Alpine Biomedicals Covid 19 Rapid Antigen Test Kit
Fine Morning Pharma
Product highlights
- The Alpine COVID-19 Rapid Antigen Test is a rapid, in-vitro diagnostic device using immunochromatography to qualitatively identify SARS-CoV-2 antigens in nasal swab samples from individuals exhibiting or lacking symptoms.
- The ICMR, India's medical research council and a World Health Organization-recognized evaluator of medical devices, has granted approval to the Alpine antigen test kit.
- Convenient at-home or on-site COVID-19 rapid antigen self-testing, eliminating the need for laboratory processing.
- Individuals 12 years and older are eligible for this test. Its applications span residential, commercial, institutional, and travel settings.
- Collect a nasal sample with a swab, immerse it in the provided solution vial, add several drops to the testing device, and observe the outcome within 15–20 minutes. Supporting visuals are included.
- The test cassette will show the outcome; the presence or absence of C and T lines indicates the test result.
Overview Alpine Biomedicals Covid 19 Rapid Antigen Test Kit
The Alpine Biomedicals Rapid Antigen Test for COVID-19 detects the SARS-CoV-2 virus, a betacoronavirus causing acute respiratory illness. Humans are highly susceptible, with infected individuals (including asymptomatic carriers) serving as the primary transmission source. The incubation period typically ranges from 1 to 14 days (most commonly 3-7 days), presenting with symptoms like fever, fatigue, and dry cough. Other symptoms, such as nasal congestion, rhinorrhea, sore throat, myalgia, and diarrhea, are less frequent. This one-step immunochromatographic assay identifies the viral nucleoprotein antigen in nasal or nasopharyngeal swabs. Viral antigens are chemically extracted, then detected using solid-phase immunoassay. COVID-19 monoclonal antibodies conjugated to colloidal gold bind to the antigen; this complex migrates to the test zone, creating a visible pink line (positive result). A control line verifies proper test function. This kit determines active COVID-19 infection. Results, obtained in 15-20 minutes, aid healthcare providers in treatment decisions. Knowing your infection status helps limit transmission. The easy-to-use kit includes a nasopharyngeal swab, extraction buffer, test card, and instructions. Specimen collection involves swabbing both nostrils, placing the swab in the extraction tube, and mixing for 10 seconds. Two drops of the solution are added to the test card; results are read within 15 minutes (positive results appear sooner, but negative results require the full 15 minutes; results after 20 minutes are invalid). A single line (C-line) indicates a negative result; two lines (C-line and T-line) indicate a positive result. Invalid tests show no C-line. Follow all instructions carefully for accurate results. Handle specimens and materials according to biosafety protocols. Protect the kit from moisture and damage; use within the expiry date. Balance reagents and samples to room temperature (15-30°C) before use. Do not reuse components. Undiluted samples are required. Store as instructed; avoid freezing. Negative results may be due to antigen levels below the detection limit. Follow proper waste disposal procedures. Avoid eating, drinking, or smoking near specimens. Avoid strong airflow during testing. This kit is for in vitro diagnostic use only, with nasopharyngeal swabs; other specimen types may yield inaccurate results. It provides qualitative, not quantitative, detection. Positive results warrant further testing and clinical evaluation. Negative results don't rule out infection; confirm with other tests (e.g., PCR, ELISA) if necessary. Further testing is recommended for a definitive immune status. Antigens are viral proteins; detection confirms active infection. Nasal swabbing may cause mild discomfort; follow instructions carefully. Suitable for all ages (adults should assist children under 14). This test detects only active infections, not past infections. The kit has an expiration date. Use only provided components; each test is single-use. Dispose of the used kit components in a sealed bag as biohazardous waste. A positive result indicates the presence of COVID-19 antigens, requiring self-isolation and consultation with a healthcare professional. It does not exclude co-infections. A negative result does not guarantee absence of COVID-19; a false-negative can result from low antigen levels, early-stage infection, improper technique, or poor specimen quality. If symptomatic with a negative result, seek further testing (RT-PCR) and consult a physician. This test is authorized for home use (self-collected nasal swabs for individuals 18+ or adult-collected for those 2+). See [link to Ministry of Health website].
How to Use Alpine Biomedicals Covid 19 Rapid Antigen Test Kit:
Sample acquisition and processing—
Safety Instruction of Alpine Biomedicals Covid 19 Rapid Antigen Test Kit:
- Thoroughly review the kit's directions prior to use, and precisely adhere to the specified reaction duration. Deviation from these instructions will yield unreliable results.
- Laboratory analysis of the sample must adhere to specific protocols. All samples and materials used during testing must follow established infectious disease laboratory procedures.
- Protect from humidity; the foil pouch should remain unopened until testing commences.
- Avoid using the aluminum pouch if it's compromised or the test strip is moist.
- Administer the medication before the expiration date.
- Allow all reactants and samples to reach ambient temperature (15-30°C) prior to use.
- Use only the components included in this kit.
- Undiluted samples are required for accurate test results.
- This kit must be stored precisely as detailed in this instruction booklet. Avoid freezing temperatures when storing the kit.
- This specification mandates strict adherence to its guidelines for interpreting test methodologies and findings.
- This kit will yield negative results if the sample's novel coronavirus antigen concentration is below the test's detectable threshold.
- Refrain from smoking, drinking, or consuming food in areas where samples or test components are being processed.
- Properly discard all test samples and materials as infectious waste.
- Avoid testing in areas with significant air currents, such as those produced by fans or air conditioners.

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