markdown-output/boston-biopharma-carestart-rapid-diagnostic-antige-bkzxkx7n.md

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# Goal/Experiment:
To evaluate the efficacy and procedure of the Boston Biopharma CareStart™ COVID-19 Rapid Diagnostic Antigen Test for the detection of SARS-CoV-2.

# Boston Biopharma CareStart™ Rapid Diagnostic Antigen Test

**Authors:**
- tclark¹ 
- Ahmad Hashem¹ 
- Jun Yong Ha² 
- Charlie Mize³

¹Boston Biopharma  
²Access Bio  
³Boston Biopharma

**Date:**
- Created: Sep 07, 2020
- Last Modified: Sep 08, 2020

**Keywords:**
- Covid-19 antigen test

**License:**
This is an open access protocol distributed under the terms of the [Creative Commons Attribution License](https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

**DOI:**
[dx.doi.org/10.17504/protocols.io.bkzxkx7n](https://dx.doi.org/10.17504/protocols.io.bkzxkx7n)

**Protocol Integer ID:**
- 41751

### Guidelines

- For prescription and *in vitro* diagnostic use only.
- This test has not been FDA cleared or approved.
- As with all diagnostic tests, all results must be interpreted with other clinical information available to the physician.
- Immediately use after opening the test device in the pouch.
- Follow the package insert to obtain accurate results.
- Avoid excess blood or mucus on the swab specimen to prevent interference with test performance.
- Avoid touching bleeding areas of the nasopharynx when collecting specimens.
- Do not interpret test results before 10 minutes or after 15 minutes of starting the test.
- Do not use the test device package if it is damaged.
- Do not use kit contents beyond the expiration date.

## Materials

### CareStart™ Antigen Kit Contents

| Contents Name                | Quantity (in a kit) | Description                                                                 |
|------------------------------|---------------------|-----------------------------------------------------------------------------|
| Test device                  | 20 each             | Foil-pouched test device containing one test strip enclosed in a plastic cassette. |
| Extraction vial / cap        | 20 vials and caps   | The extraction vial contains 400 ml of extraction buffer solution.          |
| Nasopharyngeal swab          | 20 each             | Swabs for nasopharyngeal specimen collection.                               |
| Positive control swab        | 1 each              | Recombinant SARS-CoV-2 nucleocapsid protein antigen dried on a foam-tipped head.  |
| Negative control swab        | 1 each              | Blank Universal Viral Transport media (BD UVT) dried on a foam-tipped head. |
| Package insert               | 1 each              | Instructions for use.                                                       |
| Quick Reference Instructions (QRI) | 1 each              | Quick reference instructions.                                       |

### Safety Warnings

- Do not eat, drink, or smoke in areas where specimens and kit contents are handled.
- Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.
- Dispose of used contents as biohazardous waste following federal, state, and local requirements.
- Wear nitrile or latex gloves when performing this test.
- If extraction buffer contacts the skin or eye, flush with water.
- Handle all specimens as if infectious.
- Follow established precautions against microbiological hazards.
- Sodium azide (in reagents) is harmful and may react with metals to form explosive azides. Ensure proper disposal.
- Do not interchange kit contents from different lots.
- Do not re-use any kit contents as they are for single-use only.

## Before Starting

- Store the test kit between 1 – 30°C.
- Do not use beyond the expiration date.
- Ensure the test device remains in the sealed pouch until use.
- Do not freeze any contents.
- Allow contents to equilibrate to room temperature (15 – 30°C) before testing.

## Procedure

### Temperature Equilibrium

1. **Room Temperature**
   - Allow test devices, reagents, specimens, and/or controls to equilibrate to room temperature (15 – 30°C).

### Nasopharyngeal Swab Specimen Collection

2. **Swab Removal**
   - Remove a nasopharyngeal swab from the pouch.

3. **Specimen Collection**
   - Place the swab into one of the patient’s nostrils and advance to the posterior nasopharynx.
   - Rotate the swab 3-5 times over the surface of the posterior nasopharynx.
   - Remove the swab from the nostril.

### Test Procedure

6. **Device and Extraction Vial Preparation**
   - Remove the test device and extraction vial from the pouch.

7. **Foil Seal Removal**
   - Peel off the aluminum foil seal from the extraction vial.

8. **Insert Swab**
   - Insert the swab into the extraction vial and rotate vigorously at least 5 times.

9. **Swab Removal**
   - Remove the swab while squeezing the sides of the vial to release liquid from the swab.

10. **Close Vial**
    - Close the vial with the provided cap.

11. **Mix Sample**
    - Mix the sample thoroughly by flicking the bottom of the tube.

12. **Sample Application**
    - Invert the extraction vial and hold above the sample well.
    - Squeeze the vial gently to allow three drops of sample to fall into the sample well.

13. **Reading the Result**
    - Read and interpret the test results at 10 minutes (do not read after 15 minutes).

### Interpretation of Results

14. **Results at 10 Minutes**
    - Test results should be read and interpreted no later than 15 minutes after application.
    
15. **Positive Result**
    - One red-colored line next to “C” and one blue-colored line next to “T” indicates a positive result.

16. **Negative Result**
    - One red-colored line only next to “C” indicates a negative result.

17. **Invalid Result**
    - If the red-colored line next to “C” is not visible, the result is invalid and the test must be re-run.

## Limitations

- Proper specimen collection, handling, storage, and preparation are crucial.
- The test indicates the presence of SARS-CoV-2 nucleocapsid protein from viable and non-viable virus.
- This is a qualitative test and does not provide viral concentration information.
- The test cannot rule out infections caused by other pathogens.

### Internal Quality Control

22. The CareStart™ COVID-19 Antigen test includes an internal procedural control that should show a red-colored line in the control region "C" to validate the test. If this line doesn't appear, the test is invalid and must be retested with a new device.

### External Quality Control

23. It is recommended to use external control swabs to validate each new lot shipment and user. If external control results are invalid, contact the manufacturer or distributor.

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