Clia Waived Tests

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What You Need to Know About CLIA Waived Tests by Lena Butler

When you need to get some lab tests done, either for yourself or for your home, you may encounter laboratories or facilities that declare themselves to offer CLIA waived tests. They would also probably have a certificate saying that hanging on a wall. But perhaps the question you may have would be: What are CLIA waived tests?

The CLIA 1988 Law

CLIA stands for Clinical Laboratory Improvement Amendments. It was a set of regulations passed by the United States government in 1988. Its purpose was to set and control the standards for clinical laboratory testing on any specimen or sample derived from the human body.

The goal of CLIA is to make sure that test results done in a clinical laboratory are timely, accurate and reliable. A clinical laboratory as defined under the CLIA law is a place where tests on specimens taken from the human body are conducted for the purposes of diagnosing and treating a disease.

The government agency that has jurisdiction when it comes to CLIA 1988 is the Centers for Medicare and Medicaid Services or CMS. The CMS performs supervisory and regulating tasks when it comes to CLIA, including granting certificates for CLIA waived testing in approved laboratories.

What Do CLIA Waived Tests Mean?

There are some kinds of lab tests that are considered to be CLIA waived. When a test is CLIA waived, it means that the test itself is so simple and accurate in itself that it is impossible to produce incorrect results in conducting them.

A test can also be CLIA waived if it is proven that it does not do any harm to the human body. In addition, a test becomes automatically CLIA waived if the Food and Drug Authority has approved its use at home.

The specific tests that are deemed to be CLIA waived are:

1. Non-automated urinalysis using dipstick or tablet reagents

2. Ovulation tests

3. Urine pregnancy tests

4. Fecal occult blood

5. Hemoglobin-copper sulfate

6. Erythrocyte sedimentation rate

7. Blood glucose monitoring utilizing devices specifically for home use

8. Spun microhematocrit

9. Hemoglobin testing done through devices with self-contained features and which give readout results via direct measurement

Laboratories that give CLIA waived tests have to renew their certification every two years and they have to conduct their tests in a controlled environment. The CMS does not conduct inspections of laboratories that offer CLIA waived testing except in case of complaints.

In other words, CLIA waived tests are safe as long as the instructions provided by their manufacturer are closely followed. If you need to send samples to a lab for a procedure that falls under the list of CLIA waived tests or if you need to use a home testing kit, no harm should come out of it. But if it did, you can always contact the CMS or the FDA to file a complaint.

This Article is written by Lena Butler, the author of Home Testing Kits a longer version of this article is located at What You Need to Know About CLIA Waived Tests, and resources from other home health and wellness testing articles are used such as CLIA Waived Testing.

Article Source: http://www.earticlesonline.com/Article/What-You-Need-to-Know-About-CLIA-Waived-Tests/782412

FEATURED PRODUCTS:

Check out these fine shops that offer Clia Waived Tests products:

Beckman Coulter Icon 25 hCG, CLIA Waived Pregnancy Test, 25/bx $43.54 Features of the Beckman Coulter Icon 25 hCG Pregnancy Test:In pregnancy testing, the new ICON® 25 hCG test will reshape your thinking. It gives you fast, accurate results, plus Beckman Coulter confidence. For the physician's office, ICON® 25 hCG offers CLIA waived simplicity for urine and a "moderately complex" catergorization for serum. For the hospital, it's the perfect complement to our ICON II HCG test, the gold standard in pregnancy testing.* Simple one-step process for reliability.* 3-minute result with urine; 5-minute result with serum.* Requires just 3 drops of specimen.* 25 mIU/mL sensitivity with > 99 percent specificity.* Room temperature storage, long shelf life.

Beckman Coulter Icon 25 hCG, CLIA Waived Pregnancy Test, 100/cs $157.09 Features of the Beckman Coulter Icon 25 hCG Pregnancy Test: In pregnancy testing, the new ICON® 25 hCG test will reshape your thinking. It gives you fast, accurate results, plus Beckman Coulter confidence. For the physician's office, ICON® 25 hCG offers CLIA waived simplicity for urine and a "moderately complex" catergorization for serum. For the hospital, it's the perfect complement to our ICON II HCG test, the gold standard in pregnancy testing. * Simple one-step process for reliability.* 3-minute result with urine; 5-minute result with serum. * Requires just 3 drops of specimen. * 25 mIU/mL sensitivity with > 99 percent specificity.* Room temperature storage, long shelf life.

Quidel Strep A Test in Line, CLIA Waived, 25/bx $99.99 Two-color results give you clear readability, and the proven accuracy of the QuickVue In-Line Strep A test provides dependable results. The 25 test kit is stored at room temperature and includes positive and negative external controls.

Clarity HCG Pregnancy Strip Tests, 50/Box $38.95 HCG Strips:*Sensitivity 20 ml U/ml.*Specificity 100% - No cross reaction with FSH/LH/TSH.*99% overall accuracy.*Available in boxes of 25, 50 & 100.*Dip & read.*18 month shelf life.*CPT Code 81025.*FDA Cleared and CLIA Waived.

Clarity HCG Pregnancy Strip Tests, 100/Box $69.56 HCG Strips:*Sensitivity 20 ml U/ml.*Specificity 100% - No cross reaction with FSH/LH/TSH.*99% overall accuracy.*Available in boxes of 25, 50 & 100.*Dip & read.*18 month shelf life.*CPT Code 81025.*FDA Cleared and CLIA Waived.

Clarity HCG Pregnancy Strip Tests, 25/Box $24.95 HCG Strips:*Sensitivity 20 ml U/ml.*Specificity 100% - No cross reaction with FSH/LH/TSH.*99% overall accuracy.*Available in boxes of 25, 50 & 100.*Dip & read.*18 month shelf life.*CPT Code 81025.*FDA Cleared and CLIA Waived.

Clarity Plus Glucose Strips, 50/bx $21.53 Clarity Plus Glucose Strips, CLIA Waived

ESA LeadCare II Reagent Test Kit, Box of 48 $386.39 CLIA-waived LeadCare® II point-of-care system The world’s only CLIA-waived blood-lead system, LeadCare II improves clinical outcomes and is ideal for the physicians’ offices, health clinics, or outreach-screening program. Contains reagents, controls, & supplies for 48 tests.

Immunostics Immuno Detector H. Pylori Test Kit, 10 Tests $74.99 Immunostics H.pylori Test Kit Features Include: Test for total Antibodies to H. Pylori. Sensitivity of 95.9% with 91.6% overall agreement to biopsy histology. Single reagent procedure. Results available in 10 minutes. CLIA waived for whole blood. Requires only 25 ul of whole blood or 10 ul serum plasma.

Stanbio Rely Mono Rapid Test, 20 Tests/Kit $52 Features of the Stanbio Rely Mono Rapid Test: Two-step test provides results in 5 minutes. CLIA waived for whole blood specimens, requiring minimal training. Multiple sample types (whole blood, serum or plasma). Procedural and external controls provided.

Inverness Medical Binax Now Influenza A+B Waived $339.65 The BinaxNOW Influenza A & B test kit is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in NP swabs, nasal swabs, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Influenza A & B Test Kit, CLIA Waived, Includes: 22 Test Devices, 22 Elution Solution Vials, 25 Transfer Pipettes, 22 NP Swabs, 1 A/B Positive Control Swab, 1 Viral Negative Control Swab, 22 test/kit

Wampole ClearviewNow Influenza Test, 10 Tests $198.68 Features of the Clearview NOW Influenza Test Kit: 15-minute test. Provides excellent sensitivity and specificity for the direct, qualitative detection of Influenza type A and B viral antigens. For use with nasopharyngeal swabs and nasal washes, this test distinguishes between types A and B on the same device. CLIA Waived. Kit includes everything necessary to perform test including +/- controls.

Accutest Urine Reagent Test Strips, 4-Parameter, 100/btl $18 Features of the Accutest Urine Reagent Test Strips: Tests for leukocytes, nitrite, protein and glucose High quality test strips. CLIA-waived when read visually. FDA Approved. Long shelf-life. FOR PROFESSIONAL USE ONLY.

Accutest Urine Reagent Test Strips, 2-Parameter, 100/btl $12 Features of the Accutest Urine Reagent Test Strips: Tests for protein and glucose High quality test strips. CLIA-waived when read visually. FDA Approved. Long shelf-life. FOR PROFESSIONAL USE ONLY.

Genzyme Osom hCG Urine Dipsticks, 50 Tests $57.4 Features of the Genzyme Osom hCG Urine Dipsticks: Avoid the hassle of manipulating urine samples with the reliability you need. For the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. Economical. Easy-to-read two color results. 25mIU/mL sensitivity. Results in as little as 1 minute. CLIA waived. Test Method: Color immunochromatographic dipstick. Specimen Type: Urine- Dip and read. Time to Result: Confirm negatives at 5 minutes. Sensitivity: 25 mIU/mL. Shelf Life: 18 months from date of manufacture.

CardioChek PA Metabolic Chemistry Panel, 15 tests/vial $133.61 Features of the CardioChek PA Metabolic Chemistry Panel: Measures glucose, HDL and triglycerides. Shelf-life is 89 weeks from date of manufacturing at room temp. No refrigeration required. Range:Glucose: 20-600 mg/dL (1.11 -33.3 mmol/L). HDL Cholesterol: 25-100 mg/dL (0.65-2.59 mmol/L). Triglycerides: 50-500 mg/dL (0.57-5.65 mmol/L). Time: about 2 minutes. Sampler: 40 ?L whole blood (fingerstick or venous). Analyzer: CardioChek PA only. CLIA: Waived.

Rapid Response Mono Test Kit, 15 Tests/Kit $37.02 Features of the Rapid Response Mono Test Kit: The Mononucleosis Rapid Test Cassette is a chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood, serum or plasma as an aid in the diagnosis of Infectious Mononucleosis. Results ready in 5 minutes. Overall accuracy of 99%. Overall sensitivity and specificity of 99%. FDA Cleared & CLIA Waived! Box Includes: 15 Test Devices. Disposable Sample Droppers for serum/plasma. Disposable Sample Droppers for fingerstick/whole blood. Sample buffer. Negative Control. Positive Control. Package Insert.

Trinity Uni-Gold Recombigen HIV-1 Blood Test Kit, 20 Tests $256 Features of the Trinity Uni-Gold Recombigen HIV-1 Blood Test Kit: Suitable for use in appropriate multi-test algorithms designed for the statistical validation of rapid HIV test results. CLIA Complexity: Waived (whole blood fingerstick and venipuncture); moderate (serum and plasma) Sensitivity: 100% Specificity: 99.7% Results in 10 minutes Single-use rapid immunoassay for the qualitative detection of antibodies to HIV-1 in serum, plasma and whole blood (venipuncture and fingerstick) Intended for use in point-of-care settings as an aid in diagnosis of infection with HIV-1 Uses proteins representing regions of the HIV virus Reactive result is indicated by a pink/red band in the test region of the device

Remel BACTi STAPH Test Kit, 150 tests/kit $219 Features of the Remel BACTi STAPH Test Kit: Rapid slide latex agglutination test provides qualitative detection to distinguish Staphylococcus aureus from other species of staphylococci.Includes: Latex reagent, positive and negative controls, disposable slides, and stirring sticks. CLIA Complexity: Non-waived CPT Code: 87147 Ready to use; no further preparation necessary Four-step procedure Utilizes protein-coated latex particles capable of detecting both clumping factor and Protein A simultaneously Use with suspected S. aureus colonies Results in 60 seconds For in vitro diagnostic use

Clarity Ketocheck Urinalysis Strips, 100/Box $12.99 Clarity Ketocheck Urinalysis Strips test for Ketone in the urine. *Manually dipped and read. *18 month shelf life. *100 tests per bottle. *CPT Code 81000 with microscopy. *CPT Code 82000 without microscopy. *FDA Approved and CLIA Waived.

Clarity Urocheck 2GP Urinalysis Strips, 100/Bottle $19.95 Clarity Urocheck 2GP Urinalysis Strips test for Glucose and Protein in the urine. *Manually dipped and read. *18 month shelf life. *100 tests per bottle. *CPT Code 81000 with microscopy. *CPT Code 82000 without microscopy. *FDA Approved and CLIA Waived.

Clarity Urocheck 7, 100 per Box $35.99 Features of the Clarity Urocheck 7 Glucose, Ketone, Blood, PH, Protein, Nitrate, Leukocytes. Manually dipped and read. 18 month shelf life. 100 tests per bottle. CPT Code 81000 with microscopy. CPT Code 82000 without microscopy. FDA Approved and CLIA Waived.

Clarity HCG Combo Cassettes, 50/Box $39.24 Clarity HCG Combo Cassettes are pregnancy tests that may be used with urine or serum.Sensitivity 20 ml U/ml. Specificity 100% - No cross reaction with FSH/TSH/LH. 99% overall accuracy. Box of 50. 18 month shelf life. CLIA waived for urine samples. CLIA moderate for serum samples. CPT Code 81025 for urine. CPT Code 84703 for serum. FDA Approved.

QuickVue Influenza A+B test, 25 tests per Box $499.99 Quidel’s CLIA-waived QuickVue® Influenza A+B test provides you with differential A or B test results allowing you to test and treat in just one visit. Prompt type-specific diagnosis enables a choice of antiviral therapy, helps avoid the overuse of antibiotics, and prevents healthcare costs related to unnecessary testing and treatment. The QuickVue Influenza A+B test has also been shown to detect cultured avian influenza viruses, including avian Influenza A subtype H5N1 virus; however, as with other rapid tests for influenza, the ability of the QuickVue Influenza A+B test to detect influenza Type A in patients infected with H5N1 has not been established. The QuickVue Influenza A+B test is CLIA waived, sensitive and specific, giving you the results you need. Right. Now.Rapid Diagnosis and Treatment* Identifies influenza Type A or B in positive samples, in about 10 minutes, for better patient management decisions.* Most patients tested can be diagnosed and treated injust one visit. Accurate Detection* QuickVue® Influenza A+B test detects both types A and B viral antigens.* Accurate detection with nasal swab samples:94% sensitivity and 90% specificity for type A70% sensitivity and 97% specificity for type BEasy to Use* 3 steps1 reagent, 90 seconds hands-on time.* 1 test procedure provides results for both A and B.Convenient Packaging* Each kit contains everything needed to perform the test, including foam-tipped nasal swabs and Positive and Negative Controls.* Available in 25-test kit.* Room temperature storage with 24-month shelf life from date of manufacture.* Transport swab set also available separately.Features and Benefits:Feature: Provides A or B results from one test procedure.Benefit: No redundant procedure required for differentiated resultsFeature: Two-color Result.Benefit: Easy to read test results. Decreased risk of misinterpretation. Feature: 10 Minutes to Result.Benefit: Allows prompt diagnosis and treatment while patient is still in office. Increases office efficiency and reduces patient follow up activities.Feature: 3 Step Procedure.Benefit: Fewer procedural steps. Decreased risk of operator error.Feature: Pictorial Procedure Guide.Benefit: Simplifies understanding of testing procedure. Increases reliability.Feature: Room Temperature Storage.Benefit: No reagent warm-up. Use as needed without waiting. Does not take up refrigerator space.Feature: 24 Month Dating from date of manufacture.Benefit: Long shelf life. Economical test for low & high volume labs.Feature: Built-in Internal Control.Benefit: Ensures system integrity.Feature: Kit Includes External Controls.Benefit: Facilitates internal laboratory quality control. No additional ordering needed.

Roche Diagnostics Urisys 1100 Urine Analyzer $1069 Features of the Roche Diagnostics Urisys 1100 Urine Analyzer: 70 second measuring cycle Incubation time is approximately 55 to 65 seconds 100 sample memory For evaluation of the well-proven Chemstrip urine test strip CLIA Waived Kit Contents: Thermal Printer Specifications: 150 X 290 X 95 mm, LCD Display, AC Power, Automated, Semi Quantitative. Throughput: 50 Tests / Hour

Rapid Response 100 Urine Analyzer, Semi Automated $649.99 Features of the Rapid Response 100 Urine Analyzer:* The ideal choice for small labs, nursing homes, walk-in clinics & physicians’ offices.* FDA Cleared & CLIA Waived.* 60 tests/hour.* Internal memory of last 1000 readings.* Virtually noiseless.* Compact space saving design.* Large bright LCD screen.* Results in 60 seconds.

CardioChek Test Strips, Lipid Panel, 15/bx $202.61 Features of the CardioChek Test Strips: For use with Cardiochek PA Only. A reliable and accurate lipid point-of-care test method enables healthcare professionals to easily test and immediately counsel their patients on lipid-lowering therapies, to understand their risk for developing coronary heart disease, their medication regimen, and the benefits of long-term persistence of therapy. FDA approved tests which are exempt or waived from CLIA regulation as a result of being simple to carry out and making inaccuracy nearly impossible.

Accutest Immunological Fecal Occult Blood Test Kits without Mailers, 25/bx $92.42 Features of the Accutest Immunological Fecal Occult Blood Test Kits: Immunoassay test specific to human hemoglobin Rapid 2-step test with results in just 5-10 minutes. CLIA-waived. Sensitivity 99.2%, Specificity 96.7%, Accuracy 98.3% Extended stability of sample in buffer solution (18 days at room temp/6 months refrigerated). No dietary or drug restrictions for patient. Item includes: 25 tests and 25 collection tubes. FOR PROFESSIONAL USE ONLY.

Accutest Accustrip Urine Reagent Test Strips URS 10, 100/btl $27 Features of the Accutest Accustrip Urine Reagent Test Strips URS 10: Tests for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketone, Glucose, pH, Specific Gravity and Leukocytes High quality test strips. CLIA-waived when read visually or with the Accustrip URS Reader. FDA Approved. Long shelf-life. Best available protection against Vitamin C interference. Reliable accuracy. FOR PROFESSIONAL USE ONLY.

Accutest Dual-Sample Immunological Fecal Occult Blood Test Kits, 20/bx $158.01 Features of the Accutest Dual-Sample Immunological Fecal Occult Blood Test Kits: A unique immunological Fecal Occult test that allows for two samples to be tested on the same card. Rapid 2-step test with results in just 5-10 minutes. CLIA-waived. Immunoassay test specific to human hemoglobin. Extended stability of sample in buffer solution (18 days at room temp/6 months refrigerated). 20 tests and 20 patient collection kits. No dietary or drug restrictions for patient. Sensitivity 99.2%, Specificity 96.7%, Accuracy 98.3% FOR PROFESSIONAL USE ONLY.

A great place to shop for Clia Waived Tests products is Amazon.

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