Sunday November 14th 2021
“Key to Rapid Diagnosis”
Israel introduces first saliva pregnancy test
Traditional home pregnancy tests identify an increase in the level of the hormone beta-hCG in the urine. An Israeli startup now wants to bring a test on the market that detects the hormone in saliva for the first time.
According to its own statements, an Israeli company wants to bring the world’s first saliva pregnancy test onto the market. The product of the startup company Salignostics is to be presented at the medical technology trade fair Medica (November 15 to 18) in Düsseldorf, which starts on Monday. The Salistick basically works in a similar way to a conventional urine pregnancy test.
For the saliva test, however, an absorbent stick must first be put into the mouth and then into a narrow test container. Within minutes, one strip for not pregnant and two strips for pregnant appear on an advertisement. According to the manufacturer, the saliva test can be used from the first day of a missed period. Accordingly, it has a sensitivity of 95 percent and a specificity of 97 percent. The sensitivity indicates how well a test detects a pregnancy. The specificity is how many women who are not pregnant are recognized as such.
The company has applied for CE marking and expects to bring the product to market in Europe within a few months, possibly even by the end of the year, a spokesman said. Manufacturers use the CE mark to ensure compliance with European protection and quality standards. According to Salignostics, the new test can identify the pregnancy hormone beta-hCG in saliva with great accuracy. The company has completed clinical tests on more than 300 women in Israel and several thousand analytical tests. Saliva is “the key to quick diagnoses,” said Vice Managing Director Guy Krief.
Complete upheaval on the market is unlikely
The Salistick can replace blood and urine samples when diagnosing pregnancies. The global market for pregnancy tests is worth more than two billion dollars. At 13 euros, the Salistick should cost about as much as conventional urine tests, the company said. The Israeli company has already issued a corona spit test that is approved in the European Union.
Christian Albring, President of the Professional Association of Gynecologists, told the German Press Agency: “The new pregnancy self-test made from saliva is indeed an innovation in terms of the diagnostic procedure itself, because saliva is no longer used, instead urine is used. According to the manufacturer, however a reliable statement can only be made with the saliva test after the menstrual period has ceased. ” A “complete upheaval in the market” is unlikely to be expected in Germany after the new product has been approved, he said. For many women, the first course leads directly to their gynecologist anyway. In addition, the conventional tests from the morning urine are very simple.
In order to determine a pregnancy as early as possible, the pregnancy hormone in the blood is determined. An increase in this hormone can often be detected in the urine as early as eleven days after fertilization. The gynecological examination results complement the diagnosis.