scholarly journals Evaluation of Leukocyte and Bacterial Interference in Point-of-Care Human Chorionic Gonadotropin Tests

2013 ◽  
Vol 33 (6) ◽  
pp. 455-456 ◽  
Author(s):  
John V. Mitsios ◽  
Ann M. Gronowski ◽  
Carey-Ann D. Burnham
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Point Of Care ◽  
Bacterial Interference

scholarly journals Analytical and Clinical Evaluation of the NOWDiagnostics ADEXUSDx Human Chorionic Gonadotropin Test Using Whole Blood

2016 ◽  
Vol 1 (1) ◽  
pp. 67-76 ◽  
Author(s):  
Robert D Nerenz ◽  
Jennifer R Bell ◽  
Nancy Montes de Oca ◽  
Joann Short ◽  
Theresa Mims ◽  
...  
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Whole Blood ◽  
Point Of Care ◽  
False Negative ◽  
Sample Volume ◽  
High Dose ◽  
Control Line ◽  
Intermediate Range ◽  
Pregnancy Status

Abstract Background Point-of-care (POC) urine qualitative human chorionic gonadotropin (hCG) devices are used to rapidly assess pregnancy status, but many of these devices are susceptible to false-negative results caused by increased concentrations of hCG β core fragment (hCGβcf) that does not contain hCGβcf. Methods Purified hCG was added to hCG-negative heparinized whole blood to generate samples with known hCG concentrations, and the resulting samples were used to evaluate device sensitivity, low-end reproducibility, high-dose hook effect, intermediate range performance, acceptable sample volume, acceptable hematocrit range, and lot-to-lot variation. Device performance was also prospectively evaluated in 40 pregnant and 40 nonpregnant women aged 18–44 years in a hospital-based clinic or an academic hospital emergency department. Results All device observations were positive using a whole blood sample containing a plasma hCG concentration of 2.2 × 106 IU/L, and all device observations were positive from18 IU/L to 1.2 × 103 IU/L and from 2.5 × 104 IU/L to 2.2 × 106 IU/L. Three invalid results were observed in the intermediate range because of decreased control line intensity. The minimum sample volume was 30 μL, and maximum hematocrit was 46%. In 40 pregnant and 40 nonpregnant women aged 18–44 years, the device generated 100% concordance with urine qualitative and plasma quantitative test results. Conclusions The ADEXUSDx™ hCG test demonstrates acceptable performance for the determination of pregnancy status using capillary fingerstick samples.

scholarly journals False-Negative Results in Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Due to Excess hCGβ Core Fragment

2009 ◽  
Vol 55 (7) ◽  
pp. 1389-1394 ◽  
Author(s):  
Ann M Gronowski ◽  
Mark Cervinski ◽  
Ulf-Håkan Stenman ◽  
Alison Woodworth ◽  
Lori Ashby ◽  
...  
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Point Of Care ◽  
False Negative ◽  
The Core ◽  
Core Fragment ◽  
Negative Results ◽  
False Negative Results ◽  
Positive Results ◽  
Urine Specimens

Abstract Background: During pregnancy, human chorionic gonadotropin (hCG) immunoreactivity in urine consists of intact hCG as well as a number of hCG variants including the core fragment of hCGβ (hCGβcf). We identified 3 urine specimens with apparent false-negative results using the OSOM® hCG Combo Test (Genzyme Diagnostics) qualitative hCG device and sought to determine whether an excess of 1 of the fragments or variants might be the cause of the interference. Methods: We measured concentrations of hCG variants in the urine from 3 patients with apparent false-negative hCG results. Purified hCG variants were added to urines positive for hCG and tested using the OSOM, ICON® 25 hCG (Beckman Coulter), and hCG Combo SP® Brand (Cardinal Health) devices. Results: Dilution of these 3 urine samples resulted in positive results on the OSOM device. Quantification of hCG variants in each of the 3 patient urine specimens demonstrated that hCGβcf occurred in molar excess of intact hCG. Addition of purified hCGβcf to hCG-positive urines caused false-negative hCG results using the OSOM and ICON qualitative urine hCG devices. Conclusions: Increased concentrations of hCGβcf can cause false-negative results on the OSOM and ICON qualitative urine hCG devices. .

scholarly journals Improved Performance of Point-of-Care Human Chorionic Gonadotropin Pregnancy Device

2018 ◽  
Vol 64 (10) ◽  
pp. 1539-1541
Author(s):  
Christopher W Farnsworth ◽  
Robert D Nerenz ◽  
Ann M Gronowski
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Point Of Care ◽  
Improved Performance

scholarly journals A Point-of-Care Immunosensor for Human Chorionic Gonadotropin in Clinical Urine Samples Using a Cuneated Polysilicon Nanogap Lab-on-Chip

PLoS ONE ◽  
2015 ◽  
Vol 10 (9) ◽  
pp. e0137891 ◽  
Author(s):  
S. R. Balakrishnan ◽  
U. Hashim ◽  
Subash C. B. Gopinath ◽  
P. Poopalan ◽  
H. R. Ramayya ◽  
...  
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Point Of Care ◽  
Urine Samples ◽  
Lab On Chip ◽  
On Chip

scholarly journals Quantitative, Wide-Range, 5-Minute Point-of-Care Immunoassay for Total Human Chorionic Gonadotropin in Whole Blood

2004 ◽  
Vol 50 (6) ◽  
pp. 1026-1035 ◽  
Author(s):  
Piia von Lode ◽  
Jarmo Rainaho ◽  
Kim Pettersson
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Whole Blood ◽  
Point Of Care ◽  
Simple Procedure ◽  
Time Resolved ◽  
Rapid Assays ◽  
Wide Range ◽  
Future Challenges ◽  
One Step

Abstract Background: Human chorionic gonadotropin (hCG) is among the most common analytes available for point-of-care immunotesting, with most assays currently based on simple manual assay devices. However, as the importance of good analytical performance of rapid assays is increasingly emphasized, more sophisticated immunoassay techniques are needed to meet the future challenges of rapid yet quantitative POC testing. Methods: We developed a simple, dry-reagent, all-in-one immunoassay for the quantitative measurement of hCG in whole blood, plasma, or serum. The noncompetitive assay equally measures intact, nicked, and hyperglycosylated hCG as well as nonnicked and nicked hCG β-subunit with a rapid and simple procedure consisting of a 5-min, one-step incubation and, subsequent to washing, the measurement of time-resolved fluorescence directly from a wet well surface. Results: The assay had a detection limit (background + 3 SD) of 0.4 IU/L hCG. The within-run CV was <15% down to 2 IU/L, and the assay was linear to 6000 IU/L. The within- and between-run CVs in heparinized whole blood and plasma were ≤10% throughout the measured range (4.0–4400 IU/L). The mean (95% confidence interval) difference between whole blood and plasma was −42 (−24 to −61)% without hematocrit correction and 6.5 (−14 to 27)% with hematocrit correction (n = 106). Regression analysis with the Diagnostic Products IMMULITE® 2000 hCG method yielded the following: slope (SD), 1.02 (0.01); y-intercept (SD), −6 (10) IU/L; Sy|x = 99 IU/L (n = 124; range, 1.6–4746 IU/L; r = 0.995). Conclusions: Combined with the fully automated instrumentation, the 5-min, dry-reagent assay allows quantitative and reproducible determination of hCG in whole blood while sustaining the speed and simplicity of conventional rapid assays.

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