Human Biological Specimen Collection for Clinical Research

Does your clinical research require human biological specimen collection? We provide specimen collection services for all types of clinical research.

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Specimen Collection Services for Clinical Research - Infiuss Health

Our Specimen Collection Procedure

We manage the collection of urine, serum, and other human biological specimens to support your clinical research. Each type of specimen is collected, transported, and stored according to CDC collection guidelines and international research standards.

Our large collection network allows us to offer the most comprehensive specimen collection services. We also offer patient recruitment services and data collection and curation.

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1. Patient Preparation

Patient preparation is a crucial step in the sample collection process. We provide patient instructions, including date and time of collection, medication restrictions, fasting guidelines, dietary requirements, and other guidelines appropriate to the specimen type and to the clinical goals.

In addition to providing collection instructions, we also collect the patient’s information, such as patient name, date of birth, address, medical history, billing information (if applicable), and more. A high level of transparency is maintained, from obtaining informed consent for the potential future use of samples, to making research results available.

2. Specimen Collection and Handling

Clinical results are only as good as the biological specimen collected. We use clean, dry specimen containers of the proper type for sample collection and transport, including for COVID-19 testing, surgical pathology, muscle biopsies, or any other clinical purpose.

Whether for stool collection, urine collection, blood collection, or any other specimen types, we check that each sterile specimen container is properly labeled and has the correct patient information.

3. Specimen Transportation and Storage

Immediately after collection, blood specimens and other biological samples must be properly stored and transported to the laboratory immediately to ensure quality clinical outcomes.

Each specimen type requires a specific transport medium and storage mode. We use appropriate precautions and follow international storage guidelines for all types of human specimens, including serological tests, respiratory specimens, urine samples, renal biopsies, and more.

4. Specimen Submission

After collecting, processing, storing, and transporting biological specimens, it’s time to submit them to a participating laboratory for analysis.

Each collection container must be properly labeled and identified to ensure accurate test results. Infiuss partners with health centers and clinical laboratories to ensure the timely analysis and processing of biological research specimens.

Specimen Collection with Infiuss

Test Request Form Services

Lab testing of biological specimens is a critical component of a successful clinical research.

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Upon transporting biological specimens to the laboratory, appropriate test request forms must be in place for each specimen submitted to ensure proper handoff between collection personnel and laboratory personnel. We can help you develop and implement appropriate laboratory test request forms or test requisition forms for laboratory testing of specimens.

Types of Specimen Collection

These are some of the common types of biological specimens collected for clinical research. Each specimen is collected into the appropriate sterile container, processed, stored, and transported according to international standards for that specimen type.

Swab specimens, or upper respiratory samples

Fixed tissue, including formalin-fixed paraffin-embedded (FFPE)

Blood draws

Cerebrospinal fluid

Urine and stool samples

Fresh frozen tissue

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A Full Range of Clinical Research Services

Beyond specimen collection, Infiuss is your partner for all clinical research needs. From patient recruitment to clinical data management, pharmacovigilance to site management, we will partner with you for all types of clinical research.

What is a clinical specimen?


A clinical specimen is a biological sample of tissue, serum or plasma, or other bodily fluids. Researchers draw blood, collect urine, swab the upper respiratory tract, or utilize a variety of other collection methods, depending on the type of specimen being collected.

Specimens obtained for clinical research must be placed into a sterile, leakproof container that is properly labeled. Transport tubes and other containers must be properly stored and transported according to standard guidelines for each sample type.

What are 3 ways to collect a urine specimen?


The most common urine collection method is the clean catch method, which involves collecting a midstream urine sample into a dry container. Other methods include urethral catheterization and suprapubic aspiration. Typically, researchers want a morning specimen of urine, meaning a urine sample collected in the morning before a participant has eaten.

What is the best form of viral transport for a viral specimen?


A viral specimen needs to be kept in the proper transport media, which is typically a liquid that is specially formulated to ensure virus stability. In some cases, a viral specimen will need to be frozen on dry ice, or refrigerated. In other cases, freezing and refrigeration are not required.

How do you prepare a patient for a sample collection?


There are different preparation protocols for different specimen types. In general, a research participant must be informed, must give consent, must know where and when the sample collection will occur, and must understand any requirements surrounding food intake and other biological parameters prior to the sample being collected.

What is flow cytometry?


Flow cytometry is the suspension of a biological sample in a fluid, which is then injected into a flow cytometer.

What are the three types of blood specimens?


Blood specimens are typically collected into specialized blood collection tubes via one of the following collection methods:

  1. Venipuncture sampling
  2. Arterial sampling
  3. Fingerstick sampling

What is the major cause of specimen rejection?


The six most common causes of specimen rejection are as follows:

  1. Contamination of the specimen
  2. The specimen was collected into the wrong container or tube
  3. The quantity of the specimen was insufficient for analysis (QNS)
  4. The specimen container was labeled incorrectly
  5. A blood specimen was hemolyzed (the blood cells had begun breaking down)
  6. A blood specimen was clotted

What are the five rejection criteria to reject a specimen?


Clinical researches reject a specimen for any of the following five reasons:

  1. The specimen was incorrectly stored or transported
  2. The specimen had insufficient quantity—QNS (quantity not sufficient)
  3. The specimen was placed into the incorrect media
  4. The specimen was placed into the incorrect collection container
  5. The specimen was incorrectly labeled

What makes a blood sample unusable?


There are three common errors that make a blood sample unusable.

  1. The blood sample has clotted. This can occur if the collected blood is not thoroughly mixed after collection. A blood collection tube must be inverted at least 5 times to mix well.
  2. The blood sample is hemolyzed. Hemolyzation occurs when some red blood cells rupture, releasing hemoglobin to other cells. This spoils the sample.
  3. The blood sample is too small. This is known as “quantity not sufficient” or QNS, and is a common cause of sample rejection.

Can you help with collection of rabies specimens?


Yes, we can help with collection of rabies specimens for clinical research on the rabies virus as well as with all other types of biological specimens.

How do you help avoid issues with specimen identification?


Specimen identification issues arise from sloppy or improper labeling and following of collection protocol. We ensure proper collection and labeling protocol are followed.

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