Women’s health
binding protein-1 (IGFBP-1) or placental alpha- microglobulin-1 (PAM-1) test of vaginal fluid for diagnosing PROM.12 Several tests for PROM are available for use in the UK including Amnioquick, a simple, rapid and sensitive test for detection of Insulin Growth Factor Binding Protein-1 (IGFBP-1) from vaginal swab samples. Based on monoclonal antibody technology, Amnioquick can detect IGFBP-1 at concentrations of 5 ng/mL test with no interference from other proteins. The test is sensitive enough to detect IGFBP-1 in a few microliters of amniotic fluid. The presence of IGFBP-1 in cervicovaginal secretions is consistent with PROM when the clinical diagnosis is uncertain.
Preterm labour The earlier a baby is born, the greater the chance that they will suffer serious and long- term health problems. A baby’s organs finish developing near the end of pregnancy. If a baby is born early, those organs may not have enough time to grow. While many health problems related to preterm birth can be treated, some children born prematurely may have problems throughout their lives, such as developmental problems or learning disabilities. Foetal fibronectin is a protein that acts as the “glue” a pregnant woman’s body makes to hold her baby in the uterus. When the body is getting ready to give birth, this glue breaks down and leaks into the vagina. If the fFN protein is detectable in vaginal discharge before 35 weeks’ gestation, it means that the protein is “leaking” which could indicate the body is getting ready to deliver early. It’s been over 25 years since the immuno-
chromatographic foetal fibronectin test (fFn) test was developed,13
and its use as a preferred
marker for preterm labour in the UK is outlined in the NICE Guidance on Preterm Labour and Birth (NG25). Until July 2024 Hologic’s Rapid fFN was the first line fFN test of choice across maternity units in the UK. The test resulted in a quantitative result for fFN that that could be entered into the QUiPP app, a decision support tool that uses medical history, a quantitative foetal fibronectin result and/or cervical length to give an individualised score for the risk of having a spontaneous preterm delivery.14 The recent announcement by Hologic, that
they are withdrawing their fFN test from the marketplace from September 2024 has left those involved in perinatal care seeking to find an appropriate alternative test. While it would seem logical that an alternative fFN test should replace it, fFN is not the only biomarker of preterm labour. The speed with which Hologic is exiting the marketplace has added a sense of urgency in the hunt for an alternative. HealthcheX Foetal Fibronectin Test is a
test that can be performed by a vaginal swab to estimate the risk of preterm labour by measuring the fFN in vaginal fluid. The HealthcheX Foetal Fibronectin test is a simple and accurate in vitro test for qualitative detection of fFN. The immunochromatographic test can detect fFN at 50ng/mL and above a high sensitivity and specificity. When sample is applied to the test cassette, it reacts with the antibodies impregnated on the membrane and moves up via lateral flow/capillary action. If fFN is present in the sample, a coloured band appears on the test region indicating positive. The test can be used almost anywhere to detect if preterm delivery is likely to occur in pregnant women between 24- and 34-weeks’ gestation.
In the case of the withdrawal of Hologic’s Rapid fFN test, it could be that this has presented the diagnostic industry and the clinician’s relying on accurate diagnostic information, an opportunity to reexamine different ways, novel ways, and hopefully better ways of assessing whether a woman is at risk of preterm labour. Indeed, one area that seems to be garnering interest is the role that Interleukin (IL)-6, a pro-inflammatory cytokine, plays in preterm birth. Recent evidence has suggested, IL-6 in amniotic fluid and cervicovaginal fluid might be useful for predicting preterm birth.15 Biosynex, have developed a test that brings several preterm labour biomarkers together in a single test. Premaquick is a rapid multiparameter test for the in vitro detection of IGFBP-1 (Insulin-like Growth Factor-Binding Protein 1), fragmented forms of IGFBP-1 and IL-6 (Interleukin 6) in vaginal secretions. The test is intended for assessing the risk of imminent birth between 22 and 37 (+6 days) weeks of amenorrhea in women who present with threatened preterm labour (PTL). To conclude, as we have seen in our earlier examination of the development of POCT diagnostics since Ancient Egyptian times, necessity has been the mother of invention in point-of-care diagnostic testing. If we learn nothing else from history, it is that we cannot put our proverbial diagnostic eggs in one basket. We need to be seeking out new ways of testing, challenging accuracy, developing new antibodies, building tests with combinations of biomarkers, repurposing and advancing technologies but, most of all, keeping an open mind.
CSJ
References 1. The History of the Pregnancy Test from Rabbit Tests to Websites, https://www.early-
pregnancy-tests.com/history
2. Rompalo AM, Castleberry N, Widdice L, Schulkin J, Gaydos CA. Patterns of point- of-care test use among obstetricians and gynaecologists in the US. Sex Health. 2018 Jul;15(4):318-324. doi: 10.1071/SH17180. PMID: 29914611; PMCID: PMC6450764.
3. Meletis J. The beliefs, myths and reality surrounding the word hema (blood), from homer to the present time. Anemia.
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