence probe. This technology features much lower reaction times than seen with traditional real-time PCR.  This instrument has the potential to be used in many testing areas, such as infectious diseases, cancer markers and environmental testing.

In 2009, Tosoh Bioscience, Inc. is celebrating 20 years in the diagnostic industry. Started in 1989 as Tosoh Medics, Inc., the company is committed to providing quality diagnostic systems and priority service to laboratory customers. TBI has sustained double digit growth over the past 8 years, surpassing the industry growth of ~ 4%, with 2008 being the most successful year to date. Sales of Tosoh Bioscience analyzers and assays have grown consistently throughout the years.

Tosoh Bioscience
AACC Booth #3140