Human Biological Specimen Collection Services for Clinical Research in Africa

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.

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.

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.

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.

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

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

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

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

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.

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

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