FDA Approved for Global Export
Allergy
Alpha-Fetoprotein Test (AFP)
Alpha-Fetoprotein Test (AFP)
Amphetamine (AMP)
Approved for Sale in the USA
BACTERIAL
Barbiturate (BAR)
Benzodiazepine (BZD)
Blood Alcohol Concentration (BAC)
Cancer Markers
Carcinoembryonic antigen (CEA)
Chlamydia
Chlamydia
Cholera
Cholesterol
CLIA WAIVED
Cocaine (COC)
Colorectal Cancer
COVID-19
CRP: C Reactive Protein
Dengue Fever
Disposable CPE Shoe Covers
Drug Tests
Ebola
Ecstasy (MDMA)
Endocrine Health
Face Masks
FDA APPROVED
FDA EMERGENCY USE AUTHORIZED
Fecal Occult Blood (FOB)
Fertility
Glucose Rapid
Gonorrhea
Gonorrhea
H-Pylori
Heart Health
HEPATITIS B
Hepatitis B
Hepatitis C
HIV/AIDS
HIV/AIDS
HSV-1 (Herpes Simplex Virus 1)
HSV-1 (Herpes Simplex Virus 1)
HSV-2 (Herpes Simplex Virus 2)
HSV-2 (Herpes Simplex Virus 2)
Immunoglobulin E (Ige)
Infectious Diseases
Influenza A
Influenza B
Malaria
Marijuana (THC)
Menopause
Methadone (MTD)
Methamphetamine (MET)
Mononucleosis
Mononucleosis
Multi-panel Drugs Tests
Myoglobin
Opiate (OPI)
OVER-THE-COUNTER APPROVED
Ovulation
Oxycodone (OXY)
PARASITIC
Phencyclidine (PCP)
POINT-OF-CARE-TEST
Pregnancy
Professional and OTC
Prostate-Specific Antigen (PSA)
Rubber Gloves
STD/STI
Strep A
Syphilis
Syphilis
Thermometers
Thyroid-Stimulating Hormone (TSH)
Tricyclic Antidepressant (TCA)
Troponin
Tuberculosis
Urinalysis Reagent Strips
Urine
Viral
White or Blue Tape Disposable Hazmat Suits
ZIKA Virus
Antigen (Np Test) Access Bio
Kit of 25 tests: $647.00 $25.880
($25.88 per test)
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
MATERIALS SUPPLIED
- 20 Test Devices
- 20 Assay Buffer
- 20 Extraction vials and caps
- 20 Specimen Collection Swabs
- 1 Positive and 1 Negative Control Swabs
- Instructions
FEATURES
- Rapid results within 10-15 minutes
- Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- For use under the Emergency Use Authorization (EUA) only
- For in vitro diagnostic use only
- For prescription use only
- For use with direct anterior nasal and nasopharyngeal swab specimens
- Clinical Performance (PPA: Positive Percent Agreement, NPA: Negative Percent Agreement)
- 93.75% PPA and 99.32% NPA when used with a nasopharyngeal swab
- 87.18% PPA and 100% NPA when used with an anterior nasal swab
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