Infectious Diseases

Infectious diseases are conditions that are associated with the transmission of a micro-organism (e.g. a bacterium or virus) from one human host to another. These micro-organisms produce ill health by multiplying themselves and affecting human cells in ways that may kill or ‘poison’ them. New “hosts” may be infected through contact with micro-organism-contaminated food, water or body fluids.

Tropical Diseases

Tropical diseases are infectious diseases associated with micro-organisms that have been found to originate in “exotic” locations such as rainforests or jungles. Tropical diseases are often present in animals, but some can also infect humans. Human infection can often occur as a result of tourism or contact with specimens from the tropical “ground zero”. Once this has occurred, tropical disease infection can result in epidemics due to factors such as air travel and urban life.

Women’s Health

Women’s health involves the prevention and treatment of conditions such as gynaecological cancers and sexually transmitted diseases. These conditions may affect reproductive health, but are also often relevant to other arenas such as a woman’s mental health, health in advancing age and her overall lifespan. The likelihood of such an issue is currently thought to be strongly associated with genetic predisposition; therefore, genetic screening and testing may take an increasingly central role in women’s health.

Oncology – NGS

Next generation sequencing (NGS) is a powerful method of genetic analysis that may assess hundreds of genes in tandem¹. Cancer may involve the actions and interactions of many tumor cell genes. NGS has also demonstrated the ability to model biochemical strategies that target cancers with new and existing therapies².

Transplantation

Human transplants are procedures in which damaged organs are replaced or augmented with suitable tissues from healthy donors. Transplant patients often require continual monitoring for transplant success, health and possible infection. This can be done using laboratory tests for biomarkers, proteins and (if necessary) dangerous bacteria or viruses³.

References

1. Ghosh A, Schlecht H, Heptinstall LE, et al. Diagnosing childhood-onset inborn errors of metabolism by next-generation sequencing. Archives of disease in childhood. 2017.
2. Ikemoto H, Lingasamy P, Anton Willmore AM, et al. Hyaluronan-binding peptide for targeting peritoneal carcinomatosis. Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine. 2017;39(5):1010428317701628.
3. Ansari I-uH, Allen T, Berical A, Stock PG, Barin B, Striker R. Phenotypic analysis of NS5A variant from liver transplant patient with increased cyclosporine susceptibility. Virology. 2013;436(2):268-273.

Immunoassay

An immunoassay is a biochemical laboratory procedure that detects the compound to be tested using antibodies or antigens. These are large proteins that can be specifically designed to attach themselves near-perfectly to the specific molecule that you need to detect¹. The specific antigen or antibody then indicates the presence of its target in a sample (usually liquid) by causing it to change colour or become fluorescent¹. They can also be used to measure how much of a target molecule is present in a sample. Immunoassays are a highly accurate method of detection that can detect a range of substances, including drugs, hormones and disease biomarkers.

Real Time PCR

Real time PCR (RT-PCR) is an ingenious process by which a specific piece (or sequence) of DNA is replicated (or amplified) many times over. The original form of PCR was intended to make the detection of DNA in samples (often present in tiny, sometimes almost negligible amounts) easier. However, PCR, which is based on the natural way in which DNA is ‘manufactured’ in cells (i.e. the polymerase chain reaction) can also be used to analyse how often a sequence is likely to be replicated in such a procedure, and thus how much of it was originally present². This is done by assessing the replication as it happens (i.e. in ‘real time’) during a PCR procedure. RT-PCR can be used in cases for which DNA is often very difficult to detect, including those involving possible viral infections².

DNA Hybridization

DNA hybridization is based on the principle that DNA, which is present in long, molecular ‘strands’ called sequences, is made up of two sub-strands that complement each other perfectly. This is done to maintain the integrity and conformation of the sequence. Therefore, one sub-strand from a particular sequence can be isolated and put into a solution with a second sub-strand from a different sequence. They are encouraged to form a complete sequence (or hybridize), if possible². The presence and degree of hybridization indicates the similarity between two separate DNA sub-strands². Therefore, DNA hybridization can be used to assess questions such as genetic similarity between two separate organisms.

Transcription Mediated Amplification

Transcription Mediated Amplification (TMA) is a laboratory procedure that is compatible with more genetic molecule types (e.g. DNA or RNA) compared to other methods (e.g. RT-PCR)³. Therefore, it may detect RNA and DNA in samples that may contain genes from many sources (e.g. a combination of human and bacteria) with rapid, efficient results³. It is typically used to detect pathogens or foreign bodies in a clinical or pathological setting. TMA can also be used in situations that call for rapid, specific analysis with relatively few steps and equipment requirements, including Zika-virus detection procedures³.

Microbiological Phenotypic Susceptibility

Viruses and bacteria acquire drug resistance by changing the proteins found on their surfaces⁷. This is particularly relevant in epidemics involving drug-resistant bacteria or transplant surgeries⁷. Phenotypic susceptibility analysis evaluates the presence of these proteins by studying virus or bacterium at a molecular level⁷.

Genotypic characteristics refer to the properties of genetic material (e.g. DNA) alone, whereas phenotypic characteristics encompass how genetic attributes translate into the biological and behavioral aspects of the actual organism in question. Phenotypic characteristics include how an organism (e.g. a bacterium) reacts and adapts to agents intended to kill it (i.e. drugs or antimicrobial compounds)⁴. These characteristics are the basis of drug resistance among microbes⁴. Their observation and analysis is termed microbiological phenotypic susceptibility (MPS). MPS analyses and assays are carried out to validate or back up molecular or genetic assays of drug resistance⁴. In addition, they may be used to manage the possibility of false positives in these genotype-based methods⁴.

Next Generation Sequencing

Next-generation sequencing (NGS) is a collective term referring to a range of high-tech assays, applications and automated processes that accurately sequence genes (most often in the form of DNA) at an efficient rate⁵. DNA sequencing is a process in which individual DNA sources are analyzed for their content, properties and functions in the body⁵. NGS has progressed to the point at which hundreds of genes can be analyzed simultaneously and in relation to each other⁵. This gives a picture of how individual genes interact in the body to produce states of health or disease⁵. NGS currently plays an increasingly common role in medical diagnoses and research⁵.

Cardio and Metabolic Biomarkers

Some metabolic disorders (e.g. hyperlipidemia) affect the probability and/or severity of cardiovascular conditions⁸. This is due to biomarkers or biochemical interactions that affect the risk and progression of both disease types⁸. These biomarkers can be found circulating in the blood, the analysis of which is referred to as cardio-metabolic hematology.

Conditions such as obesity and hyperglycemia are associated with certain blood proteins. By studying and measuring these proteins, known as metabolic biomarkers, a person’s risk of developing the relevant conditions can be determined. Alternatively, tracking these biomarkers in the lab can assess a patient’s response to treatment for their metabolic disorder.

Viral Genotyping

Viral genotyping is a process in which the genetic material of individual viruses are sequenced or characterized in-depth using laboratory methods such as RT-PCR⁹. This is done to analyze the virus in question, and its ability to cause disease in animals or humans⁹. Viral genotyping also allows the detection of differences among viruses of the same strain (or family) that may confer new traits (e.g. viral drug resistance)⁹.

Therapeutic Drug Monitoring

When a patient is on a regular drug regimen, the drug molecules are processed (or metabolized) as they circulate in the body. The efficiency of drug metabolism may affect the risk of overdose and/or unwanted side-effects over time¹¹. Laboratory tests such as immunoassays can be used to monitor this risk through drug metabolism analysis, and even help optimize dosing and dose-timing as the patient continues their treatment¹¹.

References

1. Yan X, Zhao Y, Zhang Y, Qu H. Monoclonal Antibodies and Immunoassay for Medical Plant-Derived Natural Products: A Review. Molecules (Basel, Switzerland). 2017;22(3).
2. Schubert S, Wieser A, Bonkat G. [New microbiological techniques]. Der Urologe. Ausg. A. 2017.
3. Chotiwan N, Brewster CD, Magalhaes T, et al. Rapid and specific detection of Asian- and African-lineage Zika viruses. Science translational medicine. 2017;9(388).
4. Louie M, Cockerill FR, 3rd. Susceptibility testing. Phenotypic and genotypic tests for bacteria and mycobacteria. Infectious disease clinics of North America. 2001;15(4):1205-1226.
5. Ghosh A, Schlecht H, Heptinstall LE, et al. Diagnosing childhood-onset inborn errors of metabolism by next-generation sequencing. Archives of disease in childhood. 2017.
6. Ikemoto H, Lingasamy P, Anton Willmore AM, et al. Hyaluronan-binding peptide for targeting peritoneal carcinomatosis. Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine. 2017;39(5):1010428317701628.
7. Ansari I-uH, Allen T, Berical A, Stock PG, Barin B, Striker R. Phenotypic analysis of NS5A variant from liver transplant patient with increased cyclosporine susceptibility. Virology. 2013;436(2):268-273.
8. Phillips CM, Tierney AC, Perez-Martinez P, et al. Obesity and body fat classification in the metabolic syndrome: impact on cardiometabolic risk metabotype. Obesity (Silver Spring, Md.). 2013;21(1):E154-161.
9. Fuentes-Mattei E, Giza DE, Shimizu M, et al. Plasma Viral miRNAs Indicate a High Prevalence of Occult Viral Infections. EBioMedicine.
10. Devaraj S, Cao J, Roper SM. To Fast or Not to Fast?: Comments on the Consensus Statement From the European Atherosclerosis Society/European Federation of Clinical Chemistry and Laboratory Medicine. Archives of Pathology & Laboratory Medicine. 2016;141(4):487-489.
11. Mandrioli R, Protti M, Mercolini L. Novel Atypical Antipsychotics: Metabolism and Therapeutic Drug Monitoring (TDM). Current drug metabolism. 2015;16(2):141-151.

This notice describes how medical information about you may be used and disclosed and how you can receive access to this information. Please review it carefully.

BOCA BIOLISTICS REFERENCE LABORATORY PRIVACY PRACTICES

Boca Biolistics Reference Laboratory (“BBRL”) is committed to protecting the confidentiality of your medical and health information (“protected health information”) as described in this notice and maintains the privacy of your protected health information as required by law. We have provided this notice to you to describe the way we may use and share your protected health information. This notice describes our privacy practices relating to protected health information, including how we may use your protected health information within BBRL and how under certain circumstances we may disclose it to others outside of BBRL. This notice also describes the rights you have concerning your own protected health information. Please review it carefully. If you have questions about any part of this privacy notice, or if you want more information about the privacy practices of BBRL, please contact us directly.

USES AND DISCLOSURES OF PROTECTED HEALTH INFORMATION PERMITTED BY LAW

The law permits us to use your protected health information for treating you and billing for services and healthcare operations, as explained below. Certain types of protected health information have additional protection under state or federal law. For example, information about genetic testing and mental health treatment or conditions may have added protection. To disclose this type of information to others, BBRL is required to get your authorization as described below.

Your protected health information may be used and disclosed only for the following purposes:

For treatment: We may use your protected health information to provide you with medical treatment and other services. We may also disclose your protected health information to others who need information to treat you, such as doctors, physician assistants, nurses, medical and nursing students, technicians, therapists, emergency service and medical transportation providers, medical equipment providers, and others involved in your care. For example, we will allow your physician to have access to your laboratory results to assist in your treatment and for follow-up care.

For payment: We may use and disclose your protected health information to get paid for the medical services and supplies we provide to you. For example, your health plan or health insurance company may ask to see parts of your medical record before they will pay us for your treatment.

For healthcare operations: We may use and disclose your protected health information for healthcare operations, which include patient and internal education, administration, planning, and other various activities that improve the quality of care we provide to patients. We may disclose protected health information to outside companies to support administrative functions, such as data analysis or accounting or legal services, but we will only do so after they have signed an agreement stating that they will abide by our privacy policy.

To business associates: We may provide your PHI to other companies or individuals that need the information to provide services for us. These other entities, known as “business associates,” are required to maintain the privacy and security of PHI. For example, we may provide information to companies that assist us with billing of our services.

To family members and others involved in your care: We may disclose your protected health information, unless prohibited by applicable federal or state law, to a family member, another relative, a close personal friend, a person identified by you who is involved in your medical care, or someone who helps pay for your care. If you do not want us to disclose your protected health information to family members or others, please contact BBRL directly.

For research: We may use or disclose your protected health information without your consent or authorization for research projects, such as studying the effectiveness of a treatment you received, if an institutional review board approves a waiver of authorization for disclosure. These research projects must go through a special process that protects the confidentiality of your protected health information.

As required by law: Federal, state, or local laws sometimes require us to disclose protected health information. For instance, we are required to report child abuse or neglect and must provide certain information to law enforcement officials in domestic violence cases. We also are required to give information to the State Workers’ Compensation Program for work-related injuries.

For public health activities: We may also use and disclose certain protected health information for public health purposes, such as preventing or lessening a serious and/or imminent threat to an individual’s or the public’s health or safety. We may also report information to your employer as required under laws addressing work-related illness and injuries or workplace medical surveillance. For instance, a positive communicable disease test result may be reported to the state health department. We also may need to report patient problems with medications or medical products to the Food and Drug Administration (FDA).

For public health or safety: In limited circumstances, we may disclose protected health information to prevent or lessen a serious and/or imminent threat to an individual’s or the public’s health or safety.

To law enforcement officials: We may disclose protected health information to law enforcement officials as required by law or in compliance with a search warrant, subpoena, or court order. We also may disclose protected health information to assist law enforcement officials in identifying or locating a person, to prosecute a crime of violence, to report deaths that may have resulted from criminal conduct, and to report criminal conduct at BBRL.

For military, veterans, national security, and other government purposes: If you are a member of the armed forces, we may release your protected health information as required by military command authorities or to the Department of Veterans Affairs. We may also disclose protected health information to federal officials for intelligence and national security purposes, or for Presidential Protective Services.

For judicial proceedings: We may disclose your protected health information if we are ordered to do so by a court or if we receive a subpoena or a search warrant.

For health oversight activities: We may disclose protected health information to a government agency that oversees BBRL or its personnel, such as the federal agency that oversees Medicaid and Medicare (CMS), and the Food and Drug Administration (FDA), to ensure compliance with state and federal laws.

To coroners, medical examiners, and funeral directors: We may disclose protected health information concerning deceased patients to coroners, medical examiners, and funeral directors to assist them in carrying out their duties.

For organ and tissue donation: We may disclose protected health information to organizations that facilitate organ, eye, or tissue donation or transplantation.

USES AND DISCLOSURES WITH YOUR AUTHORIZATION

BBRL cannot use your Protected Health Information for anything other than the reasons mentioned above, without your signed “Authorization”. An Authorization is a written document signed by you giving us permission to use or disclose your Protected Health Information for the purposes you specifically set forth in the Authorization. You may revoke the Authorization, at any time, by delivering a written statement to BBRL directly. If you revoke your Authorization, BBRL will no longer use or disclose your Protected Health Information as permitted by your Authorization. However, your revocation of Authorization will not reverse the use or disclosure of your Protected Health Information made while your Authorization was in effect.

YOUR INDIVIDUAL RIGHTS

Right to request your protected health information: You have the right to access your protected health information (laboratory testing). You must make the request for such protected health information in writing or by calling Client Services at 844-561-2275. A notarized authorization form will be required and BBRL will provide that to you. Within thirty (30) days after our receipt of your request you will receive a copy of the laboratory testing unless an exception applies. Exceptions include if the access is reasonably likely to endanger the life or physical safety of you or another person as determined by a licensed health care professional. If the results cannot be produced within the thirty days, you will be notified by mail.

To request the forwarding of your protected health information to your healthcare provider, write to BBRL directly. We may charge a fee for the costs of copying, mailing, or other supplies associated with your request, but we will let you know about the fee in advance.

Right to request amendment of protected health information you believe is erroneous or incomplete: If you examine your protected health information and believe that some of the information is wrong or incomplete, you may ask us to amend your record. We will comply with your request unless we are not the originator of the information or we believe that the information you request to be amended is accurate and complete or special circumstances apply. To ask us to amend your protected health information, write to BBRL directly.

Right to receive an accounting of disclosures of your protected health information: You have the right to request a list of certain disclosures we make of your protected health information. If you would like to receive such a list, write to BBRL directly. Your request must state a time period desired for the accounting, which must be within six years prior to the date of your request. We will provide the first list to you free of charge, but we may charge you for any additional lists you request during the same 12- month period. We will tell you in advance what this list will cost, at which time you may withdraw or modify your request.

Right to request restrictions on how BBRL will use or disclose your protected health information for treatment, payment, or healthcare operations: You have the right to request us not to make uses or disclosures of your protected health information to treat you, to seek payment for care, or to operate our laboratories. We will consider your requests carefully, but we are not required to agree to your requested restriction. If you want to request a restriction, submit your request in writing to BBRL directly and describe your request in detail. BBRL’s privacy officer will reply within 30 days of receiving your request.

Right to request special communications: You have the right to ask us to communicate your protected health information by alternative means of communication or at alternative locations. For example, you can ask us not to call your home but to communicate with you only by mail. To make such a request, write to BBRL directly.

Right to receive a paper copy of this notice: If you have received this notice electronically, you have the right to a paper copy at any time. You may request a paper copy of the notice by contacting BBRL directly, and we will mail the notice to you.

CHANGES TO THIS NOTICE

From time to time, we may change our practices concerning how we use or disclose protected health information or how we will implement patient rights concerning such information. We reserve the right to change this notice and to make the provisions in our new notice effective for all protected health information we maintain. If we change these practices, we will publish a revised notice. You can receive a copy of our current notice at any time by printing a paper copy of the notice or by calling or writing to BBRL.

QUESTIONS, CONCERNS, OR COMPLAINTS

If you have any questions about this notice or have further questions about how BBRL may use and disclose your protected health information, please contact BBRL directly. We welcome your feedback regarding any problems or concerns you have with your privacy rights or how BBRL uses or discloses your protected health information.