The Dropper Plus

Point-of-care urine dipstick control

The Dropper Plus from Quantimetrix Corp, Redondo Beach, Calif, is designed for point-of-care dipstick control. Its 1-month, room-temperature stability helps eliminate storage problems and provides portability, which is useful for sites without refrigeration. A new feature is the addition of creatinine and microalbumin. Values are provided for all analytes, and qualitative results for hCG for early pregnancy detection test methods are included. The control can be used with Multistix®, Chemstrip®, DiaScreen®, UriScan™, pH (Nitrazine paper), and other urinalysis reagent strips. It can be used for confirmatory tests, such as Acetest®, Clinitest®, Ictotest® reagent tablets, and refractometry. The product is liquid, human urine-based, and offers an 18-month unopened and open-vial stability when stored at 2°C to 8°C (from date of manufacture). A comparative quality control program, Quantrol™ provides labs with free monthly reports to monitor test performance and trend analysis.

Quantimetrix Corp
(800) 624-8380
www.4qc.com

QuickVue+ One-Step hCG Combo

Detects hCG in serum and urine

The QuickVue+® One-Step hCG Combo test from Quidel Corp, San Diego, is a user-friendly, sensitive immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum and urine for the early detection of pregnancy. The CLIA-waived test uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology to detect hCG in the universally recognized plus/minus format. With 10-mIU/mL sensitivity in serum and 20-mIU/mL sensitivity in urine, the test is able to detect low hCG levels as early as 2 to 3 days before expected menses. Results are obtained in 5 minutes for serum and in 3 minutes for urine, with greater than 99% sensitivity, specificity, and accuracy. The test can be stored at room temperature with a 21-month shelf life from date of manufacture. The procedure uses three drops of sample.

Quidel Corp
(800) 874-1517
www.quidel.com

QuPID Plus ER Pregnancy Test

10 mIU/mL sensitivity

Stanbio Laboratory, Boerne, Tex, offers an updated cassette design for its QuPID® Plus ER pregnancy test, which features increased sensitivity of 10 mIU/mL hCG in serum. It helps medical teams quickly determine the pregnancy status of trauma patients, and is reliable, specific, and sensitive. The test detects hCG in 3 minutes in urine or 5 minutes in serum. Specific monoclonal/polyclonal antibodies help ensure early pregnancy detection while preventing cross reactivity with hormones present in patient samples. The kit includes instructions printed on each individual test unit's foil pouch and a disposable plastic dropper.

Stanbio Laboratory
(800) 531-5535
www.stanbio.com

OSOM Trichomonas Rapid Test

Helps detect trichomonas vaginalis

The OSOM® Trichomonas rapid test offered by Genzyme Diagnostics, Cambridge, Mass, is a dipstick-simple, CLIA-waived, rapid test for the detection of trichomonas vaginalis. It is included in the CDC and ACOG guidelines. With less than 1 minute of hands-on time, the test provides objective results in 10 minutes or less. The test is antigen-based and does not require organism motility for accuracy. Wet-mount microscopy has a reported sensitivity of 58% versus culture, and the test provides more accurate results with a sensitivity of 83% versus culture. Studies have shown that trichomonas may increase the risk of preterm labor and low-birth-weight infants, neonatal infection, and cervical cancer; and may increase the susceptibility to HIV.

Genzyme Diagnostics
(800) 332-1042
www.genzymediagnostics.com

I.D.Rh(D) Noninvasive Prenatal Diagnostic

Diagnoses status of fetus

The new I.D.Rh(D) test from Biocept, San Diego, diagnoses the Rh(D) status of a fetus in an Rh(D)-negative pregnancy, and can be performed as early as in the 10th week of gestation. The test isolates fetal DNA circulating in the mother's whole blood, using proprietary I.D. (isolating fetal DNA)-platform technology (US patents pending). Fetal DNA is analyzed using quantitative real-time PCR in the company's CLIA-accredited clinical lab to determine Rh(D) genotype. Some 460,000 Rh(D)-negative women annually become pregnant nationwide. If their partners are Rh(D)-positive, which they are in about 89% of cases, the women risk carrying a fetus that is also Rh(D)-positive. When this occurs, the woman may develop antibodies that attack fetal red blood cells, leading to problems ranging from fetal anemia and jaundice to cerebral palsy, mental retardation, or even death. Physicians have routinely administered anti-D immune globulin injections, a human-blood product, to all Rh(D) negative women at 28 to 29 weeks of gestation. The test offers an alternative to the prophylactic injections and may help spare unnecessary injections in Rh-negative pregnancies.

Biocept
(888) 332-7729
www.biocept.com

OSOM BVBLUE

Rapid test helps diagnose bacterial vaginosis

OSOM® BVBLUE® from Genzyme Diagnostics, Cambridge, Mass, is a CLIA-waived rapid test that aids in the diagnosis of bacterial vaginosis. It detects elevated activity of vaginal-fluid sialidase, an enzyme produced by bacterial pathogens, such as gardnerella, mobiluncus, bacteroides, and prevotella. With less than 1 minute of hands-on time, the test provides objective results. The solution turns blue or green if positive, yellow if negative, and is 92.8% sensitive and 98% specific versus gram stain. Studies have shown that bacterial vaginosis may increase the risk of preterm delivery, low-birth-weight infants, endometritis, pelvic inflammatory disease, and miscarriage; and may increase the susceptibility to HIV and other STDs.

Genzyme Diagnostics
(800) 332-1042
www.genzymediagnostics.com