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BIOBASE Quick Inspection SARS-CoV-2 Antigen Rapid Test Kit — Colloidal Gold, Nasal Swab, 15–20 Minute Results, 20 Tests/Box

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SKU:
TH-BB-SC2AG-N20-BX
Weight:
2.20 LBS
Availability: 21-30 Days ETA.

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Description

Product Description

The BIOBASE Quick Inspection SARS-CoV-2 Antigen Test Kit (Colloidal Gold) is a rapid lateral-flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigen from a nasal swab specimen. The kit provides an easy-to-read visual result in approximately 15–20 minutes, supporting rapid screening in eligible international healthcare, workplace, institutional, and community settings.

BIOBASE offers two 20-test packaging configurations:

  1. Normal Package: Twenty tests supplied together in a standard multi-test box.
  2. Individual Package: Twenty separately packaged single-test units supplied within one box for convenient distribution and point-of-use handling.

Each test includes the primary components required for specimen collection, extraction, testing, and interpretation. No dedicated laboratory analyzer is required.

Distribution restriction: Manufacturer literature states that this product is not available for sale or distribution in the United States. Distribution is limited to countries where the product has the required registration, import authorization, and local regulatory clearance.

Key Features

  • Rapid qualitative SARS-CoV-2 antigen screening
  • Colloidal-gold lateral-flow technology
  • Nasal swab sample collection
  • Results available in approximately 15–20 minutes
  • Simple visual control-line and test-line interpretation
  • No laboratory analyzer required
  • Suitable for decentralized and point-of-care screening where legally authorized
  • Available in standard and individually packaged configurations
  • Twenty tests supplied per box
  • Manufacturer literature references CE and BfArM certification

Manufacturer-Reported Performance

Performance Metric Reported Value
Sensitivity 92.73%
Specificity 98.44%
Result Time 15–20 minutes
Test Format Colloidal-gold lateral-flow test
Specimen Type Nasal swab
Tests per Box 20

Performance figures are based on the manufacturer’s supplied literature and should be confirmed against the current product insert, certificate, and country-specific registration documentation before distribution.

Package Contents

Each test configuration includes the applicable combination of:

  • Sterile sample-collection swab
  • Sample-extraction buffer
  • SARS-CoV-2 antigen test card or cassette
  • Instructions for use
  • Individual packaging materials, where selected

Testing Procedure

  1. Collect the nasal swab specimen according to the instructions for use.
  2. Insert the swab into the extraction-buffer tube.
  3. Rotate and mix the swab in the buffer approximately 10–15 times.
  4. Remove the swab while extracting the liquid from the swab head.
  5. Attach the dispensing tip to the extraction tube.
  6. Add the specified number of drops to the test-card sample well.
  7. Read the result within 15–20 minutes.
  8. Do not interpret the test after 20 minutes.

Result Interpretation

  • Positive: Both the control line, “C,” and test line, “T,” are visible.
  • Negative: Only the control line, “C,” is visible.
  • Invalid: The control line does not appear, regardless of whether a test line is visible.

Positive or negative results should be interpreted according to applicable public-health guidance, clinical symptoms, exposure history, and local confirmatory-testing requirements.

Manufacturer Packaging Information

Normal Package

Shipping Configuration Approximate Carton Dimensions Gross Weight
1 box/carton 300 × 250 × 200 mm 1 kg / 2.20 lb
12 boxes/carton 650 × 440 × 430 mm 11 kg / 24.25 lb
16 boxes/carton 840 × 560 × 280 mm 14 kg / 30.86 lb

Individual Package

Shipping Configuration Approximate Carton Dimensions Gross Weight
1 box/carton 300 × 200 × 150 mm 0.5 kg / 1.10 lb
22 boxes/carton 460 × 350 × 350 mm 7.5 kg / 16.53 lb
50 boxes/carton 650 × 440 × 430 mm 15 kg / 33.07 lb

Packaging dimensions and weights should be confirmed on the final commercial invoice and packing list before shipment.

Intended Distribution Channels

  • Licensed medical distributors
  • Hospitals and healthcare systems
  • Clinics and diagnostic facilities
  • Occupational-health programs
  • Government and institutional procurement
  • Humanitarian and emergency-response organizations
  • Authorized pharmacies and community-screening programs
  • International wholesale and tender supply

Regulatory and Safety Notice

This is an in-vitro diagnostic medical product and must be imported, supplied, stored, administered, and disposed of in accordance with the destination country’s laws and the current manufacturer instructions. The test should not be marketed as a definitive standalone diagnosis. Negative results do not rule out infection, particularly when viral antigen levels are below the test’s detection threshold.

Not for U.S. sale or distribution unless and until the specific product has received all applicable FDA authorization, clearance, or approval. No FDA authorization is represented by this listing.

Warranty

Limited Warranty, Waivers and Limitations Limited Product Warranty BIOBASE SARS-CoV-2 Antigen Rapid Test Kits are warranted to be free from material defects in manufacturing, packaging, and workmanship when stored, transported, handled, and used strictly in accordance with the current Instructions for Use, product labeling, and applicable regulatory requirements. Unless otherwise stated in the applicable quotation, purchase agreement, or manufacturer documentation, the warranty period is limited to 12 months from the documented date of delivery and may not extend beyond the printed expiration date of the affected product. This limited warranty applies only to unopened, unused products that remain in their original packaging and have been maintained within the manufacturer-specified storage conditions. Exclusive Warranty Remedy For a verified warranty claim, the seller’s sole obligation and the purchaser’s exclusive remedy will be, at the seller’s discretion: Replacement of the verified defective units; Issuance of a credit for the affected units; or Refund of the original purchase price paid for the affected units. The seller is not responsible for replacement labor, testing expenses, disposal costs, freight, customs charges, business interruption, lost revenue, or any other incidental or consequential expense unless expressly agreed to in writing. Warranty Exclusions This warranty does not cover claims resulting from: Use after the printed expiration date; Improper storage, refrigeration, freezing, overheating, moisture exposure, or temperature excursion; Improper transportation, handling, repacking, relabeling, or distribution; Opening the sealed pouch before the product is ready for immediate use; Failure to follow the Instructions for Use; Incorrect sample collection, extraction, application, timing, or result interpretation; Use with unauthorized accessories, reagents, buffers, or collection devices; Product alteration, tampering, contamination, misuse, negligence, or abuse; Damage caused by fire, flood, accident, natural disaster, or other events beyond the seller’s reasonable control; Use outside the product’s intended purpose or outside an authorized jurisdiction; Normal variation in biological specimens or antigen concentration; False-positive, false-negative, inconclusive, or invalid results that are not attributable to a verified manufacturing defect; or Products purchased from an unauthorized reseller or without valid proof of purchase and lot traceability. Diagnostic and Clinical Waiver This product is an in vitro diagnostic screening device and is not intended to serve as the sole basis for diagnosis, treatment, isolation, discharge, or other clinical decisions. Test results must be interpreted together with: Patient symptoms; Exposure history; Epidemiological information; Current public-health guidance; and Confirmatory laboratory testing when clinically indicated. A negative result does not completely exclude SARS-CoV-2 infection. A positive result may require confirmation under applicable local protocols. The seller and manufacturer do not guarantee that the product will detect every infection or produce a correct result in every individual case. Performance Disclaimer Any sensitivity, specificity, accuracy, or other performance values displayed in product materials are based on manufacturer-supplied data and the study conditions identified in the applicable technical documentation. Actual performance may vary depending on specimen quality, disease stage, antigen concentration, circulating variants, operator technique, storage conditions, timing, patient characteristics, and other clinical or environmental factors. No performance statement constitutes a guarantee of an individual diagnostic outcome. Regulatory and Distribution Limitation The purchaser is responsible for confirming that the product is lawfully registered, imported, distributed, marketed, and used in the destination jurisdiction. Manufacturer literature states that this product is not available for sale or distribution in the United States. The product must not be offered, imported, distributed, or used in the United States unless the specific product has received all required authorization, clearance, approval, or exemption from the appropriate regulatory authorities. No FDA authorization, clearance, or approval is represented by this listing. Limitation of Liability To the fullest extent permitted by applicable law, the total cumulative liability of the seller, distributor, and manufacturer arising from the sale or use of the product will not exceed the amount actually paid for the specific affected units. Neither the seller, distributor, nor manufacturer will be liable for indirect, incidental, special, exemplary, punitive, or consequential damages, including loss of revenue, loss of business, loss of data, loss of opportunity, patient-management costs, testing expenses, or reputational harm. Nothing in this section excludes or limits liability that cannot legally be excluded or limited under applicable law. Disclaimer of Other Warranties Except for the limited written warranty stated above, the product is provided without any additional express or implied warranty. To the fullest extent permitted by law, all implied warranties—including merchantability, fitness for a particular purpose, non-infringement, and suitability for a specific clinical, institutional, governmental, or commercial application—are disclaimed. Certain jurisdictions do not permit limitations on implied warranties or consequential damages. In those jurisdictions, the limitations will apply only to the maximum extent legally permitted. Warranty Claim Requirements A warranty claim must be submitted promptly after discovery of the alleged defect and must include: Purchaser name and order number; Product name and SKU; Lot or batch number; Expiration date; Quantity affected; Photographs of the product and packaging; Description of the alleged defect; Storage and transportation records, when requested; Temperature-excursion information, when applicable; and Proof of purchase from an authorized seller. Affected products must not be destroyed, returned, altered, or discarded until written instructions are provided. Return authorization may be required before any product is shipped. Acceptance of Terms Purchase, receipt, resale, distribution, opening, or use of the product constitutes acknowledgment of these warranty terms, limitations, regulatory conditions, and product-use disclaimers, except where otherwise prohibited by applicable law.

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