Laboratory diagnostics

In the mid-20th century, two discoveries heralded the beginning of modern laboratory diagnostics and paved the way for the emergence of two new fields: Rapid point-of-care tests, and highly complex central laboratory analysis. 

1941: Clinitest

Mixing, heating, long waiting periods – until the 1940s, urine analysis in the lab was a long and drawn-out process. That all changed with the arrival of Clinitest, an effervescent tablet combining all the necessary reagents for a rapid urine test for diabetes screening. By mixing the tablet with a few drops of urine, blood sugar levels could be determined after a brief wait based on the color change observed. The invention, by a company called Miles – now merged with the Siemens Healthineers Diagnostics division – laid the foundation for modern point-of-care diagnostics.

 

 

In 1956, a method was devised to apply the reagents to strips of paper – the first Clinistix test strips. The strips only had to be briefly dipped in urine, yielding a result after just ten seconds. Clinistix cemented the arrival of a new method in laboratory medicine known as “dip-and-read” diagnostics. Subsequent versions, such as Multistix in 1984, featured additional test pads for measurement of other parameters. Test strips remain a part of the standard toolkit used by any doctor’s practice or laboratory to this day.

1957: AutoAnalyzer

Frustrated by how long blood tests took to perform in a medical laboratory in the 1950s, biochemist Leonard Tucker Skeggs began tinkering in his cellar at home. The result of his efforts was an “interesting piece of junk”, as he at first jokingly called it. However, the creation had the potential to revolutionize the field of laboratory diagnostics. The company Technicon (subsequently, integrated into Siemens) recognized this potential and hired Skeggs, who spent the next three years refining his idea until the AutoAnalyzer was launched on the market in 1957.

 

 

The device combined mechanical components such as a peristaltic pump with apparatus for dialysis and analysis, connected to each other in a groundbreaking setup: Samples flowed through the AutoAnalyzer continuously, separated by air bubbles. Besides revolutionizing many areas of laboratory work, the system is also responsible for the boom in laboratory automation observed in the 1960s.

1960s: Corning Model 12

Today, blood gas analysis is an essential tool in emergency medicine, providing a quick measure of cardiac, pulmonary, and metabolic function. From just a few drops of arterial blood, small portable systems such as the RAPIDPoint 500® can provide accurate lab-quality test results within 60 seconds. While modern systems are able to measure all blood gas parameters, in the early 1960s there was no way of determining even blood oxygen levels.

 

 

A key milestone in the history of blood gas analysis was the Corning Model 12, featuring an electrode made of highly specialized glass able to measure blood pH without distorting the results for other blood components. Blood gas and pH were still measured separately. A further breakthrough came in 1971, with the Corning Model 165 – the first device able to determine pH, partial oxygen pressure (pO2), and partial carbon dioxide pressure (pCO2) from a single blood sample.

1976: CLINITEK Analyzer

The invention of Clinistix prompted the development of numerous other test strips for urine and blood analysis. These strips could be read with the naked eye by comparing them against color tables – a straightforward and practical process still used today in small medical practices or by private users. However, for larger sample volumes such as those dealt with by hospitals, where hundreds of tests must be evaluated each day, automatic measurement systems can help save a great deal of time while providing reliable results.

 

The first such system, adopted by medical laboratories in 1976, was the automatic urinalysis system CLINITEK Analyzer. Strips were read by placing them in the device, which could measure 37 different urine values in 30 seconds. In this way, up to 60 strips could be evaluated in an hour.

 

Nowadays, compact and highly specialized devices bring the laboratory directly to the patient. Whether in primary and emergency care or at the patient’s bedside, these systems allow critical information to be obtained from the patient’s blood. One example is the Xprecia Stride™, only slightly larger than a smartphone, which can quickly provide reliable, lab-quality coagulation analysis.

2016: Atellica® Solution

Countless researchers and developers at the predecessor companies of the diagnostics division of Siemens Healthineers have made decisive contributions to the evolution of modern laboratory diagnostics. In 2016, Siemens Healthineers took another step into the future with Atellica® Solution.

 

 

Atellica® Solution is a groundbreaking clinical chemistry and immunodiagnostics system. It is particularly remarkable for the advances made in terms of the flexibility and speed of analyses: For instance, the system can be set up in over 300 different configurations of up to ten components in order to make the best use of available lab space. The magnetic sample transport technology is up to ten times faster than conventional laboratory conveyor belts. An Atellica® Solution immunoassay system has the capacity to analyze over 400 samples per hour. Thanks to intelligent scheduling software, each sample is individually registered and dealt with according to its priority level, ensuring that urgent samples take precedence over those for routine exams.