Performance evaluation of a smartphone-based home test for fecal calprotection.

OBJECTIVES: Fecal calprotectin (FC) serves as a non-invasive marker for the assessment of gut inflammation in patients with inflammatory bowel disease (IBD). Laboratory measurements are usually performed with immunologic methods like enzyme-linked immunosorbent assay. Recently, quantitative home tests based on the lateral flow technology with smartphones as read-out devices have been developed. We compared the quantitative and qualitative performance of the quantitative lateral flow home test Preventis SmarTest® Calprotectin Home and the immunological test used in our laboratory (Eurospital Calprest® Turbo). METHODS: Fourty-five routine samples were analyzed in parallel with both tests according to the manufacturer's instructions. The read-out of the home test was performed with two smartphones (Apple iPhone 14 Pro and Samsung Galaxy XCover 5). The qualitative interpretation (positive, negative, borderline) was conducted using the cut-offs provided by the manufacturers. RESULTS: Statistically significant correlations with the laboratory standard method were observed for both smartphones (Spearman's rho 0.703 and 0.715, all p<0.005). The home test showed systematically higher concentrations compared to the routine assay. We found minimal qualitative agreement between the two tests (Cohen's kappas (κ)=0.323 and 0.300; p=0.003 and 0.005) showing a lower rate of positives with the home test. Both used smartphones showed good quantitative and qualitative agreement. CONCLUSIONS: The tests are quantitatively not interchangeable. However, the home test may be applicable for the serial follow-up management of patients with IBD. The higher rate of samples classified as negative with the home test may lead to an underestimation of affected patients.

Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing.

Background: Over-the-counter (OTC) diagnostic testing is on the rise with many in vitro diagnostic tests being lateral flow assays (LFAs). A growing number of these are adopting reader technologies, which provides an alternative to visual readouts for results interpretation, allowing for improved accessibility of OTC diagnostics. As the reader technology market develops, there are many technologies entering the market, but no clear, single solution has yet been identified. The purpose of this research is to identify and discuss important parameters for the assessment of LFA reader technologies for consideration by manufacturers or researchers. Methods: As part of The National Institute of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) Tech program, reader manufacturers were interviewed to investigate the current state of reader technology development through several parameters identified as important industry standards. Readers were categorized by technology type and parameters including cost, detection method, multiplex capabilities, assay type, maturity, and use case were all assessed. Results: Fifteen reader manufacturers were identified and interviewed, and information on a total of 19 technologies was assessed. Reader technology type was found to be predictive of other attributes, whether the reader is smart technology only, a standalone reader, a reader with smart technology required, or a reader with smart technology optional. Conclusions: Pairing reader technology with OTC diagnostic tests is important for improving existing COVID-19 tests and can be utilized in other diagnostics as the OTC use case grows in popularity. Reader technology type, which is predictive of core reader attributes, should be considered when selecting a reader technology for a specific LFA test within the context of regulatory guidance. As diagnostics increase in complexity, readers provide solutions to accessibility challenges, facilitate public health reporting, and ease the transition to multiplex testing, therefore increasing market availability.

SPOOC (Sensor for Periodic Observation of Choline): An Integrated Lab-on-a-Spoon Platform for At-Home Quantification of Choline in Infant Formula.

Choline is an essential micronutrient for infants' brain development and health. To ensure that infants receive the needed daily dose of choline, the U.S. Food and Drug Administration (FDA) has set requirements for choline levels in commercialized infant formulas. Unfortunately, not all families can access well-regulated formulas, leading to potential inadequacies in choline intake. Economic constraints or difficulties in obtaining formulas, exacerbated by situations like COVID-19, prompt families to stretch formulas. Accurate measurement of choline in infant formulas becomes imperative to guarantee that infants receive the necessary nutritional support. Yet, accessible tools for this purpose are lacking. An innovative integrated sensor for the periodic observation of choline (SPOOC) designed for at-home quantification of choline in infants' formulas and milk powders is reported. This system is composed of a choline potentiometric sensor and ionic-liquid reference electrode developed on laser-induced graphene (LIG) and integrated into a spoon-like device. SPOOC includes a micro-potentiometer that conducts the measurements and transmits results wirelessly to parents' mobile devices. SPOOC demonstrated rapid and accurate assessment of choline levels directly in pre-consuming infant formulas without any sample treatment. This work empowers parents with a user-friendly tool for choline monitoring promoting informed nutritional decision-making in the care of infants.

A quick test to objectify smell and taste dysfunction at home: a proof of concept for the validation of the chemosensory perception test.

Recent studies have shown the efficacy of a home test for the self-evaluation of olfactory and gustatory functions in quarantined coronavirus disease-2019 (COVID-19) patients. However, testing was often limited to COVID-19 participants, and the accuracy of home test kits was rarely compared to standardized testing. This study aims at providing proof of concept for the validation of the new Chemosensory Perception Test (CPT) developed to remotely assess orthonasal olfactory, retronasal olfactory, and gustatory functions in various populations using common North American household items. In the 2 experiments, a total of 121 participants irrespective of having olfactory and/or gustatory complaints from various causes (COVID-19, sinunasal, post-viral, idiopathic) were tested first, with one or many of the following tests: (i) a brief chemosensory questionnaire, (ii) an olfactory test-Sniffin' Sticks Test (SST) or University of Pennsylvania Smell Identification Test (UPSIT), and/or (iii) a gustatory test-Brief Waterless Empirical Taste Test (B-WETT). We then applied the CPT which yielded 3 different subscores, namely orthonasal, retronasal, and gustatory CPT scores. The orthonasal CPT score was significantly correlated with SST (ρ = 0.837, P < 0.001) and UPSIT (ρ = 0.364, P < 0.001) scores, and exhibited an excellent accuracy to identify olfactory dysfunction (OD) as compared to SST (area under the curve [AUC]: 0.923 [95% confidence interval {CI}, 0.822-1.000], P < 0.001). The retronasal CPT score but not the gustatory CPT score allowed to distinguish between participants with or without subjective gustatory complaint (AUC: 0.818 [95% CI, 0.726-0.909], P < 0.001). The CPT has the ability to identify OD and to quantify subjective gustatory complaints.

Relationship between Consumers' Perceptions about Goat Kid Meat and Meat Sensory Appraisal.

The goat meat preferred by consumers in Spain comes from suckling goat kids, slaughtered at a live weight of 8-10 kg. However, consumption of this meat is very uncommon, so it is necessary to show its value. To achieve this, we planned to investigate consumers' perceptions about goat kid meat and to study whether their perceptions are related to their sensory appraisal of the meat, measured by the mean of the consumers' home tests. The experiment was conducted with 30 volunteer families (from two cities with different consumption patterns), who were surveyed regarding their sociodemographic parameters, purchasing and eating habits, and the importance of the meat's attributes. As a result, four clusters were obtained, which were labeled "negative," "idealistic," "positive," and "concerned about fat content". The parameters of the animal production system were valued differently by the clusters. Meat tenderness, taste, and amount of fat were considered very decisive factors by most respondents. When the goat kid meat was valued, tenderness was considered more important than taste among older people ("negative" cluster), whereas there was not so much difference between the appraisal of all parameters for the other three clusters. We conclude that it is necessary to improve the information received by consumers about goat production systems and meat quality parameters. There is certainly potential for creating new markets, especially targeted toward young consumers and considering specific strategies for the different groups of consumers, depending on the region and habits of consumption.

Determining the protocol requirements of in-home cat food digestibility testing.

In-home cat food digestibility testing has the potential to yield data that are highly representative of the pet population for which the food is intended. However, no standardized and validated in-home digestibility test protocols are currently available. Such protocols for in-home testing should address key factors that explain variation in cat food digestibility values and here we investigated the required period of adaptation, fecal collection and sample sizes. Thirty privately-owned indoor housed cats of various breeds (20♀ 10♂, 5.9 ± 3.9 yr, 4.5 ± 1.3 kg) received a relatively low and high digestible complete dry extruded food with the marker titanium (Ti) dioxide. Foods were given in a cross-over design of 2 periods of 8 consecutive days each. Owners collected feces daily for the determination of daily fecal Ti concentrations and digestibility of dry matter, crude protein, crude fat, and gross energy. Data originating from 26 cats were analyzed as mixed models and broken line regressions to investigate the required adaptation and fecal collection period. Bootstrap sampling was used to assess the impact of increasing the number of fecal collection days and sample size on the precision of the digestibility estimates. Feces were collected on 347 out of 416 study days (16 days/cat; 26 cats), implying the necessity for multiple collection days to account for cats not defecating every day. Cats showed stable fecal marker concentrations from day 2 onwards when fed the low digestible food and from 3 onwards when fed the high digestible food. Digestibility values were stable from day 1, 2 or 3 onwards, depending on the test food and nutrient. Increasing the number of fecal collection days from 1 to 6 days did not result in more precise digestibility estimates, whereas increasing the number of animals from 5 to 25 cats did. For future in-home digestibility tests of cat food, the findings support a minimum of 2 adaptation days and 3 fecal collection days. Appropriate sample sizes depend on the test food, the nutrient of interest, and the acceptable margin of error. The findings of this study support the protocol development for future in-home digestibility testing of cat foods.

Determining the protocol requirements of in-home dog food digestibility testing.

In-home pet food testing has the benefit of yielding data which is directly applicable to the pet population. Validated and standardised in-home test protocols need to be available, and here we investigated key protocol requirements for an in-home canine food digestibility protocol. Participants were recruited via an online survey. After meeting specific inclusion criteria, sixty dogs of various breeds and ages received, during 14 consecutive days, a relatively low and high digestible complete dry extruded food containing titanium (Ti) dioxide. Both foods were given for 7 d in a cross-over design. Owners collected faeces daily allowing daily faecal Ti concentrations and digestibility of nitrogen (N), dry matter (DM), crude ash, organic matter (OM), crude fat (Cfat), starch and gross energy (GE) to be determined. Faecal Ti and digestibility values for all nutrients were not different (P > 0·05) from the second day onwards after first consumption for both foods. One day of faecal collection yielded reliable digestibility values with additional collection days not reducing the confidence interval around the mean. Depending on the accepted margin of error, the food and the nutrient of interest, the minimal required sample size was between 9 and 43 dogs. Variation in digestibility values could in part be explained by a dog's neuter status (N, crude ash) and age (crude ash, Cfat) but not sex and body size. Future studies should focus on further identifying and controlling sources of variation to improve the in-home digestibility protocol and reduce the number of dogs required.

Home urinary tract infection testing: patient experience and satisfaction with polymerase chain reaction kit.

INTRODUCTION AND HYPOTHESIS: We sought to evaluate patient satisfaction with a novel multiplex PCR UTI home collection kit for symptomatic UTI in a urogynecologic population. We secondarily sought to characterize reported uropathogens and resistance profiles of uropathogens in this population. We hypothesized that patients would be satisfied. METHODS: This was a cross-sectional study of women who were surveyed later about their experience undergoing evaluation for a UTI with a home UTI test at a large tertiary care urogynecology practice in 2020. Symptomatic patients were sent a home UTI kit. We assessed patient satisfaction at a later time with a 5-point Likert scale and collected baseline information. The primary outcome was patient satisfaction with this experience. Secondary outcomes included type and number of uropathogens on testing. RESULTS: A total of 30 patients [73% white race, mean age 71.9 (SD 12.0) years] were surveyed. Patients responded with a mean score of 4.7/5 to all satisfaction questions. Overall, 86% (26/30) of patients would choose this test again. Of those asked if they would choose this test again outside of the COVID-19 pandemic, 86% responded affirmatively. The most common symptoms reported included dysuria (53%), urgency (37%) and frequency (30%). The most common pathogens identified included Escherichia coli (70%), Enterococcus faecalis (60%) and Aerococcus urinae (43%). CONCLUSIONS: Patients were satisfied with home UTI PCR testing and the majority would choose this option again. Home UTI PCR testing revealed common uropathogens for a population with a high proportion of recurrent UTI, but additional research comparing home versus in-office urine PCR testing is necessary.

Disposable and low-cost pen-like sensor incorporating nucleic-acid amplification based lateral-flow assay for at-home tests of communicable pathogens.

Rapid at-home test is a good alternative to the gold standard quantitative polymerase chain reaction (qPCR) for early identification and management of infected individuals in pandemic. However, the currently available at-home rapid antigen kits and nucleic acid tests (NATs) are prone to false results. Although some CRISPR-mediated NATs enhanced accuracy, long turnaround time (ca. 1 h) and aerosol contamination due to additional open-lid reaction hinder its applicability for self-tests. Moreover, the accuracy of at-home NATs is also impacted by interference of sample matrix due to lack of sample purification. Here we report a Fast, Low-cost, Aerosol contamination-free and Sensitive molecular assay for at-Home tests of communicable pathogens (FLASH) incorporating oLAMP, a recently reported isothermal and target-specific NATs by our group, and a visible lateral-flow readout. The integrated platform enabled sample-to-result SARS-CoV-2 RNA detection in 20-30 min achieving a sensitivity of 0.5 copies/µL in a blinded experiment with a high accuracy comparable with the qPCR. Its prototype consists of two disposable pen-like instruments for single-step sample preparation and contamination-free NATs, respectively. The simplified workflow of the FLASH enabled detection to be readily conducted by untrained users for at-home tests. All in all, the FLASH prototype demonstrates itself to be a promising home-use assay platform for effective mitigation of the pandemic.

Rapid and direct concentration range judgment of lamotrigine in plasma by the multi test lines with different detection limits on the same lateral flow strip.

Continuous and interval monitoring of target drug concentration is of great importance for the effective and controllable therapy of diseases. In this research, the colloidal gold labeled lateral flow strip (LFS) is utilized for rapid and direct judgement of lamotrigine (LTG) concentration range, a specific medicine for epilepsy with the effective therapeutic concentration from 2.5 to 15 µg/mL in serum (corresponding to 25-150 ng/mL after 100-time dilution). Interestingly, two test lines of different detection limits on the same LFS can show different optical signal intensities at the same concentration of LTG in serum. Therefore, for concentration range judgment, it can be directly judged by the combination results of the two test lines on the same LFS without aid of any instruments. Typically, just with the dilution treatment of serum samples for 100 times, three concentration ranges including 0-25 ng/mL, 25-150 ng/mL, and higher than 150 ng/mL can be easily distinguished by the different test line combination results on the same LFS. The clinical serum samples at different concentrations of LTG have also been successfully measured with this multi detection limits LFS, which is 100% consistent with those of the HPLC. The simple operation and judgement standards of LFS with multi detection limits will make the home-test or self-test of therapeutic drug monitoring possible.

Continual and accurate home monitoring of uric acid in urine samples with uricase-packaged nanoflowers assisted portable electrochemical uricometer.

A convenient, fast and non-invasive portable electrochemical uricometer (PUM) assisted with the uricase-packaged nanoflowers (NFs) was constructed for continually and accurately monitoring of uric acid (UA) in urine samples at random intervals in just 20 s. Only a small amount of urine (50 µL) was needed for each test. Electrochemical deposition was adopted to modify gold nanoparticles (AuNPs) on screen-printed carbon electrodes (SPCE) and uricase-inorganic hybrid NFs (UOx-NFs) induced by calcium ions (Ca2+) were introduced for UA detection with expected specificity. Cyclic voltammetry (CV) (detection limit of 8.87 µM and liner range of 0-4 mM) and amperometry (detection limit of 0.82 µM and liner range of 0-5 mM) protocols were studied for UA detection, respectively. Finally, the uric acid in urine had be successfully continually monitored from volunteers with various dietary choosing, the results of which can be adopted as the effective evidence for uric acid control.

Remote testing: Sensory test during Covid-19 pandemic and beyond.

Restrictions adopted by many countries in 2020 due to Covid-19 pandemic had severe consequences on the management of sensory and consumer testing that strengthened the tendency to move data collection out of the laboratory. Remote sensory testing, organized at the assessor's home or workplace and carried out under the live online supervision of the panel leader, represents a trade-off between adequate control and the convenience of conducting testing out of the lab. The Italian Sensory Science Society developed the "Remote sensory testing" research project aimed at testing the effectiveness and validity of the sensory tests conducted remotely through a comparison with evaluations in a classical laboratory setting. Guidelines were developed to assist panel leaders in setting up and controlling the evaluation sessions in remote testing conditions. Different methods were considered: triangle and tetrad tests, Descriptive Analysis and Temporal Dominance of Sensations tests, all of which involved trained panels, and Check-All-That-Apply and hedonic tests with consumers. Remote sensory testing provided similar results to the lab testing in all the cases, with the exception of the tetrad test run at work. Findings suggest that remote sensory testing, if conducted in strict compliance with specifically developed sensory protocols, is a promising alternative to laboratory tests that can be applied with both trained assessors and consumers even beyond the global pandemic.

Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests.

Home testing for infectious disease has come to the forefront during the COVID-19 pandemic. There is now considerable commercial interest in developing complete home tests for a variety of viral and bacterial pathogens. However, the regulatory science around home infectious disease test approval and procedures that test manufacturers and laboratory professionals will need to follow have not yet been formalized by the U.S. Food and Drug Administration (FDA), with the exception of Emergency Use Authorization (EUA) guidance for COVID-19 tests. We describe the state of home-based testing for influenza with a focus on sample-to-result home tests, discuss the various regulatory pathways by which these products can reach populations, and provide recommendations for study designs, patient samples, and other important features necessary to gain market access. These recommendations have potential application for home use tests being developed for other viral respiratory infections, such as COVID-19, as guidance moves from EUA designation into 510(k) requirements.

COVID-19 Testing and Diagnostics: A Review of Commercialized Technologies for Cost, Convenience and Quality of Tests.

Population-scale and rapid testing for SARS-CoV-2 continues to be a priority for several parts of the world. We revisit the in vitro technology platforms for COVID-19 testing and diagnostics-molecular tests and rapid antigen tests, serology or antibody tests, and tests for the management of COVID-19 patients. Within each category of tests, we review the commercialized testing platforms, their analyzing systems, specimen collection protocols, testing methodologies, supply chain logistics, and related attributes. Our discussion is essentially focused on test products that have been granted emergency use authorization by the FDA to detect and diagnose COVID-19 infections. Different strategies for scaled-up and faster screening are covered here, such as pooled testing, screening programs, and surveillance testing. The near-term challenges lie in detecting subtle infectivity profiles, mapping the transmission dynamics of new variants, lowering the cost for testing, training a large healthcare workforce, and providing test kits for the masses. Through this review, we try to understand the feasibility of universal access to COVID-19 testing and diagnostics in the near future while being cognizant of the implicit tradeoffs during the development and distribution cycles of new testing platforms.

Setting up a Virtual Calprotectin Clinic in Inflammatory Bowel Diseases: Literature Review and Nancy Experience.

Technological progress, including virtual clinics, web or smartphone-based applications, and assessment of fecal calprotectin (FC) at home has favored the implementation of treat to target strategies for patients with inflammatory bowel diseases (IBD). Although these innovations are promising and have been associated with a significant reduction in health costs, their application in clinical practice is limited. Here, we summarize the most recent literature on virtual clinics and available FC home tests. In addition, we report the experience of IBD patients monitored through the IBDoc® test at the Nancy University Hospital, focusing on usability testing and patient's satisfaction. This pilot experience shows that a virtual calprotectin clinic doubles adherence rate to FC in IBD patients. This finding is especially clinically relevant in the post-coronavirus disease 2019 (COVID-19) pandemic era, with an increasing use of e-health.

Plant-Derived Extracts Feed-Addition and Packaging Type Influence Consumer Sensory Perception of Pork.

This paper investigates whether the combination of the addition of extracts derived from plants (plants derived extracts, PDE) to pork feedstuff and the meat conservation conditions (packaging and time exposure) affect consumers' perception of pork quality, studied by means of visual appraisal, purchase intention and a home test. The three PDE groups were control, garlic extract and blended oil composed by carvacrol, timol, cynamic aldehide and eugenol extracts. Meat was packed in film, vacuum or modified atmosphere (MAP) packaging. A visual test was designed comprising a four-day storage step followed by a four-day exposure step in a refrigerated island display case. All studied effects influenced visual appraisal scores, being time exposure and packaging effects more noticeable than PDE or pig-sex effects. Meat from MAP scored higher than the rest. Scores decreased as exposure time increased, but this evolution was less perceptible in vacuum packaging and was faster for meat from the garlic group. Only gender affected the visual appraisal scores, with women scoring higher than men. Neither PDE addition nor pig sex affected to purchase intention whereas both exposure time and packaging type did. A maximum of 2 days of exposure would be recommended. In the home-test, meat from male pigs obtained higher scores than meat from female pigs, and none of the consumer-related effects influenced the given scores.

Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples.

BACKGROUND & AIMS: The fecal immunochemical test (FIT) is an alternative to colonoscopy and can increase overall screening for colorectal cancer (CRC). However, little is known about the frequency of and reasons for mishandled FIT samples. METHODS: We performed a prospective study, nested within a randomized controlled trial of patients, recruited from December 2015 through August 2017, who were not up to date with colorectal cancer screening (50-75 years old). The patients were randomly assigned to usual care or outreach groups that received a mailed FIT with low literacy level instructions or a reminder call, or both. We examined frequency of and reasons for mishandled FIT samples, including absence of collection date; time from collection to laboratory receipt of more than 14 days; or mishandling of stool, buffer, or cap. The outcomes were the frequency of mishandled FIT samples, effects of outreach on mishandling, and positive results from the FIT among proper and mishandled samples. RESULTS: FIT samples were returned from 1871 patients assigned to usual care and 3045 who received the low literacy level instructions and a reminder call. In total, 19.8% of samples were mishandled; most of these (93.7%) had not labeled the date of stool collection but were still processed. Of the received samples, 1.2% of were not processed because the time from patient collection to laboratory receipt was more than 14 days. Outreach was associated with a lower proportion of mishandled samples (16.5% vs 25.0% for usual care; P < .0001). The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001). There was no significant difference in proportions of positive results between properly processed samples (7.5%) and improperly processed samples (6.2%) (P = .14). CONCLUSION: In a prospective study of patients who were not up to date with colorectal cancer screening, we found that almost 20% of FIT samples were mishandled, with most patients missing the stool collection date. Patient outreach was associated with a lower proportion of mishandled samples, but there was no difference in proportions of positive results between properly and improperly handled samples. Our findings indicate that routine processing of undated FIT samples is associated with similar rates of positive results. There are limited data on test characteristics for FIT samples beyond the 14 days of stool acquisition. The inclusion of low literacy level instructions with reminder calls was associated with improved patient handling of the FIT sample. ClincialTrials.gov no: NCT02613260.

The HIV self-testing debate: where do we stand?

BACKGROUND: Emphasis on HIV testing as a gateway to prevention, treatment and care has grown tremendously over the past decade. In turn, this emphasis on testing has created a demand for new policies, programs, and technologies that can potentially increase access to and uptake of HIV testing. HIV self-testing (HST) technologies have gained important momentum following the approval of the over-the-counter self-tests in the United States, the UK, and France. While the renewed interest in HST has given rise to a number of high quality reviews of empirical studies conducted on this topic, we have yet to find an article that captures the extent of the debate on HST. MAPPING THE DEBATE: A critical review of the literature on HST was conducted and organized into three categories based on the focus of the article: 1) Empirical research, 2) Arguments, and 3) Context. We focused exclusively on the second category which included ethical analyses, policy analyses, editorials, opinion pieces, commentaries, letters to the editor and so forth. 10 lines of argument on HST were identified in the literature: 1) Individual - Public Health, 2) Strengths - Limits, 3) Benefits - Harms, 4) Screening - Testing, 5) Target - Market, 6) Health Care - Industry, 7) Regulation - Restriction, 8) Resource-Rich Settings - Resource-Limited Settings, 9) Ethical - Unethical, and 10) Exceptionalism - Normalization. Each line of argument is presented and discussed in the paper. CONCLUSION: We conclude by providing examples of critical questions that should be raised in order to take the debate to another level and generate new ways of thinking about HST.

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection.

OBJECTIVES: HIV testing is an important step towards diminishing incident infections. Rapid self-tests whose use is becoming more common in France could help increase access to testing, yet could fail to diagnose HIV during acute HIV infection (AHI). The aim of the present study was to evaluate HIV-detection sensitivity of a commonly used rapid self-test (STAT-VIEW HIV1/2), compared with another point-of-care rapid test (INSTI), among patients presenting with AHI. METHODS: Individuals tested at Saint-Antoine Hospital (Paris, France) with negative or indeterminate western blot (WB) results and detectable HIV-RNA were included. Rapid tests were performed retrospectively on stored serum. Patients with and without reactive rapid tests were compared, while probability of having a reactive test was modelled across infection duration using logistic regression. RESULTS: Of the 40 patients with AHI, 23 (57.5%) had a reactive STAT-VIEW rapid test. Patients with non-reactive versus reactive tests had a significantly shorter median time since infection (p=0.01), time since onset of symptoms (p=0.009), higher proportion with Fiebig stage III versus IV (p=0.003), negative WB results (p=0.007), higher HIV-RNA levels (p=0.001) and lower CD4+ and CD8+ cell count (p=0.03, p<0.001, respectively). When examining sensitivity over the course of AHI duration, the probability of HIV detection was 75.5% at 5 weeks from HIV transmission. The INSTI provided similar results with respect to proportion of reactive tests (62.5%), determinants for non-reactive test and probability of HIV detection at 5 weeks of infection (85.0%). CONCLUSIONS: Over half of AHI patients had reactive serology using the STAT-VIEW rapid self-test when performed on serum samples. Considering that detection sensitivity increased substantially over infection time, individuals should not rely on a negative result to accurately exclude HIV infection within at least 5 weeks of potential HIV exposure. Notwithstanding strong recommendations against rapid test use during AHI, some utility in detecting HIV is observed 5-12 weeks after transmission.