Use of Oral Fluid in a Rapid Syphilis Test Assay

Abstract Background From 2014 to 2015, the syphilis rate in the United States increased by 19%, reaching its highest rate since 1994. Currently, point-of-care syphilis assays use fingerstick or venipuncture whole blood to identify Treponema pallidum (TP) antibodies by qualitative immunoassay. However, patients and providers prefer oral fluid testing to whole blood testing. In this study, we aimed to determine whether a rapid syphilis test intended for use on whole blood could be used to detect TP antibodies in oral fluid. Methods Oral fluid was collected from 72 participants using the Super•SAL™ Oral Fluid Collection Device (Oasis Diagnostics®, Vancouver, WA). The device uses an absorbent cylindrical pad to collect and filter ~1 mlml of oral fluid. Oral fluid filtrate was tested using the SD Bioline Syphilis 3.0 rapid test (Alere Diagnostics, MA) following manufacturer directions for whole blood. TP particle agglutination (TPPA) and rapid plasma reagin (RPR) results derived from participants’ medical records were used as reference values. We used three different definitions as comparators: 1: TPPA reactive; 2: TPPA and RPR reactive and 3: TPPA reactive and RPR titer >1:4. Those with non-reactive TPPA and RPR results were considered seronegative. We calculated the sensitivity and specificity for definition 1 and sensitivity for definitions 2 and 3. We used the exact binomial method to determine 95% confidence intervals (CI). Results With definitions 1, 2, and 3, respectively, sensitivity was 83.3% (CI: 67.2, 93.6), 86.4% (CI: 65.1, 97.1), and 100% (CI: 71.5, 100). Specificity was 47.2% (CI: 36.5, 75.5). Conclusion The high sensitivity of the SD Bioline Syphilis 3.0 test using oral fluid suggests a strong potential for the development of accurate rapid oral syphilis tests. Sensitivity increased with higher RPR titer. False positive results may be due to the presence of non-venereal treponemal antibodies in oral fluid. Further research and development are needed to optimize specificity. Disclosures All authors: No reported disclosures.

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The performance of hepatitis C virus ( HCV ) antibody point‐of‐care tests on oral fluid or whole blood and dried blood spot testing for HCV serology and viral load among individuals at higher risk for HCV in South Africa

Health Science Reports ◽

10.1002/hsr2.229 ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

Nishi Prabdial‐Sing ◽

Lucinda Gaelejwe ◽

Lillian Makhathini ◽

Jayendrie Thaver ◽

Morubula Jack Manamela ◽

...

Keyword(s):

South Africa ◽

Hepatitis C Virus ◽

Viral Load ◽

Hepatitis C ◽

Whole Blood ◽

Oral Fluid ◽

Point Of Care ◽

Hcv Antibody ◽

Point Of Care Tests ◽

Blood Spot

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Development of a point-of-care assay system for high-sensitivity C-reactive protein in whole blood

Clinica Chimica Acta ◽

10.1016/s0009-8981(03)00113-x ◽

2003 ◽

Vol 332 (1-2) ◽

pp. 51-59 ◽

Cited By ~ 67

Author(s):

Jae Soon Ahn ◽

Sunga Choi ◽

Sang Ho Jang ◽

Hyuk Jae Chang ◽

Jae Hoon Kim ◽

...

Keyword(s):

Whole Blood ◽

Point Of Care ◽

High Sensitivity ◽

Assay System ◽

C Reactive Protein ◽

Reactive Protein ◽

Point Of Care Assay

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Diagnostic tests for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens

Journal of Clinical Microbiology ◽

10.1128/jcm.00211-21 ◽

2021 ◽

Author(s):

Paul C. Adamson ◽

Jeffrey D. Klausner

Keyword(s):

Chlamydia Trachomatis ◽

Neisseria Gonorrhoeae ◽

Bacterial Infections ◽

Point Of Care ◽

High Sensitivity ◽

Population Level ◽

The United States ◽

Nucleic Acid Amplification ◽

Point Of Care Test ◽

Control And Prevention

Chlamydia trachomatis and Neisseria gonorrhoeae are two of the most often reported bacterial infections in the United States. The rectum and oropharynx are important anatomic sites of infection and can contribute to ongoing transmission. Nucleic acid amplification tests (NAATs) are the mainstays for the detection of C. trachomatis and N. gonorrhoeae infections owing to their high sensitivity and specificity. Several NAATs have been evaluated for testing in rectal and pharyngeal infections. A few assays recently received clearance by the Food and Drug Administration, including one point-of-care test. Those assays can be used for testing in symptomatic individuals, as well as for asymptomatic screening in certain patient populations. Routine screening for C. trachomatis in pharyngeal specimens is not recommended by the Centers for Disease Control and Prevention, though is often performed due to the use of multiplex assays. While expanding the types of settings for screening and using self-collected rectal and pharyngeal specimens can help to increase access and uptake of testing, additional research is needed to determine the potential benefits and costs associated with increased screening for rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections on a population level.

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Monitoring DOACs with a Novel Dielectric Microsensor: A Clinical Study

Thrombosis and Haemostasis ◽

10.1055/s-0040-1715589 ◽

2020 ◽

Cited By ~ 1

Author(s):

Debnath Maji ◽

Aman Opneja ◽

Michael A. Suster ◽

Kara L. Bane ◽

Brigid M. Wilson ◽

...

Keyword(s):

Whole Blood ◽

Point Of Care ◽

Oral Anticoagulants ◽

Characteristic Curve ◽

Direct Oral Anticoagulants ◽

Unmet Need ◽

Area Under The Curve ◽

High Sensitivity ◽

Diagnostic Study ◽

Coagulation Tests

Abstract Background There are acute settings where assessing the anticoagulant effect of direct oral anticoagulants (DOACs) can be useful. Due to variability among routine coagulation tests, there is an unmet need for an assay that detects DOAC effects within minutes in the laboratory or at the point of care. Methods We developed a novel dielectric microsensor, termed ClotChip, and previously showed that the time to reach peak permittivity (T peak) is a sensitive parameter of coagulation function. We conducted a prospective, single-center, pilot study to determine its clinical utility at detecting DOAC anticoagulant effects in whole blood. Results We accrued 154 individuals: 50 healthy volunteers, 49 rivaroxaban patients, 47 apixaban, and 8 dabigatran patients. Blood samples underwent ClotChip measurements and plasma coagulation tests. Control mean T peak was 428 seconds (95% confidence interval [CI]: 401–455 seconds). For rivaroxaban, mean T peak was 592 seconds (95% CI: 550–634 seconds). A receiver operating characteristic curve showed that the area under the curve (AUC) predicting rivaroxaban using T peak was 0.83 (95% CI: 0.75–0.91, p < 0.01). For apixaban, mean T peak was 594 seconds (95% CI: 548–639 seconds); AUC was 0.82 (95% CI: 0.73–0.91, p < 0.01). For dabigatran, mean T peak was 894 seconds (95% CI: 701–1,086 seconds); AUC was 1 (p < 0.01). Specificity for all DOACs was 88%; sensitivity ranged from 72 to 100%. Conclusion This diagnostic study using samples from “real-world” DOAC patients supports that ClotChip exhibits high sensitivity at detecting DOAC anticoagulant effects in a disposable portable platform, using a miniscule amount of whole blood (<10 µL).

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Ultrarapid, Ultrasensitive One-Step Kinetic Immunoassay for C-Reactive Protein (CRP) in Whole Blood Samples: Measurement of the Entire CRP Concentration Range with a Single Sample Dilution

Clinical Chemistry ◽

10.1093/clinchem/48.2.269 ◽

2002 ◽

Vol 48 (2) ◽

pp. 269-277 ◽

Cited By ~ 12

Author(s):

Piia Tarkkinen ◽

Tom Palenius ◽

Timo Lövgren

Keyword(s):

Whole Blood ◽

Solid Phase ◽

Point Of Care ◽

High Sensitivity ◽

Clinical Samples ◽

Cardiac Complications ◽

Fluorescence Signal ◽

C Reactive Protein ◽

Reactive Protein ◽

One Step

Abstract Background: Recently, measurement of very low concentrations of C-reactive protein (CRP) has gained popularity as a potential new means for predicting the risk of future cardiac complications. In this study, we demonstrate the feasibility of a kinetic, one-step microparticle assay for quantitative determination of extremely low and high CRP concentrations in the limited timeframe typical for point-of-care testing. Methods: A noncompetitive, kinetic CRP immunoassay was developed that uses individual, porous microparticles as the solid phase. The microparticles were covalently coated with a monoclonal capture antibody, and the monoclonal detection antibody was labeled with europium. The one-step binding reaction was stopped by washing after 2 min of incubation, and the fluorescence signal of individual particles was measured. Results: The analytical detection limit (mean of zero calibrator + 3 SD) was 0.00016 mg/L CRP. Clinical samples were diluted 400-fold before assay to cover the CRP concentration range of 0.064–1200 mg/L. The assay correlated well with the Dade Behring N High Sensitivity CRP assay (for 0–10 mg/L, r = 0.969, Sy|x = 0.68, n = 54; for 0–350 mg/L, r = 0.969, Sy|x = 11.7, n = 100). The within- and between-run CVs based on calculated concentrations were, respectively, 9–16% and 14% at 0.11 mg/L, 4.5–12% and 8.2% at 4.2 mg/L, and 3.5–6.3% and 4.4% at 105 mg/L, with a CV <15% at 0.2 mg/L and above. Conclusions: Use of the kinetic microparticle approach combined with time-resolved fluorometry allows ultrasensitive quantification of CRP in whole blood in 2 min with a linear assay range spanning more than four orders of magnitude.

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A comparison between the Intercept Oral Fluid Collection Device® and urinalysis among Baltimore City probationers

Journal of Criminal Justice ◽

10.1016/j.jcrimjus.2006.05.007 ◽

2006 ◽

Vol 34 (4) ◽

pp. 413-424 ◽

Cited By ~ 7

Author(s):

George S. Yacoubian ◽

Edward J. Cone

Keyword(s):

Oral Fluid ◽

Fluid Collection ◽

Baltimore City ◽

Collection Device

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696 RESULTS OF A MULTI-CENTER EVALUATION OF A NEW RAPID TEST FOR DETECTION OF HCV INFECTION USING WHOLE BLOOD, SERUM, PLASMA AND ORAL FLUID

Journal of Hepatology ◽

10.1016/s0168-8278(10)60698-8 ◽

2010 ◽

Vol 52 ◽

pp. S271 ◽

Cited By ~ 1

Author(s):

S.R. Lee ◽

K. Kardos ◽

G. Yearwood ◽

L. Kurtz ◽

M. Roehler ◽

...

Keyword(s):

Blood Serum ◽

Whole Blood ◽

Oral Fluid ◽

Rapid Test ◽

Hcv Infection

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Rapid detection of SARS-CoV-2 antibodies in oral fluids

10.1101/2020.10.12.20210609 ◽

2020 ◽

Author(s):

Melanie A. MacMullan ◽

Prithvi Chellamuthu ◽

Aubree Mades ◽

Sudipta Das ◽

Fred Turner ◽

...

Keyword(s):

Whole Blood ◽

Rapid Detection ◽

Oral Fluid ◽

Antibody Detection ◽

Enzyme Linked Immunosorbent Assay ◽

Blood Collection ◽

Protective Equipment ◽

Oral Fluids ◽

Collection Device ◽

Detection Approach

AbstractCurrent commercially available methods for reliably detecting antibodies against SARS-CoV-2 remain expensive and inaccessible due to the need for whole blood collection by highly trained phlebotomists using personal protective equipment (PPE). We evaluated an antibody detection approach utilizing the OraSure® Technologies’ Oral Antibody Collection Device (OACD) and their proprietary SARS-CoV-2 total antibody detection enzyme-linked immunosorbent assay (ELISA). We found that the OraSure® test for total antibody detection in oral fluid had comparable sensitivity and specificity to serum-based ELISAs while presenting a more affordable and accessible system with the potential for self-collection.

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