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. 2020 Aug 26;2020(8):CD013705. doi: 10.1002/14651858.CD013705
Index testa Type of assayThroughputTime to result EquipmentKit storage Sample types Transport medium Sample storage Test interpretation
Antigen tests
SARS‐Cov‐2 Antigen Fluorescence Rapid Detection Kit (Beijing Savant)
IFU: not obtained; no mention of any COVID tests on website
IFU not obtained IFU not obtained IFU not obtained IFU not obtained IFU not obtained IFU not obtained
COVID‐19 Ag Respi‐Strip (Coris BioConcept)
IFU: 5723/TB/V03
CGIA (paper strip method)
Single test
15 min
Paper strips in a bottle with desiccant; LY‐S dilution buffer (3.5 mL or 15 mL; tubes and stoppers);
4 to 30 °C
NPs or culture extracted solution; samples must be liquid A gel or a sponge matrix can be used ASAP, any delay may result in a low signal intensity. If not, store frozen at −20 °C Visual; read through collection tube.
Control line only (negative), T line (with or without control (positive), no control line (invalid)
COVID‐19 Antigen Rapid Test Device (StrongStep®) (Liming Bio‐Products Co., Ltd)
IFU: obtained via Weitzel 2020 [A]; REF 500200 v1
CGIA
Single test
15 min
Test device, extraction buffer vial, extraction tubes, workstation for holding tubes
2‐30°C
NP or OP Not mentioned in IFU ASAP; can be held in clean, dry plastic tube or sleeve up to 72 h at 15‐30 °C, or 2‐8 °C before processing Visual; 2 coloured bands for positive; control band only for negative; test line only is invalid
BIOCREDIT COVID‐19 Ag (RapiGEN Inc)
IFU: I‐H0734‐E00(2020.04.03)
CGIA
Single test
5‐8 min
Test device, assay diluent tube and filter cap, swab for NP collection;
1‐40 °C
NP swab Not mentioned in IFU Test ASAP after collection; if storage required then 2‐8 °C for up to 12 h, or −20 °C for up to 24 h Visual; control line only (negative), control and test lines (positive), no control line (invalid)
BIOEASY 2019‐nCoV Ag Fluorescence Rapid Test Kit (Time‐Resolved Fluorescence) (Shenzhen Bioeasy Biotechnology Co, Ltd)
IFU: TS‐IU‐F027‐A2 (YRLF04401025/ YRLF04401050/ YRLF04401100)
FIA
Single test
10 min
Test card, extraction solution, extraction tube, dripper, swab and ID chip. Test runs on immunofluorescence analyser (supplied separately), transfer pipette also required Nasal swabs, throat swabs and deep sputum samples Not mentioned in IFU ASAP after collection, or store at 2‐8 °C for ≤ 24 h; or store at −70 °C for longer periods. Avoid repeated freezing and thawing (no more than 3 times). Automatic;
positive if both detection line and control line detect a fluorescent signal, and the detection line detection value is ≥ 0.005 ng/mL; negative if fluorescent signal on control line only; invalid if no fluorescent signal, or signal only on test line
Rapid molecular testsa
ID NOW COVID‐19 (Abbott Diagnostics Scarborough Inc)
IFU: IN190000 v1
Isothermal nucleic acid amplification
1 cartridge per run
5‐13 min
Sample receiver (with elution/lysis buffer), test base (with 2 sealed reaction tubes, each containing a lyophilised pellet), transfer cartridge for transfer of the eluted sample to the test base, positive and negative control swabs; requires ID NOW Instrument Throat, nasal, NP and OP swabs (direct testing or in listed VTM) Early versions of IFU documents multiple options but now not recommended (ID NOW COVID‐19 Product Insert, IN190000 Rev.3 2020/04:6‐8) ASAP after collection, otherwise hold in original package at room temperature (15‐30 °C) for up to 2 h. If longer then store at 2‐8 °C for up to 24 h from collection. No mention of frozen storage Automatic; results displayed on the instrument screen as positive, negative or presence or absence of COVID‐19 Viral RNAs cannot be determined
Xpert Xpress SARS‐CoV‐2 test (Cepheid)
IFU: XPRSARS‐COV2‐10
Automated RT‐PCR
1‐80 cartridges according to GeneExpert system used
45 min
Single‐use disposable cartridges that hold the RT‐PCR reagents and host the RT‐PCR process, transfer pipette; run on GeneExpert System NP swab in VTM Swab stored in viral transport tube containing 3 mL transport medium Store at room temperature (15–30 °C) for up to 8 h or refrigerate (2–8 °C) up to 7 days until testing performed Automatic; displayed positive (N2+ and E+, or N2+ only), presumptive positive (E+ only), negative (both negative), no result (repeat test), instrument error
Accula SARS‐Cov‐2 Test (Mesa Biotech Inc.)
IFU: LBL‐60058 Rev A (COV4100)
RT‐PCR + LFA
1 cartridge per run
30 min
Each test kit contains: test cassette, SARS‐CoV‐2 buffer (5.0 mL), single‐use fixed volume pipette, positive + negative control swabs; Accula or Silaris dock required to run test Throat swab and nasal swab per test; direct testing only
* check this ‐ Hogan 2020 reports use of NP swabs only Not recommended and will invalidate the test Prepared sample (in buffer vial) may be stored at room temperature for up to 24 h or refrigerated (2‐8b °C) and tested within 72 h of sample collection.
Sample may be stored for up to 1 week at −20 °C Visually interpretation (shown as blue test and control lines on exterior of test cassette): positive (any test line at T position, with or without control line C, but with no negative control line), negative (control line only with no negative control line), invalid (appearance of negative control line or all lines absent)
SAMBA II COVID‐19 Test (Diagnostics for the Real World Ltd)
IFU: REF 8500‐12
Isothermal PCR
Single test per run
1.5 h
Each test set contains 4 cartridges for extraction, amplification and detection of the amplification products, 2 ml SCoV buffer, fixed volume pipette, 300 μL + pipette tips or transfer pipettes 300 μL, sample collection tube and sample card; SAMBA II Assay Module and Tablet module both required to run the test;
2‐37°C
Combined nose and throat swabs, NP/OP swabs Direct testing or UTM/VTM can be used; no limitations on type of VTM recorded in IFU Store at 2‐30 °C for up to 18 h prior to testing.
Freezing of samples should be avoided
Automatic; presented and stored on the connected tablet ‐
Tablet module result: negative, positive, invalid, halted, read failure or no results;
Visual reading of test strip: internal control line only (Negative), ≥ 1 of 2 test lines (ORF and or N lines) with or without internal control line (positive), no lines (invalid); other combinations possible in rare cases
ASAP: as soon as possible; CGIA: colloidal gold immunoassay; IFU: instructions for use; NP: nasopharyngeal; NPS: nasopharyngeal swab; OP: oropharyngeal; RNA: ribonucleic acid; RT‐PCR: reverse transcription polymerase chain reaction; UVM: universal transfer medium; VTM: viral transport medium
aThe reported product codes are as reported in the instructions for use documents and may diverge from those evaluated in the included studies (product codes were reported in only two of 18 studies).