HIT

Part
01
of eight
Part
01

HIT Testing, In House vs. External Testing

The two most significant contributing factors to heparin-induced thrombocytopenia (HIT) are cardiopulmonary bypass surgery and hemodialysis, two diseases with vastly different treatment options and therefore vastly different treatment settings. Cardiology & Heart Surgery hospitals represent 9.9% of the hospitals in the United States and the rate of hospitals that might carry out HIT testing in the US, leaving the other 90% of U.S. hospitals to out-of-hospital testing and treatment.

RESEARCH STRATEGY

We first looked at data on heparin-induced thrombocytopenia and U.S. hospital testing procedures to find out if this would shed any light on which hospital facilities if any, might be outsourcing their HIT testing. Our search led us to the American Heart Association's HIT in Cardiac Surgery report, and a HIT and in-hospital mortality rate article, as well as an article on the treatment and prevention of HIT from the CHEST Journal. These articles are used since these are the most recent and most relevant information available which discussed HIT testing in detail.

Next, we broadened our search to look at HIT and its testing labs. We chose this strategy to discover if non-hospital laboratories were performing HIT testing, and found two laboratories for testing HIT: LabCorp and ARUP Labs. These are U.S. based, off-site laboratories that test for HIT and explain their laboratory procedures, thus lending credence to the idea that there are hospital facilities that do not do HIT testing.
We also searched for hematology laboratories and the US markets to get an idea of the size of the non-hospital affiliated laboratory business market in the region. We hoped that this might give an idea of the number of hospitals or clinics using these facilities. A GlobeNewswire article reported the worth of the Clinical Laboratory, and a MarketWatch article predicted the market growth. However, neither of the reports went into detail about the number of hospitals or clinics that use the services of clinical laboratories.

In order to get the nearest possible number of U.S. hospitals that perform HIT testing in house, we calculated the number of HIT occurrences in the United States, obtained from using the research done on the prevalence of HIT occurrence rates in one hospital, Froedtert Memorial Luthern Hospital in Milwaukee, WI, and expanded that to all 6,210 hospitals in the United States. After determining the occurrence rate was approximately four per U.S. hospital, we then took the data from the Froedtert medical study, citing the primary causes of HIT as cardiopulmonary bypass surgery and hemodialysis. We used each illness and their treatment methods as a proxy to determine the rate of in-hospital or out-of-hospital treatment for HIT testing.

Our findings helped us to establish, through the occurrence rate and distribution of the major illnesses associated with HIT that, only a small percentage of HIT testing was carried out in hospitals, while the vast majority of HIT testing took place outside of U.S. hospitals. We thus concluded that the number of hospitals which perform HIT testing might be based on the prevalence of HIT. However, we were unable to find exact data on hospital procedures regarding heparin-induced thrombocytopenia, i.e., if the hospitals send out testing or if there is no testing done at all. All the source that we found went into detail about the testing procedures and testing results, but not where the testing was performed.

CALCULATIONS

RATE OF HIT OCCURRENCE PER US HOSPITAL
Using the approximation that 1 in 1,500 hospital admissions are HIT-related, we obtain approximately 24,340 HIT contractions out of the total 36,510,207 US hospital admissions (36,510,207/1500).
Spreading the total number of US hospital admissions (36,510,207) over 6,210 hospitals equals approximately 5,880 admissions per hospital per year (36,510,207/6,210). For the 5,880 admissions per hospital divided by the rate of HIT occurrence equals 3.92 or approximately 4 HIT occurrences for every United States hospital per year (5,880/1500).
PERCENTAGE OF IN-HOSPITAL HIT TESTING
Since Heparin complication rates following cardiopulmonary bypass surgery represented the highest HIT according to the Froedtert Memorial Luthern Hospital study, it is proposed as a proxy for performing HIT testing in-house, on the assumption that cardiopulmonary procedures pose a particular HIT risk that would require monitoring and testing.
Of the 6,210 Hospitals, there are 613 Cardiology & Heart Surgery hospitals throughout the U.S., representing 0.0987 or approximately 9.9% [(613/6,210) x 100%], which conduct in-hospital testing for HIT. Thus, the vast majority of U.S. hospitals (90%), may send their out for the HIT test, i.e., [100% — 9.99% = 90.01%].
Hemodialysis care centers are proposed as a potential non-hospital source of HIT testing due to the Froedtert Memorial Luthern Hospital study which cites hemodialysis procedures as the second most significant contributor of heparin-induced thrombocytopenia.

FINDINGS

NUMBER OF HOSPITALS IN THE UNITED STATES
According to the survey conducted by the American Hospital Association, there are 6,210 Hospitals in the United States and a total of 36,510,207 hospital admissions as of 2017. From the total number of US hospitals, there are 613 Cardiology & Heart Surgery hospitals.
NUMBER OF HOSPITALS TESTING FOR HIT
Patient data from Froedtert Memorial Luthern Hospital, Milwaukee, WI., reviewed heparin-induced thrombocytopenia (HIT) patients between 2009 and 2013 and identified 97,566 HIT patients out of over 150 million discharges, which constitutes approximately 1 in every 1,500 hospital admission. Of those patients, those that did a cardiopulmonary bypass had the highest rate of HIT (7,702 out of 1,230,362 patients). Patients undergoing hemodialysis had the second highest rate of HIT, with 23,012 out of 4, 908, 100 patients.
NON-HOSPITAL TESTING FOR HIT
There are approximately 4 HIT cases for every hospital in the US per year, and most of them are sent out for testing, as 90% of US hospitals do not conduct testing of HIT, and only 9.9% do.
Part
02
of eight
Part
02

HIT Test Volume

Annually, 12 million people in the US are exposed to heparin and out of this, 1% to 5% patients "receive a HIT diagnosis." About 4 million HIT tests are being conducted annually in the US.

Using credible sources such as Blood Journal, PR NewsWire, Global News Wire, Cap Today Online, and others we have gathered a lot of relevant information on HIT tests that are being done each year in the US. However, none of these sources directly provided the total volume of HIT tests done per year in the US. During our research, we were able to find a source that talked about the market size of the PIFA test offered by Akers Biosciences. The test claimed to be a faster and cost-effective alternative for traditional HIT testing. The report provided the 4 million figure for the total volume of HIT tests done per year in the US.

THE TOTAL volume of HIT tests done per year in the US

The HIT test is the "only rapid test to detect a potentially fatal allergy (HIT) to the blood thinner Heparin." About 4 million HIT tests are being conducted annually in the US alone. According to PR NewsWire, 2017, annually, about 12 million people are being exposed to heparin and out of which 1% to 5% of patients receive a HIT diagnosis.

Currently, it has been estimated that 0.2% to 2% of patients "who receive prophylactic or therapeutic doses of heparin during their hospitalization will go on to develop HIT." Out of all patients who are investigated for HIT with laboratory testing, only five to 10% diagnosed with this condition.

OTHER USEFUL FINDINGS — HIT and hit testing

HIT was first diagnosed in 1942 in animals and then later in humans as "a transient, nonimmune complication of heparin therapy." This type of HIT is known as type I HIT caused due to "pharmacologic effect of heparin" which is the "agglutinating effects of heparin on platelets"; however, another type, known as type II HIT was discovered in 1958 by two surgeons. HIT type II is the immune complication caused by heparin which is also known as the more serious condition.

HIT (Heparin-Induced Thrombocytopenia) is a type of immune disorder that occurs due to exposure to heparin causing "arterial and venous thrombosis and moderate to severe thrombocytopenia." The incidence rate of HIT is 0.8-1% in hospitalized patients who have been exposed to heparin which is about 20,000 admissions per year on average.

A lot of critically ill patients are being suspected of having HIT due to the reason they have been exposed to heparin. Among medical-surgical ICU patients, up to 45% have less than 150 × 109 platelet count. HIT occurs in about 1% of those patients who are medical-surgical critically ill and in 3% of patients with "at least one criterion to suspect HIT."

Part
03
of eight
Part
03

HIT Testing Factors

Hospitals are most interested in the probability of patients having HIT, costs associated, the timing of results, and possible complications for patients when it comes to deciding on doing HIT testing or not. Some hospitals do not do HIT testing because they lack the resources and expertise to do as well as the stakes are high for patients and hospital if they require the services of other resources.

RESEARCH STRATEGY

In our pre-research, we found articles relating to HIT Testing from the College of American Pathologists and Medscape. However, Medscape requires registration to access information.
We then looked for information in research sources including NCBI, Case Reports in Hematology, Wiley Online Library and found more details in some of them about factors hospitals are the most interested in or consider most when it comes to deciding on doing HIT testing or not to use it.
To get more detailed information on incidence and risk factors associated with HIT Testing, we met a paywall on UpToDate. However, we found collaborating sources providing the information in our research. We also realized that the content provided especially in journals are written by medical practitioners within the field of pathology in the U.S., who work directly with patients or research about patients in hospitals in the U. S who experience HIT Testing. The information gathered was therefore considered representative of U.S. hospitals.

HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) DISORDER AND THE POSSIBLE COMPLICATIONS

Heparin-Induced Thrombocytopenia (HIT) is a very risky disorder that has a mortality rate of 20%. Patients usually require amputation of limbs (5%) and have other morbidity issues example, deep-vein thrombosis, pulmonary embolism, stroke, or myocardial infarction (50%). The patient count of those who are adversely affected by drugs from heparin therapy, resulting in HIT in the US is 12 million. Serotonin release assay (SRA) is the benchmark for HIT Testing.

FACTORS INVOLVED IN HIT TESTING

COST TO PATIENT
Heparin is affordable but other anticoagulants such as agatroban are expensive; amounts to $1000 per day. Should a patient require the need to switch from heparin to agatroban, hospitals would need to charge patients for the new treatment, which is costly. Therefore, they need to consider patients' expenses before ordering a HIT Test. On the other hand, ordering the HIT Testing for a patient who may or may not be critically ill would give specific results that could bypass other expenses related to overtreatment. Hence, the reason why some hospitals may decide to avoid HIT Testing.
UNNECESSARY ADMINISTRATION OF ALTERNATIVE ANTICOAGULANT
Doctors have to make a tough call if they made a prognosis that a patient has HIT. It involves trying to reverse heparin using other anticoagulants (e.g. argatroban) which may not be as effective and lead to excessive bleeding. While doctors have to make this call without the confirmed test results, there is also the fact that many patients who are suspected of this aren't HIT patients. Only 5%-10% of suspected cases, usually confirm the diagnosis.
At Hofstra University Northwell Health Staten Island Hospital physicians experience fear of misdiagnosis, increasing patient exposure to risks of anticoagulation and higher expenses. ELISA for HIT Testing may be ordered excessively to treat patients which results in higher expenses for patients and healthcare system. Hospitals need to consider the sensitivity and weight on physicians in making the right call or the wrong call. The right call could save a patient's life, reverse any complications that may exist, and reduce cost to patient for treatment. On the other hand, the wrong call could pose complications for patients who are unconfirmed for HIT, resulting in more expenses, more complications to their health including excessive bleeding. For these reasons, hospitals may avoid doing HIT Testing since this could also result in several lawsuits depending on the outcome.
MAKING DECISIONS
Physicians have been using the 4T score to do pre-testing of patients for HIT and to prevent unnecessary halt of treatment using heparin therapy and overtreatment with alternative anticoagulant. After the publication of the Choosing Wisely guidelines, there was a reduction in the repeated testing of HIT to diagnose patients. Choosing Wisely guidelines recommends the use of 4T scores first. The guidelines specify that physicians should not do HIT Testing if 4T scores are low on probability. The 4T scores is the most common pre-testing method for HIT, with probability of it being confirmed based on 0-3: low (<1-4% risk), 4-5: intermediate (8-29% risk) and 6-8: high (21-100% risk).
Since the publication of the Choosing Wisely guidelines hospitals have realized the seriousness of misdiagnosing, overdiagnosing, mistreating or overtreating patients in HIT Testing and have opted for the utilization of 4T scores instead. They have since decided to use 4T scores more rather than repeating HIT Testing. 4T scores is only a pre-test of the probability of having HIT for patients which means hospitals also have to consider the possibility of a later onset of HIT as well. It may also be a turn-off for hospitals to do HIT Testing because it can also present as false negative at first and change to a positive later.
DELAY IN TEST RESULTS
Serotonin release assay (SRA) is the benchmark for HIT Testing but it's unfortunate that the number of expertise and resources are not readily available of accessible which results in late retrieval of results. Undoubtedly, this could also lead to misdiagnosis and mistreatment. Repeat testing of PF4-H AB ELISA and SRA is recommended in patients with high clinical suspicion who initially test negative. Hospitals might consider other tests first like ELISA or 4T scores because of the turnaround time.
PSSIBLE COMPLICATIONS FOR PATIENT LIFE
The issues surrounding HIT Testing results in unwarranted expenses, overdiagnosis as well as overtreatment. Excessive bleeding may occur as a result of misdiagnosis and mistreatment. Although SRA is the gold standard, it is possible that the results in the early stages of the disorder may be a false-negative. While hospitals might have access to the benchmark means of HIT Testing, it is imperative to do re-testing if a false-negative result is received on a patient that is has "strong clinical suspicion". After admission, a patient suffered from several complications presented due to and related to existing medical conditions. However, the patient also had HIT Testing done which was false negative (day 7 in hospital) and so continued the use of heparin infusion which lead to a decrease in platelets. Having a repeat HIT Testing confirmed HIT diagnosis on day 8, which lead to treatment with bivalirudin and warfarin and a successful treatment. A quick turnaround time in HIT Testing is salient. The HIT mortality rate for patients who are critically ill is 30%. There is no hospital that wants to have a bad reputation for a high mortality rate with patients having HIT or over-diagnosed with HIT Testing and so may make the decision to avoid it.
COST TO HOSPITAL
Hospitals save more when they avoid or lessen the use of the alternative anticoagulant, argatroban. Between 2007 and 2011, UT San Antonio experts found that they saved $220,055 annually by lessening the use of argatroban and using the 4Ts scoring system instead(pretest probability test calculator for HIT). During the same period, the pretest probability test calculator for HIT saved them $18,448 in laboratory costs. Like many other centers, UT San Antonio doesn't have the resources for HIT Testing, so they also have to wait. However, if they had the resources for HIT Testing (gold standard SRA), the hospital would be able to save $191,128 in HIT Testing annually. Also, hospitals would need to provide the new anticoagulant, agatroban which is also expensive to the institutions and the turnaround time is too long, so some hospitals might not do HIT Testing and opt for other options first.

Widely Used Alternative to SRA used in the U.S.

On July 26, 2016, there was approval from the Food and Drug Administration for hospitals with ACL TOP Family Hemostasis Testing Systems to conduct HIT Testing which can give results in half an hour. Enzyme-linked immunosorbent assays (ELISA) are mostly used in the US for HIT testing, with 99% sensitivity and only 30 — 70% specificity. ELISA is used instead of SRA (the best option) and takes only two hours to process samples but with insufficient sensitivity. While ELISA has a short process time, the wait time due to limitations of resources could be from a few hours to a few days. ELISA is more affordable than HIT Testing and may be considered by hospitals as first option.

Part
04
of eight
Part
04

SWOT of HIT Testing Industry

There were no publicly available comprehensive SWOT analysis of the Heparin Induced Thrombocytopenia (HIT) testing industry but several related insights were derived from various reports. The strength of the Heparin-Induced Thrombocytopenia (HIT) testing industry revolves around the need for more testing due to the widespread use of Heparin in treatment areas. The weakness of the industry was derived as the industry's lack of strategy to explore the need for more tests to be done. The opportunity of the industry to grow lies in its taking advantage of various testing scenarios needed. Meanwhile, threat to the industry's growth was inferred to be the patients' or physicians' decision not to do testing if there are no evidence of Heparin in the area.

METHODOLOGY

We started our research by looking for directly available studies or reports that contain an analysis of the strength, weaknesses, opportunities, and threats of the Heparin Induced Thrombocytopenia (HIT) testing industry. We searched for this information in medical, scientific, and academic sources such as NCBI, SCIRP, Healthline, WebMD, Mayo Clinic, The Lancet, and other related sites; health-related articles such as those found in Bloodjournal, Health, HelloClue, Very Well Health, and other relevant sites; government sources such as AHA, Department of Health, and other relevant sources. Based on these search approach, we were not able to find directly available reports on the strength, weaknesses, opportunities, and threats of the Heparin Induced Thrombocytopenia (HIT) industry. What we found were several reports that provided some insights, observations, statistics, and findings that involve HIT testing.
We then looked for statements or interviews from healthcare professionals in specialist sites such as Hematology Org, American Society of Hematology, International Society on Thrombosis & Haemostasis, Society for Hematology and Stem Cells (ISEH) to determine if there are specialists that stated any information on the strength, weaknesses, opportunities, and threats surrounding the HIT testing industry. However, we were not able to find comprehensive SWOT-related statements or interviews from these specialists. What we found are just snippets of data on HIT testing in general.
We then checked if clinics, hospitals, or other players in the HIT testing industry such as Quest Diagnostics, Arup Consult, and others commissioned healthcare consultants to produce any HIT testing SWOT analysis. We hoped to find any of these analysis as we looked through the websites of healthcare consulting firms such as Kohler Healthcare Consulting, Navigant, Bain, Simione, Veralon, and other healthcare consulting sites. Based on this strategy, we were not able to obtain any SWOT-related analysis or report findings. What we found are general information on HIT testing.
The reason why the information on the HIT testing industry SWOT analysis is not available could be due to the highly specific and complex nature of this information.
Given the lack of available information on the full SWOT analysis of the HIT testing industry, we then inferred some SWOT-related insights based on the snippets of information we found above using the various search strategies mentioned. Some insights were also considered under all the SWOT categories depending on the perception and impact to the industry. The following section contains our derived SWOT analysis based on the limited information found on the industry.

Heparin-Induced Thrombocytopenia (HIT) Testing Industry SWOT analysis

Strengths

Based on the information that the use of Heparin is prevalent in hospitals and other facilities where patients are treated, the industry can be assured of a strong growth. As more devices, tools, and other hospital provisions need to be treated with Heparin, health facilities will need to do more testing to prevent Heparin complications such as arterial thrombosis.
There are also advanced instruments being developed such as the ACL Acustar Testing .System that can facilitate HIT testing round-the clock. Furthermore, there are no special training needed to use the instrument. With this, it is expected that more patients can be tested using this new instrument.
The HIT testing industry's growth can also be further propelled by the launch of another new test called the HemosIL HIT-Ab(PF4-H) assay. This assay is considered to the first HIT testing process to be completely automated.

Weakness

The HIT testing industry's weakness can be their lack of strategy to actively look for additional scenarios where testing needs to be done. In a report from ISMP, there were several cases of HIT cases that were caused by patients' exposure to unexpected Heparin sources such as devices, tools, and other hospital implements. HIT could have been prevented or addressed if only HIT testing was done in these scenarios.

Opportunities

Given that patients can develop HIT symptoms after being exposed to unknown sources of the Heparin substance, there is an opportunity for the industry to analyze and explore the need for more HIT testing for all hospital or clinical stays. Since there is a prolific use of Heparin around the treatment areas, there is a high probablity of patients developing HIT symptoms from these exposures even if the substance is not directly used in their primary treatments. The HIT testing industry can then benefit from this additional requirement.

Threats

As patients and physician are sometimes not aware of unexpected Heparin sources, some may opt out of testing as they may find this unnecessary. This can then have a negative impact on the growth of the HIT testing industry.
Part
05
of eight
Part
05

HIT Testing, Key Players

Detailed research reveals that some key players within the HIT testing space include Dana-Farber Cancer Institute (known as Harvard Cancer Center) of the Harvard Medical School, Massachusetts General Hospital (MGH), University of Pennsylvania Hospital, Penn Presbyterian Medical Center, GTI Diagnostics, and the Medical College of Wisconsin. The identified HIT testing institutions have offered test services to several patients and are involved in research work or clinical trials to develop better ways of testing and treating HIT patients.

METHODOLOGY

Detailed research to unearth a comprehensive report that reveals up to five key players and their revenue within the HIT testing space in the United States was futile. There is little broad-scoped information made available to the public regarding key players in HIT testing.

We also performed a detailed review of granular pieces of information obtained from press releases, academic journals, medical industry reports and health facility web pages among other resources. This strategy revealed some players within the HIT testing space in the United States as the Dana-Farber Cancer Institute of Harvard Medical School, Massachusetts General Hospital (MGH), University of Pennsylvania Hospital, Penn Presbyterian Medical Center, GTI Diagnostics, and the Medical College of Wisconsin. There was however no information unearthed regarding the revenue made from HIT testing by any of the listed HIT testing institutions.

All attempts to triangulate the revenue obtained by the above-listed HIT testing institutions proved abortive. The institutions have not provided a breakdown of their income or stated any percentage obtained from HIT testing despite detailed research as they are not under any obligation to disclose such information.

Due to the limited availability of information and inconsistency in metrics made available by various reports on the HIT testing efforts of identified institutions, we have defined vital/key players as follows: Involvement in an ongoing high-level HIT testing program such as clinical trials for about five to seven years as in the case of Dana-Farber Cancer Institute and Massachusetts General Hospital. Performing in-house testing and practically researching the possibility and efficiency of using HEP and 4Ts scores for early diagnosis of heparin-induced thrombocytopenia in patients as in the case of the University of Pennsylvania Hospital and Penn Presbyterian Medical Center. Performing high sensitivity test using automated IgG-specific chemiluminescence immunoassay processes in "certain low-probability situations," and making the results quickly available as with the case of GTI Diagnostics. Offering 24-hours all year HIT testing services and comprehensive reports on HIT risks, stages and strains to patients and the public as in the case of the Asante lab Oregon. Finally, practically experimenting how PEA tests can identify patients suffering from HIT earlier in the course of their disease. PEA tests are efficient even at early periods of infection when SRA and PF4 ELISA are still giving negative/weakly positive results as verified by the Medical College of Wisconsin which we have also considered as a key player in HIT testing. Details of the identified HIT testing players are as follows:

1. Dana-Farber Cancer Institute (Harvard Cancer Center) of the Harvard Medical School

ROLE IN THE HIT TESTING SPACE

The Dana-Farber Cancer Institute (Harvard Cancer Center) of the Harvard Medical School has been conducting tests in Heparin-Induced Thrombocytopenia (HIT) patients through clinical trials since December 18, 2018. The HIT testing program covers hospitalized patients suspected of having HIT and may last till December 31, 2025. Patients are diagnosed and confirmed by Heparin-PF4 EIA or some other accepted HIT confirmatory test.

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by the Dana-Farber Cancer Institute is not available to the public.

2. Massachusetts General Hospital (MGH)

ROLE IN THE HIT TESTING SPACE

Massachusetts General Hospital (MGH) has also been conducting tests in Heparin-Induced Thrombocytopenia (HIT) patients through clinical trials since December 18, 2018. The HIT testing program covers hospitalized patients suspected of having HIT and may last till December 31, 2025. Patients are diagnosed and confirmed by Heparin-PF4 EIA or some other accepted HIT confirmatory test.

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by the Massachusetts General Hospital is not available to the public.

3. University of Pennsylvania Hospital

ROLE IN THE HIT TESTING SPACE

The University of Pennsylvania Hospital has an in-house HIT testing laboratory. The institution is involved in testing HIT patients and verifying the possibility and efficiency of using HEP and 4Ts scores for early diagnosis of heparin-induced thrombocytopenia in patients.

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by the University of Pennsylvania Hospital is not available to the public.

4. Penn Presbyterian Medical Center

ROLE IN THE HIT TESTING SPACE

The Penn Presbyterian Medical Center just like the University of Pennsylvania Hospital has an in-house HIT testing laboratory. The institution is involved in testing HIT patients and verifying the possibility and efficiency of using HEP and 4Ts scores for early diagnosis of heparin-induced thrombocytopenia in patients. HIT laboratory testing in the Penn Presbyterian Medical Center is conducted using a "polyspecific HIT antibody enzyme-linked immunosorbent assay" (ELISA; Immucor GTI Diagnostics Inc, Waukesha, WI) as well as an in-house serotonin release assay (SRA).

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by the Penn Presbyterian Medical Center is not available to the public.

5. GTI Diagnostics, Waukesha, WI

ROLE IN THE HIT TESTING SPACE

GTI Diagnostics utilizes high sensitivity and an automated IgG-specific chemiluminescence immunoassay process for the diagnosis of HIT. The center conducts HIT tests on a commercial scale. The highly sensitive and specific HIT tests offered by GTI Diagnostics is valuable even in "certain low-probability situations," especially when the results are quickly made available. The homepage of GTI diagnostics is accessible via this link.

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by GTI Diagnostics is not available to the public.

6. Medical College of Wisconsin

ROLE IN THE HIT TESTING SPACE

The Medical College of Wisconsin has conducted studies using samples obtained from patients to perform PEA, SRA, and IgG-specific PF4 ELISA tests for HIT. Findings from their test results reveal that PEA tests can identify patients suffering from HIT earlier in the course of their disease. This test is efficient even at early periods of infection when SRA and PF4 ELISA are still giving negative/weakly positive results.

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by the Medical College of Wisconsin is not available to the public.

7. ASANTE LAB, OREGON, USA

The Asante lab offers Elisa, Heparin-PF4 IgG, and other HIT test services to the public. The lab also provides comprehensive reports and useful knowledge to the public on the various stages of HIT infections and types (strains). The lab is always open (it operates from Mondays through Sundays) and boasts of a 1-day analytic time. The Asante lab collaborates with Mayo Clinic Laboratories.

THE AMOUNT OF REVENUE GENERATED FROM HIT TESTING

The amount of revenue generated from HIT testing by the Asante lab is not available to the public.

Part
06
of eight
Part
06

National and Regional Blood Centers Part 1

We have provided the names of fifty-nine blood centers and their locations on the attached spreadsheet rows 2-60, column A and C using the provided resource.
  • The blood center called Vitalant is in Arizona, Colorado, California, Idaho, Illinois, Louisiana, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, North Dakota, South Dakota, Tennessee, Texas, Ohio, Pennsylvania, Washington, Wyoming, and Arkansas in the United States.
Part
07
of eight
Part
07

National and Regional Blood Centers Part 2

Columns B and D, rows 2 to 57 of the attached spreadsheet have been completed. The majority of the blood centers’ websites have provided information on whether they are for-profit or non-profit organizations. Their LinkedIn profiles were examined only if the websites did not explicitly provide their status. We have determined that LifeSouth Community Blood Centers, Blood Bank of Alaska, Vitalant, and the remaining 53 blood centers listed on the spreadsheet are all non-profit/not-for-profit organizations.
Part
08
of eight
Part
08

Total Blood Centers in the US

The number of blood centers in the United States is expected to increase from 2,830 centers in 2016 to reach 2,890 centers in 2019 with an approximate CAGR of 0.71%. Below is an outline of the strategies used to find and calculate the number of blood centers in the United States in 2019.

Methodology

We started our research by looking for resources which directly and credibly provided the total number of blood centers in the United States, including national and regional blood centers. In attempting to locate this answer, we conducted exhaustive research through market reports, statistic portals/databases, and trusted media articles. In pursuit of this strategy, we checked research websites like Research Gate, Docs Player, Industry Daily Observer, Business Wire, and Globe News Wire. We also checked consulting websites such as Statista, Deloitte, KPMG, Accenture, and McKinsey, and media websites like Reuters, Forbes and The NYT.
Therefore, there doesn't appear to be much data or professional research publicly available on this specific topic. However, we found a report from Globe News Wire providing some information about global and U.S. blood and blood components market. However, none of the websites provided any information specifically for the number of blood centers in the United States, including national and regional blood centers.
Further research was made to get more data referring to governmental portals/databases such as The U.S. Department of Health and Human Services (HHS) and the U.S. Government's open data (Data.gov) for any reports about the requested information. However, this approach also did not deliver any results. We only found on the HHS website a report titled “The 2011 National Blood Collection and Utilization Survey Report” which provided details about blood collection in blood centers in the United States. However, none of the details provided answers for the requested data.
As an alternative research approach, we tried to find the requested information by checking industry-related websites/blogs and blood collecting organization. We checked the National Blood Foundation, American Red Cross, America’s Blood Centers, Blood Centers of America, and the Hematologist among others. However, these organizations provided the number of their blood centers. Again, none of the websites provided any information specifically for the number of blood centers in the United States, including national and regional blood centers.
Next, we decided to expand the scope of the research to cover market reports, statistic portals/databases, and trusted media articles published earlier to the 24 months time frame with the aim to find any helpful data to calculate the projection of the number of blood centers there are in the United States, including national and regional blood centers. In order to find such information, we researched again for reports, articles, and statistics through market reports, statistic portals/databases, and trusted media articles. On RAND, we found the number of blood centers in the United States in 2016. Also, on the NYT, we found the number of blood centers in the United States in 1991.
Lastly, information about the number of blood centers in the United States, including national and regional blood centers seems to be not publicly available. Despite a lack of data, we tried to triangulate the requested data by performing the following calculations.

CALCULATION

1) CAGR:
  • The number of blood centers in the United States was 2,370 in 1991.
  • The number of blood centers in the United States was 2,830 in 2016. (Page 8 of the PDF).
  • To calculate the projected number of blood centers in the United States in 2019, we relied on this CAGR calculator. The starting value is 2,370 (1991), the ending value is 2,830 (2016), and the number of periods is 25 (years). We calculated the number of years by subtracting 2016 from 1991 (2016-1991=25). Based on these figures, the calculator states that the CAGR would be around 0.71%.
2) The number of blood centers in the United States in 2019:
  • CAGR = 0.71%.
  • The number of blood centers in the United States in 2016 was 2,830.
  • To calculate the projected number of blood centers in the United States, we relied on this reverse CAGR calculator. The starting value is 2,830 (2016), the CAGR is 0.71%, and the number of periods is 3 (years). We calculated the number of years by subtracting 2019 from 2016 (2019-2016=3). Based on these figures, the calculator states that the 2019 market size would be around 2,890.71.
Lastly, the estimated number of blood centers in the United States in 2019 is 2,890 centers.

Sources
Sources

From Part 01
Quotes
  • "For further information, contact the AHA Resource Center at (312) 422-2050 or rc@aha.org. Total Number of All U.S. Hospitals 6,210 Number of U.S. Community 1 Hospitals 5,262 Number of Nongovernment Not-for-Profit Community Hospitals 2,968 Number of Investor-Owned (For-Profit) Community Hospitals 1,322 Number of State and Local Government Community Hospitals 972 Number of Federal Government Hospitals 208 Number of Nonfederal Psychiatric Hospitals 620 Other 2 Hospitals 120 "
  • "Total Staffed Beds in All U.S. Hospitals 931,203 Staffed Beds in Community 1 Hospitals 798,921 Total Admissions in All U.S. Hospitals 36,510,207 Admissions in Community 1 Hospitals 34,305,620"
Quotes
  • "Between 2009 and 2013, 97 566 discharges from the NIS assigned the ICD-9-CM code for heparin-induced thrombocytopenia, and 149 911 247 discharges coded for non-heparin-induced thrombocytopenia, were analysed."
  • "Overall, heparin-induced thrombocytopenia was identified in 97 566 (0·065%; SE 0·0012) of 150 008 813 discharges, corresponding to approximately one in 1500 hospital admissions."
  • "Patients undergoing cardiopulmonary bypass had the highest rates of heparin-induced thrombocytopenia (7702 [0·63%; SE 0·03] of 1 230 362), followed by those undergoing haemodialysis (23 012 [0·47%; 0·01] of 4 908 100)"
  • "those with gingival or periodontal disease, or both (106 [0·12%; 0·03] of 88 621), and those with trauma or injury, or both (541 [0·09%; 0·01] of 602 944); patients with hip (845 [0·04%; 0·004] of 1 943 353) and knee (676 [0·02%; 0·002] of 3 022 602) arthroplasty had the lowest rates of heparin-induced thrombocytopenia"
  • "Overall, in-hospital mortality was 9842 (10·1%; SE 0·2) of 97 508 in discharge summaries coded for heparin-induced thrombocytopenia compared with 3 206 700 (2·1%; 0·01) of 149 811 891 in discharges for non-heparin-induced thrombocytopenia (adjusted odds ratio 4·075 [95% CI 3·846–4·317]; p<0·0001). "
  • "The median length of stay among live discharges was 8·9 days (IQR 4·6–17·1) and total hospital charges were US$83 072 (IQR 37 240–188 419) for heparin-induced thrombocytopenia discharges compared with 2·6 days (1·4–4·8) and $21 360 (11 426–41 917) for non-heparin-induced thrombocytopenia discharges (p<0·0001 for both)."
  • "333 discharges from a local hospital were analysed to assess the diagnostic sensitivity and specificity of the heparin-induced thrombocytopenia ICD-9-CM code; sensitivity was 90·9% (95% CI 57·1–99·5) and specificity was 94·4% (91·1–96·6)."
Quotes
  • ".S. News provides information here about 613 hospitals in Cardiology & Heart Surgery that see many challenging patients, including those needing heart transplants, those with cardiovascular disease and other complex heart conditions. Listed hospitals had to treat at least 1,391 such Medicare inpatients in 2014, 2015 and 2016 in order to be eligible for ranking."
Quotes
  • "The 2018-2019 rankings compared more than 4,500 national medical centers across 25 specialties, conditions and procedures, with 158 hospitals receiving national rankings in at least one specialty and more than 1,100 hospitals considered as high performing in at least one common condition or procedure."
Quotes
  • "If integrated care has a chance of being successful in the End-Stage Renal Disease Program, more than 30,000 patients should be a good sampling. After two rounds of tweaking the rules, the Comprehensive ESRD Care Demonstration has attracted seven dialysis providers and 32,287 patients. Fresenius Medical Care North America and DaVita Kidney Care, ranked #1 and #2 in our 2017 provider survey, respectively, account for 27,000 of those patients. Only U.S. Renal Care, American Renal Associates, and Satellite Healthcare, all providers in the annual survey, are not participating in the five-year demonstration."
From Part 05
Quotes
  • "This research study is studying a drug as a possible treatment for heparin induced thrombocytopenia (HIT) or Heparin-induced Thrombocytopenia and Thrombosis (HITT). The drug involved in this study is apixaban."
  • "Detailed Description: This research study is a Phase II clinical trial. The FDA (the U.S. Food and Drug Administration) has not approved apixaban as a treatment option for this specific disease but it has been approved for other uses. HIT and HITT are common and severe complications of heparin therapy. Once patients are diagnosed with either one of these, they are typically switched to a non-heparin anticoagulant (a type of drug that thins your blood). As of now the only drug that is FDA approved for HIT or HITT is argatroban, which is administered continuously through an IV over multiple days and is extremely costly."
  • "In this research study, the investigators are researching the activity and tolerability of apixaban in participants with HIT or HITT. The investigators believe that apixaban will work just as well as argatroban and will be more convenient for this population. The oral route of apixaban allows for the potential outpatient treatment of HIT or HITT which is both convenient and less expensive than treatment with argatroban."
  • "Official Title: A Phase II Study to Evaluate the Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT) Actual Study Start Date : December 18, 2018 Estimated Primary Completion Date : December 31, 2021 Estimated Study Completion Date : December 31, 2025"
  • "Inclusion Criteria: Hospitalized patients at MGH and participating Dana Farber/Harvard Cancer Center (DF/HCC) sites. Patient must have a diagnosis of HIT or high clinical suspicion of HIT, with a 4 T score of ≥ 5 as calculated by the following criteria: Thrombocytopenia"
  • "Prior to or immediately subsequent to enrollment, the patient must have the diagnosis confirmed by Heparin-PF4 EIA or other accepted confirmatory test to remain on study."
Quotes
  • "Patients Consecutive adult inpatients (≥18 years of age) were recruited from the Hospital of the University of Pennsylvania and an affiliated community hospital, Penn Presbyterian Medical Center, from June 2012 through January 2015. Patients with suspected acute HIT in whom diagnostic HIT laboratory testing was requested were eligible for enrollment. Demographic and clinical information was collected at time of enrollment, during the duration of the patient’s hospital admission, and by telephone follow-up 30 days after enrollment using standardized case report forms."
  • "HIT laboratory testing All patients underwent HIT laboratory testing with a polyspecific HIT antibody enzyme-linked immunosorbent assay (ELISA; Immucor GTI Diagnostics Inc, Waukesha, WI) and an in-house serotonin release assay (SRA) as previously described."
Quotes
  • "Stored sera (n 5 509) and citrated plasma (n 5 429) were available from a prospective evaluation of the 4Ts scoring system.8All patients had a 4Ts score, and results from the serotonin-release assay (SRA)10,11 and a polyspecific EIA that detects anti-PF4/polyvinylsulfonate antibodies of IgG/IgA/IgM classes (LIFECODES PF4 Enhanced assay;Immucor GTI Diagnostics, Waukesha, WI).12 For this new study, all serum/plasma samples were also tested using an IgG-specific CLIA (HemosIL AcuStar HIT-IgG(PF4-H), Instrumentation Laboratory, Bedford, MA)13; per the manufacturer, a result $1.00 U/mL was considered positive. In addition, we tested sera in a commercial IgG-specific EIA (LIFECODES PF4 IgG assay; Immucor GTI Diagnostics)14 using a high-heparin step per the manufacturer’s recommendations (reactivity of anti-PF4/heparin antibodies is inhibited at suprapharmacologic heparin concentrations).9 All testing was performed by laboratory personnel blinded to sample classification"
Quotes
  • "Results/Discussion Serial samples obtained from both patients were used to perform the PEA, SRA, and IgG-specific PF4 ELISA. Studies were approved by the institutional review board of the Medical College of Wisconsin (protocol PRO00023318). In patient 1 (Fig 1A), the PEA became positive at 152 h (6.4 days) after heparin exposure (69% P-selectin expression) when the SRA was negative (0% serotonin release). At this time, there was a significant drop in platelet count to > 50% of baseline (platelet count immediately before UFH treatment) and the PF4 ELISA was weakly positive at OD 0.67, a value generally not predictive of HIT.14"
  • "Findings made in these cases suggest that the PEA can identify patients with HIT early in the course of their disease at a time when the SRA and PF4 ELISA are negative/weakly positive. The significant drop in platelet count seen in both patients when the PEA first became positive suggests that truly pathogenic antibodies were being detected. Platelet counts decreased further in both patients after SRA and PF4 ELISA seroconversion occurred, likely reflecting increased HIT antibody titers. Of note, the same platelet preparation was used for PEA and SRA testing in patient 1, arguing against platelet donor variability as an explanation for different results obtained with the two assays."
From Part 07